Elizabeth Mechcatie

The manufacturer of liraglutide has issued a letter to health care professionals reminding them about the increased risk of pancreatitis associated with treatment in patients as well as informing them about the development of thyroid tumors in rodents exposed to clinically relevant doses of liraglutide, the Food and Drug Administration announced on June 13.

The information is not new, but the letter is being sent to clinicians because "a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza," according to the FDA statement. Victoza is the trade name for liraglutide (rDNA origin) injection, which is a glucagonlike peptide-1 (GLP-1) receptor agonist approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The letter describes the "potential risk" of thyroid C-cell tumors, including medullary thyroid carcinoma, which may be associated with liraglutide. In both genders of rats and mice, liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors" at clinically relevant exposures, but the relevance to humans cannot be ruled out by clinical or nonclinical studies, according to the letter. In addition, pancreatitis was more common among patients treated with liraglutide, compared with comparators in clinical trials, so the drug may increase the risk of acute pancreatitis.

Because of these risks, liraglutide is not recommended as first-line therapy, and patients should be observed closely for signs and symptoms of pancreatitis after starting treatment and after dose increases. The company is monitoring cases of medullary thyroid cancer registry cases to determine whether there was an increase in cases associated with the availability of liraglutide in the United States.

More information including a link to the letter is available in the FDA statement. Serious adverse events associated with liraglutide should be reported online at MedWatch or by phone at 800-332-1088 or to Novo Nordisk at 877-484-2869.

The manufacturer of liraglutide has issued a letter to health care professionals reminding them about the increased risk of pancreatitis associated with treatment in patients as well as informing them about the development of thyroid tumors in rodents exposed to clinically relevant doses of liraglutide, the Food and Drug Administration announced on June 13.

The information is not new, but the letter is being sent to clinicians because "a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza," according to the FDA statement. Victoza is the trade name for liraglutide (rDNA origin) injection, which is a glucagonlike peptide-1 (GLP-1) receptor agonist approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The letter describes the "potential risk" of thyroid C-cell tumors, including medullary thyroid carcinoma, which may be associated with liraglutide. In both genders of rats and mice, liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors" at clinically relevant exposures, but the relevance to humans cannot be ruled out by clinical or nonclinical studies, according to the letter. In addition, pancreatitis was more common among patients treated with liraglutide, compared with comparators in clinical trials, so the drug may increase the risk of acute pancreatitis.

Because of these risks, liraglutide is not recommended as first-line therapy, and patients should be observed closely for signs and symptoms of pancreatitis after starting treatment and after dose increases. The company is monitoring cases of medullary thyroid cancer registry cases to determine whether there was an increase in cases associated with the availability of liraglutide in the United States.

More information including a link to the letter is available in the FDA statement. Serious adverse events associated with liraglutide should be reported online at MedWatch or by phone at 800-332-1088 or to Novo Nordisk at 877-484-2869.

The manufacturer of liraglutide has issued a letter to health care professionals reminding them about the increased risk of pancreatitis associated with treatment in patients as well as informing them about the development of thyroid tumors in rodents exposed to clinically relevant doses of liraglutide, the Food and Drug Administration announced on June 13.

The information is not new, but the letter is being sent to clinicians because "a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza," according to the FDA statement. Victoza is the trade name for liraglutide (rDNA origin) injection, which is a glucagonlike peptide-1 (GLP-1) receptor agonist approved by the FDA in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The letter describes the "potential risk" of thyroid C-cell tumors, including medullary thyroid carcinoma, which may be associated with liraglutide. In both genders of rats and mice, liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors" at clinically relevant exposures, but the relevance to humans cannot be ruled out by clinical or nonclinical studies, according to the letter. In addition, pancreatitis was more common among patients treated with liraglutide, compared with comparators in clinical trials, so the drug may increase the risk of acute pancreatitis.

Because of these risks, liraglutide is not recommended as first-line therapy, and patients should be observed closely for signs and symptoms of pancreatitis after starting treatment and after dose increases. The company is monitoring cases of medullary thyroid cancer registry cases to determine whether there was an increase in cases associated with the availability of liraglutide in the United States.

More information including a link to the letter is available in the FDA statement. Serious adverse events associated with liraglutide should be reported online at MedWatch or by phone at 800-332-1088 or to Novo Nordisk at 877-484-2869.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised just a few years ago, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised just a few years ago, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised just a few years ago, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

A newer set of criteria used to flag potentially inappropriate medicines prescribed in older patients was better at identifying avoidable adverse drug-related events that led or contributed to hospitalizations than was a preexisting tool, according to an Irish study of ambulatory people aged 65 years and older.

STOPP (Screening Tool of Older Persons’ Potentially Inappropriate Prescriptions) could "be highly valuable as a routine screening tool," concluded Dr. Hilary Hamilton and her coauthors at University College Cork, Ireland, in the June 13 issue of Archives of Internal Medicine (2011;171:1013-19). The researchers belong to the same study group that devised and validated STOPP in the late 2000s.

In the more recent, prospective study, they compared use of the two sets of criteria in identifying potentially inappropriate medicines that could cause adverse drug events in 600 patients admitted to a university hospital with an acute illness over a 4-month period. Their median age was 77 years, and they were on a median of seven medications (range 1-27).

The STOPP criteria are organized by physiological system. Devised in the late 2000s, the tool flags possible drug interactions, duplicate drug-class prescriptions, and the use of certain medications in patients with current falls, among other potential problems.

In contrast, the latest (2003) version of the Beers criteria, first published in 1991, uses two lists of drugs that should be avoided in older people, one that is independent of the diagnosis and one that considers the diagnosis. Dr. Hamilton and her coauthors pointed out that the lists include drugs that are not available in European countries, and that the results of studies on the association between the potentially inappropriate medicines identified with the Beers criteria and adverse drug events have been mixed.

Of the 600 patients, 158 (26%) had 329 adverse drug events. Of these 329 events, 36 (11%) were considered to be the main cause of the hospitalization, and 183 (56%) were considered a significant contributory factor to the hospitalization. Of these 219 causal or contributory cases, 151 (69%) were determined to be "avoidable or potentially avoidable."

Significantly more of the adverse drug events that were due to potentially inappropriate medicines were identified using the STOPP criteria: Of the 329 adverse drug events, 170 (52%), compared with 67 (20%) that were identified with the Beers criteria.

Of the 329 adverse drug events, 235 or 71% were classified as avoidable or potentially avoidable, of which 68% were identified as potentially inappropriate medicines by the STOPPS criteria compared with 29% of cases using Beers criteria.

In addition, the likelihood of patients experiencing an adverse drug event was nearly 85% higher if they were prescribed a medicine that was identified as being potentially inappropriate with the STOPP criteria than a medicine not identified as potentially inappropriate with these criteria, after adjusting for age, sex, comorbidity, chronic cognitive impairment, baseline activities of daily living, and number of medications.

However, treatment with a medication deemed potentially inappropriate using the Beers criteria was not associated with a significant increase in adverse-event risk, they said.

The results indicate that the STOPP criteria are more sensitive than the Beers criteria for identifying those potentially inappropriate medicines that result in adverse drug events, "and are therefore more clinically relevant," the authors concluded.

The researchers wrote that not including over-the-counter medications was among the study’s limitations, and that the criteria are not meant to replace clinical judgment but "are designed to enhance clinical evaluation of pharmacotherapy in older patients."

They also wrote that the STOPP criteria, which address common avoidable cases of inappropriate prescribing, are designed to be used with the START (Screening Tool to Alert Doctors to Right Treatment) criteria, which represent "the more common instances of inappropriate omission of potentially beneficial medication for no valid clinical reasons." The authors referred to the "substantial" prevalence of potentially inappropriate omission of beneficial drugs in older people in both primary care (23%) and hospital settings (58%).

In an accompanying editorial, Dr. Jeffrey Schnipper, of the division of general internal medicine, Brigham and Women’s Hospital, Boston, said the study is important because "it facilitates the design of better interventions to improve medication safety among ambulatory elderly patients." He added that incorporating this information into electronic prescribing and outpatient pharmacy systems would be "the most obvious" application. He had no financial disclosures.

Funding for the study was provided by the Health Research Board of Ireland and Enterprise Ireland. The authors had no financial disclosures.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Ezogabine has been approved as adjunctive therapy for partial onset seizures in adults but will not be available until later this year.

Ezogabine is the first neuronal potassium channel opener approved for treating epilepsy, according to a Food and Drug Administration statement issued on June 13 announcing the approval. "Although the mechanism of action is not firmly established, the drug may act as an anticonvulsant by reducing excitability through the stabilization of neuronal potassium channels in an ‘open’ position," the FDA statement said.

Ezogabine, which will be marketed as Potiga, was developed by Valeant Pharmaceuticals North America and will be distributed by GlaxoSmithKline.

A statement issued by GSK on June 13 said that the FDA has recommended that ezogabine be scheduled as a controlled substance and that final classification was under review by the Drug Enforcement Administration. The drug is expected to be available in U.S. pharmacies by the end of 2011, after this process is completed, according to GSK.

The most common adverse reactions associated with ezogabine in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, attention problems, memory impairment, and lack of strength, according to the FDA. Other possible adverse events include hallucinations, psychotic symptoms and other neuropsychiatric symptoms, which typically resolve within 7 days of stopping the drug, according to the FDA.

Urinary retention, which usually presents during the first 6 months of treatment, is another side effect associated with ezogabine, so urologic symptoms in treated patients should be carefully monitored, the FDA statement said.

The GSK statement said that the FDA has determined that a Risk Evaluation and Mitigation strategy to inform health care professionals about the risk of urinary retention is needed for the drug.

At a meeting in August 2010, an FDA advisory panel unanimously agreed that ezogabine had been shown to be effective as adjunctive therapy for partial onset seizures, but recommended that treated patients be closely monitored for the development of urinary retention. Members of the panel agreed that the risk of urinary retention could be mitigated by monitoring patients, pointing out the importance of educating clinicians in how to properly evaluate patients for changes in urinary symptoms.

Ezogabine was approved in the European Union in March 2011. Outside of the United States, it is known as retigabine and is marketed as Trobalt, according to GSK.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.

Information about the increased risk of high-grade prostate cancer diagnoses associated with the use of finasteride and dutasteride has been added to the prescribing information for the two 5-alpha reductase inhibitors, which are approved to treat benign prostatic hyperplasia, the Food and Drug Administration announced on June 9.

These labeling changes are the result of the FDA’s review of two randomized studies, which evaluated the impact of 5-alpha reductase inhibitors (5-ARIs) in reducing the risk of prostate cancer when taken daily in 27,000 men aged about 50 years and older who were considered at an increased risk of developing prostate cancer. The Prostate Cancer Prevention Trial (PCPT) evaluated daily use of finasteride 5 mg versus placebo for 7 years, and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial evaluated daily use of dutasteride 0.5 mg versus placebo for 4 years. In those two studies, the risk of being diagnosed with prostate cancer was significantly reduced among those randomized to either of the two drugs, compared with those on placebo. But the reduction was because of a lower rate of lower-grade prostate cancers (with a Gleason score of 6 or lower). The risk of higher grade prostate cancers (with a Gleason score of 8-10) was increased among those who received one of the two 5-ARIs.

"This risk appears to be low, but health care professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men," according to the statement.

Before prescribing one of these drugs, the statement advises that health care professionals "perform appropriate evaluation to rule out other urological conditions, including prostate cancer, [which] might mimic" benign prostatic hyperplasia (BPH).

The information has been added to the warnings and precautions section of the labels for 5-ARIs. Dutasteride is marketed as Avodart and is also available in combination with tamsulosin (Jalyn). Finasteride is marketed as Proscar (5-mg dose, for BPH) and Propecia (1-mg dose, approved for treating male pattern hair loss). None of these products is approved to prevent or reduce the risk of prostate cancer.

The results of these studies were the focus of a meeting of the FDA’s Oncologic Drugs Advisory Committee in December 2010. Citing the increases in high-grade prostate cancers among the treated men in these studies, the majority of the panel voted that the two drugs, when used as chemopreventive agents for reducing the risk of prostate cancer, had an unfavorable risk-benefit profile.

The full advisory is available at the FDA. Serious adverse events associated with 5-ARIs should be reported to MedWatch or by calling 800-332-1088.