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Zika’s 2017 summer less active than 2016
Zika may not have gone away this summer, but it didn’t make a comeback, either.
New cases in pregnant women are still being reported, but the numbers are much lower than a year ago, when the infection was kicking into high gear. For the 2 weeks ending Aug. 22, 106 pregnant women with laboratory evidence of Zika virus infection were reported: 43 in the U.S. states and the District of Columbia, and 63 in the U.S. territories, according to the Centers for Disease Control and Prevention.
The total cases reported for the previous 2-week periods, going back to mid-June, look like this: 102 (June 14-27), 160 (June 28–July 11), 95 (July 12-25), and 103 (July 26–Aug. 8). In the summer of 2016, the 2-week period of Aug. 12-25 produced 375 new reports of Zika-infected pregnant women, the CDC data show.
Zika may not have gone away this summer, but it didn’t make a comeback, either.
New cases in pregnant women are still being reported, but the numbers are much lower than a year ago, when the infection was kicking into high gear. For the 2 weeks ending Aug. 22, 106 pregnant women with laboratory evidence of Zika virus infection were reported: 43 in the U.S. states and the District of Columbia, and 63 in the U.S. territories, according to the Centers for Disease Control and Prevention.
The total cases reported for the previous 2-week periods, going back to mid-June, look like this: 102 (June 14-27), 160 (June 28–July 11), 95 (July 12-25), and 103 (July 26–Aug. 8). In the summer of 2016, the 2-week period of Aug. 12-25 produced 375 new reports of Zika-infected pregnant women, the CDC data show.
Zika may not have gone away this summer, but it didn’t make a comeback, either.
New cases in pregnant women are still being reported, but the numbers are much lower than a year ago, when the infection was kicking into high gear. For the 2 weeks ending Aug. 22, 106 pregnant women with laboratory evidence of Zika virus infection were reported: 43 in the U.S. states and the District of Columbia, and 63 in the U.S. territories, according to the Centers for Disease Control and Prevention.
The total cases reported for the previous 2-week periods, going back to mid-June, look like this: 102 (June 14-27), 160 (June 28–July 11), 95 (July 12-25), and 103 (July 26–Aug. 8). In the summer of 2016, the 2-week period of Aug. 12-25 produced 375 new reports of Zika-infected pregnant women, the CDC data show.
Austedo approved for treatment of tardive dyskinesia
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of tardive dyskinesia in adults, according to an announcement from Teva Pharmaceutical Industries.
The agency’s approval of Austedo was based on results from two phase 3 clinical trials in which the drug was shown to be safe and effective at reducing involuntary movements collectively termed tardive dyskinesia, a debilitating and sometimes irreversible movement disorder which affects about 500,000 people in the United States. Austedo was first approved in April 2017 to treat chorea associated with Huntington’s disease.
“Physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition,” Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva, said in the announcement.
The full prescribing information can be viewed here.
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of tardive dyskinesia in adults, according to an announcement from Teva Pharmaceutical Industries.
The agency’s approval of Austedo was based on results from two phase 3 clinical trials in which the drug was shown to be safe and effective at reducing involuntary movements collectively termed tardive dyskinesia, a debilitating and sometimes irreversible movement disorder which affects about 500,000 people in the United States. Austedo was first approved in April 2017 to treat chorea associated with Huntington’s disease.
“Physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition,” Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva, said in the announcement.
The full prescribing information can be viewed here.
The Food and Drug Administration has approved deutetrabenazine (Austedo) for the treatment of tardive dyskinesia in adults, according to an announcement from Teva Pharmaceutical Industries.
The agency’s approval of Austedo was based on results from two phase 3 clinical trials in which the drug was shown to be safe and effective at reducing involuntary movements collectively termed tardive dyskinesia, a debilitating and sometimes irreversible movement disorder which affects about 500,000 people in the United States. Austedo was first approved in April 2017 to treat chorea associated with Huntington’s disease.
“Physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition,” Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva, said in the announcement.
The full prescribing information can be viewed here.
Young adults lead the ranks of recently insured
The uninsured rate for young adults fell 50% from 2010 to 2016, according to the Agency for Healthcare Research and Quality.
In the first quarter of 2010, 30.6% of adults aged 18-29 years did not have health insurance at the time they were interviewed for the National Health Interview Survey. By the last quarter of 2016, that figure was down to 15.4%, a drop of nearly 50%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.
For the total population under age 65 years, the uninsured rate dropped from 17.5% in the first quarter of 2010 to 10.8% in the fourth quarter of 2016, the AHRQ said, for an overall decline of 38%.
The uninsured rate for young adults fell 50% from 2010 to 2016, according to the Agency for Healthcare Research and Quality.
In the first quarter of 2010, 30.6% of adults aged 18-29 years did not have health insurance at the time they were interviewed for the National Health Interview Survey. By the last quarter of 2016, that figure was down to 15.4%, a drop of nearly 50%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.
For the total population under age 65 years, the uninsured rate dropped from 17.5% in the first quarter of 2010 to 10.8% in the fourth quarter of 2016, the AHRQ said, for an overall decline of 38%.
The uninsured rate for young adults fell 50% from 2010 to 2016, according to the Agency for Healthcare Research and Quality.
In the first quarter of 2010, 30.6% of adults aged 18-29 years did not have health insurance at the time they were interviewed for the National Health Interview Survey. By the last quarter of 2016, that figure was down to 15.4%, a drop of nearly 50%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.
For the total population under age 65 years, the uninsured rate dropped from 17.5% in the first quarter of 2010 to 10.8% in the fourth quarter of 2016, the AHRQ said, for an overall decline of 38%.
Extended-release amantadine approved for treatment of dyskinesia in Parkinson’s
An extended-release formulation of amantadine received approval from the Food and Drug Administration on Aug. 24 for the treatment of dyskinesia in patients with Parkinson’s disease. The significant increase in functional time for Parkinson’s disease patients with dyskinesia who took extended-release amantadine was attributable both to a reduction in off-time and to a decrease in troublesome dyskinesia during on-time.
This is the first FDA approval for a drug to treat levodopa therapy-related dyskinesia in patients with Parkinson’s disease, according to an announcement from its manufacturer, Adamas Pharmaceuticals.
The second study also showed clinically relevant and statistically significant results, with a 46% reduction on the UDysRS for those taking ER amantadine, compared with a 16% reduction for those taking placebo.
The oral ER amantadine formulation delivers 274 mg of amantadine once daily at bedtime, allowing sustained high levels of the drug during waking hours, with peak levels delivered during the morning and throughout the day and a trough near bedtime.
When investigators of the two studies analyzed diaries that had been kept by Parkinson’s disease patients, they found that patients in the two studies who were taking ER amantadine experienced a placebo-adjusted reduction in off-time of about 1 hour per day.
Patients in the ER amantadine arm of the first study also had an increase of 3.6 hours per day of functional time, compared with a 0.8-hour increase for patients taking placebo. In the second study, functional time went up by 4.0 hours per day for patients in the ER amantadine arm, compared with an increase of 2.1 hours per day for those on placebo. Functional time was defined as on-time without troublesome dyskinesia.
Adverse reactions to ER amantadine that occurred in more than 10% of patients in the active arms of the study, and which occurred more frequently than in those taking placebo, included hallucinations, falls, orthostatic hypotension, dizziness, peripheral edema, dry mouth, and constipation.
The medication is contraindicated in those with creatinine clearance below 15 mL/min/1.73 m2. Prescribing information advises that amantadine ER be avoided or used with caution in patients with a history of suicidality and depression, hallucinations or psychotic behavior, and orthostatic hypotension or dizziness.
Patients taking ER amantadine may also experience impulsivity and sexual, spending, or gambling urges. Abrupt withdrawal or rapid dose reduction may result in withdrawal-emergent hyperpyrexia or confusion, including delirium, hallucinations, stupor, and slurred speech.
The clinical trials upon which the approval is based were funded by Adamas Pharmaceuticals.
koakes@frontlinemedcom.com
On Twitter @karioakes
An extended-release formulation of amantadine received approval from the Food and Drug Administration on Aug. 24 for the treatment of dyskinesia in patients with Parkinson’s disease. The significant increase in functional time for Parkinson’s disease patients with dyskinesia who took extended-release amantadine was attributable both to a reduction in off-time and to a decrease in troublesome dyskinesia during on-time.
This is the first FDA approval for a drug to treat levodopa therapy-related dyskinesia in patients with Parkinson’s disease, according to an announcement from its manufacturer, Adamas Pharmaceuticals.
The second study also showed clinically relevant and statistically significant results, with a 46% reduction on the UDysRS for those taking ER amantadine, compared with a 16% reduction for those taking placebo.
The oral ER amantadine formulation delivers 274 mg of amantadine once daily at bedtime, allowing sustained high levels of the drug during waking hours, with peak levels delivered during the morning and throughout the day and a trough near bedtime.
When investigators of the two studies analyzed diaries that had been kept by Parkinson’s disease patients, they found that patients in the two studies who were taking ER amantadine experienced a placebo-adjusted reduction in off-time of about 1 hour per day.
Patients in the ER amantadine arm of the first study also had an increase of 3.6 hours per day of functional time, compared with a 0.8-hour increase for patients taking placebo. In the second study, functional time went up by 4.0 hours per day for patients in the ER amantadine arm, compared with an increase of 2.1 hours per day for those on placebo. Functional time was defined as on-time without troublesome dyskinesia.
Adverse reactions to ER amantadine that occurred in more than 10% of patients in the active arms of the study, and which occurred more frequently than in those taking placebo, included hallucinations, falls, orthostatic hypotension, dizziness, peripheral edema, dry mouth, and constipation.
The medication is contraindicated in those with creatinine clearance below 15 mL/min/1.73 m2. Prescribing information advises that amantadine ER be avoided or used with caution in patients with a history of suicidality and depression, hallucinations or psychotic behavior, and orthostatic hypotension or dizziness.
Patients taking ER amantadine may also experience impulsivity and sexual, spending, or gambling urges. Abrupt withdrawal or rapid dose reduction may result in withdrawal-emergent hyperpyrexia or confusion, including delirium, hallucinations, stupor, and slurred speech.
The clinical trials upon which the approval is based were funded by Adamas Pharmaceuticals.
koakes@frontlinemedcom.com
On Twitter @karioakes
An extended-release formulation of amantadine received approval from the Food and Drug Administration on Aug. 24 for the treatment of dyskinesia in patients with Parkinson’s disease. The significant increase in functional time for Parkinson’s disease patients with dyskinesia who took extended-release amantadine was attributable both to a reduction in off-time and to a decrease in troublesome dyskinesia during on-time.
This is the first FDA approval for a drug to treat levodopa therapy-related dyskinesia in patients with Parkinson’s disease, according to an announcement from its manufacturer, Adamas Pharmaceuticals.
The second study also showed clinically relevant and statistically significant results, with a 46% reduction on the UDysRS for those taking ER amantadine, compared with a 16% reduction for those taking placebo.
The oral ER amantadine formulation delivers 274 mg of amantadine once daily at bedtime, allowing sustained high levels of the drug during waking hours, with peak levels delivered during the morning and throughout the day and a trough near bedtime.
When investigators of the two studies analyzed diaries that had been kept by Parkinson’s disease patients, they found that patients in the two studies who were taking ER amantadine experienced a placebo-adjusted reduction in off-time of about 1 hour per day.
Patients in the ER amantadine arm of the first study also had an increase of 3.6 hours per day of functional time, compared with a 0.8-hour increase for patients taking placebo. In the second study, functional time went up by 4.0 hours per day for patients in the ER amantadine arm, compared with an increase of 2.1 hours per day for those on placebo. Functional time was defined as on-time without troublesome dyskinesia.
Adverse reactions to ER amantadine that occurred in more than 10% of patients in the active arms of the study, and which occurred more frequently than in those taking placebo, included hallucinations, falls, orthostatic hypotension, dizziness, peripheral edema, dry mouth, and constipation.
The medication is contraindicated in those with creatinine clearance below 15 mL/min/1.73 m2. Prescribing information advises that amantadine ER be avoided or used with caution in patients with a history of suicidality and depression, hallucinations or psychotic behavior, and orthostatic hypotension or dizziness.
Patients taking ER amantadine may also experience impulsivity and sexual, spending, or gambling urges. Abrupt withdrawal or rapid dose reduction may result in withdrawal-emergent hyperpyrexia or confusion, including delirium, hallucinations, stupor, and slurred speech.
The clinical trials upon which the approval is based were funded by Adamas Pharmaceuticals.
koakes@frontlinemedcom.com
On Twitter @karioakes
Safety issues not that unusual in medical offices
More than a quarter of medical offices report that they are contacted by pharmacies on a daily or weekly basis to clarify or correct prescriptions, according to the Agency for Healthcare Research and Quality.
That safety issue – reported by 27% of outpatient medical offices – was the most common among those included in the Medical Office Survey on Patient Safety Culture from November 2013 to November 2015, the AHRQ said in its annual National Healthcare Quality and Disparities Report. Another 12% of respondents said that such contact with a pharmacy was a monthly occurrence.
Information exchange problems with pharmacies occurred daily or weekly in 12% of offices and monthly in 8%, while the occurrence of medication lists not being updated at the last visit was 11% daily/weekly and 7% monthly. Additionally, 9% of offices reported that results from laboratory or imaging tests were not available when needed on a daily/weekly basis and 10% on a monthly basis, the AHRQ reported.
“Lack of access to care and lack of access to timely and accurate medical information and test results may contribute to patient safety events such as missed or delayed diagnoses, medication errors, failure to order appropriate diagnostic or laboratory tests, incorrect interpretation of tests, and inadequate follow-up on results,” the AHRQ said in the report.
More than a quarter of medical offices report that they are contacted by pharmacies on a daily or weekly basis to clarify or correct prescriptions, according to the Agency for Healthcare Research and Quality.
That safety issue – reported by 27% of outpatient medical offices – was the most common among those included in the Medical Office Survey on Patient Safety Culture from November 2013 to November 2015, the AHRQ said in its annual National Healthcare Quality and Disparities Report. Another 12% of respondents said that such contact with a pharmacy was a monthly occurrence.
Information exchange problems with pharmacies occurred daily or weekly in 12% of offices and monthly in 8%, while the occurrence of medication lists not being updated at the last visit was 11% daily/weekly and 7% monthly. Additionally, 9% of offices reported that results from laboratory or imaging tests were not available when needed on a daily/weekly basis and 10% on a monthly basis, the AHRQ reported.
“Lack of access to care and lack of access to timely and accurate medical information and test results may contribute to patient safety events such as missed or delayed diagnoses, medication errors, failure to order appropriate diagnostic or laboratory tests, incorrect interpretation of tests, and inadequate follow-up on results,” the AHRQ said in the report.
More than a quarter of medical offices report that they are contacted by pharmacies on a daily or weekly basis to clarify or correct prescriptions, according to the Agency for Healthcare Research and Quality.
That safety issue – reported by 27% of outpatient medical offices – was the most common among those included in the Medical Office Survey on Patient Safety Culture from November 2013 to November 2015, the AHRQ said in its annual National Healthcare Quality and Disparities Report. Another 12% of respondents said that such contact with a pharmacy was a monthly occurrence.
Information exchange problems with pharmacies occurred daily or weekly in 12% of offices and monthly in 8%, while the occurrence of medication lists not being updated at the last visit was 11% daily/weekly and 7% monthly. Additionally, 9% of offices reported that results from laboratory or imaging tests were not available when needed on a daily/weekly basis and 10% on a monthly basis, the AHRQ reported.
“Lack of access to care and lack of access to timely and accurate medical information and test results may contribute to patient safety events such as missed or delayed diagnoses, medication errors, failure to order appropriate diagnostic or laboratory tests, incorrect interpretation of tests, and inadequate follow-up on results,” the AHRQ said in the report.
Standardized infection ratio for CLABSI almost halved since 2009
The standardized infection ratio (SIR) for central line–associated bloodstream infections dropped 42% from 2009 to 2014, according to the Agency for Healthcare Research and Quality.
For acute care hospitalizations, the SIR for central line–associated bloodstream infections (CLABSIs) fell from 0.854 in 2009 to 0.495 in 2014. Over that same time period, the SIR for surgical site infections involving Surgical Care Improvement Project procedures decreased from 0.981 to 0.827 – almost 16%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.
From 2010 to 2014, the SIR for catheter-associated urinary tract infections increased 6.7% from 0.937 to 1.000, but that change was not significant. For laboratory-identified hospital-onset Clostridium difficile infection, the SIR dropped from 0.963 to 0.924 – about 4% – from 2012 to 2014, the AHRQ reported using data from the National Center for Emerging and Zoonotic Infectious Diseases and the National Healthcare Safety Network.
The standardized infection ratio (SIR) for central line–associated bloodstream infections dropped 42% from 2009 to 2014, according to the Agency for Healthcare Research and Quality.
For acute care hospitalizations, the SIR for central line–associated bloodstream infections (CLABSIs) fell from 0.854 in 2009 to 0.495 in 2014. Over that same time period, the SIR for surgical site infections involving Surgical Care Improvement Project procedures decreased from 0.981 to 0.827 – almost 16%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.
From 2010 to 2014, the SIR for catheter-associated urinary tract infections increased 6.7% from 0.937 to 1.000, but that change was not significant. For laboratory-identified hospital-onset Clostridium difficile infection, the SIR dropped from 0.963 to 0.924 – about 4% – from 2012 to 2014, the AHRQ reported using data from the National Center for Emerging and Zoonotic Infectious Diseases and the National Healthcare Safety Network.
The standardized infection ratio (SIR) for central line–associated bloodstream infections dropped 42% from 2009 to 2014, according to the Agency for Healthcare Research and Quality.
For acute care hospitalizations, the SIR for central line–associated bloodstream infections (CLABSIs) fell from 0.854 in 2009 to 0.495 in 2014. Over that same time period, the SIR for surgical site infections involving Surgical Care Improvement Project procedures decreased from 0.981 to 0.827 – almost 16%, the AHRQ said in its annual National Healthcare Quality and Disparities Report.
From 2010 to 2014, the SIR for catheter-associated urinary tract infections increased 6.7% from 0.937 to 1.000, but that change was not significant. For laboratory-identified hospital-onset Clostridium difficile infection, the SIR dropped from 0.963 to 0.924 – about 4% – from 2012 to 2014, the AHRQ reported using data from the National Center for Emerging and Zoonotic Infectious Diseases and the National Healthcare Safety Network.
Safety alert for intragastric balloon systems
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
Safety alert for intragastric balloon systems
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
FDA approves first spironolactone oral suspension
The Food and Drug Administration has approved CaroSpir, the first oral suspension form of spironolactone, the aldosterone antagonist that was first approved in 1960, according to an announcement from CMP Pharma.
CaroSpir is intended for the treatment of New York Heart Association class III-IV heart failure and reduced ejection fraction, usually in combination with other treatments. CaroSpir is also indicated as an add-on medication for the treatment of hypertension, and for the treatment of edema in cirrhotic patients who have not adequately responded to fluid and sodium restriction.
“CaroSpir provides a stable, ready to use, and consistent liquid treatment option for adult patients. Up until now, these patients have been prescribed a pharmacy-compounded liquid form of spironolactone. The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians,” Gerald Sakowski, CEO at CMP Pharma, said in the press release.
Find the full press release on the CMP Pharma website.
The Food and Drug Administration has approved CaroSpir, the first oral suspension form of spironolactone, the aldosterone antagonist that was first approved in 1960, according to an announcement from CMP Pharma.
CaroSpir is intended for the treatment of New York Heart Association class III-IV heart failure and reduced ejection fraction, usually in combination with other treatments. CaroSpir is also indicated as an add-on medication for the treatment of hypertension, and for the treatment of edema in cirrhotic patients who have not adequately responded to fluid and sodium restriction.
“CaroSpir provides a stable, ready to use, and consistent liquid treatment option for adult patients. Up until now, these patients have been prescribed a pharmacy-compounded liquid form of spironolactone. The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians,” Gerald Sakowski, CEO at CMP Pharma, said in the press release.
Find the full press release on the CMP Pharma website.
The Food and Drug Administration has approved CaroSpir, the first oral suspension form of spironolactone, the aldosterone antagonist that was first approved in 1960, according to an announcement from CMP Pharma.
CaroSpir is intended for the treatment of New York Heart Association class III-IV heart failure and reduced ejection fraction, usually in combination with other treatments. CaroSpir is also indicated as an add-on medication for the treatment of hypertension, and for the treatment of edema in cirrhotic patients who have not adequately responded to fluid and sodium restriction.
“CaroSpir provides a stable, ready to use, and consistent liquid treatment option for adult patients. Up until now, these patients have been prescribed a pharmacy-compounded liquid form of spironolactone. The dosing inconsistencies of compounded liquids have long been a persistent challenge for physicians,” Gerald Sakowski, CEO at CMP Pharma, said in the press release.
Find the full press release on the CMP Pharma website.
FDA approves faster, pangenotypic cure for hep C virus
The first pangenotypic treatment for the hepatitis C virus, which also shaves 4 weeks off current regimens, has just been approved by the Food and Drug Administration.
Manufactured by AbbVie, glecaprevir/pibrentasvir (Mavyret) combines a nonstructural protein 3/4A protease inhibitor with a next-generation NS5A protein inhibitor for a once-daily, ribavirin-free treatment for adults with any of the major genotypes of chronic hepatitis C virus (HCV) infection.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., said in a statement.
The 8-week regimen is indicated in patients without cirrhosis or with compensated cirrhosis, who are new to treatment, and those with limited treatment options, such as patients with chronic kidney disease, including those on dialysis. The intervention also is indicated in adults with HCV genotype 1 who have been treated with either of the drugs in the combination, but not both. Glecaprevir/pibrentasvir is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in those taking the drugs atazanavir and rifampin.
The safety and efficacy of the treatment were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. In the clinical trials, between 92% and 100% of patients treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks had no detectable serum levels of the virus 12 weeks after finishing treatment. The most commonly reported adverse reactions were headache, fatigue, and nausea.
The FDA directs health care professionals to test all patients for current or prior hepatitis B virus (HBV) infection prior to starting this direct-acting antiviral drug combination since HBV reactivation has been reported in adult patients coinfected with both viruses who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy.
The AGA HCV Clinical Service Line provides tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
The first pangenotypic treatment for the hepatitis C virus, which also shaves 4 weeks off current regimens, has just been approved by the Food and Drug Administration.
Manufactured by AbbVie, glecaprevir/pibrentasvir (Mavyret) combines a nonstructural protein 3/4A protease inhibitor with a next-generation NS5A protein inhibitor for a once-daily, ribavirin-free treatment for adults with any of the major genotypes of chronic hepatitis C virus (HCV) infection.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., said in a statement.
The 8-week regimen is indicated in patients without cirrhosis or with compensated cirrhosis, who are new to treatment, and those with limited treatment options, such as patients with chronic kidney disease, including those on dialysis. The intervention also is indicated in adults with HCV genotype 1 who have been treated with either of the drugs in the combination, but not both. Glecaprevir/pibrentasvir is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in those taking the drugs atazanavir and rifampin.
The safety and efficacy of the treatment were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. In the clinical trials, between 92% and 100% of patients treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks had no detectable serum levels of the virus 12 weeks after finishing treatment. The most commonly reported adverse reactions were headache, fatigue, and nausea.
The FDA directs health care professionals to test all patients for current or prior hepatitis B virus (HBV) infection prior to starting this direct-acting antiviral drug combination since HBV reactivation has been reported in adult patients coinfected with both viruses who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy.
The AGA HCV Clinical Service Line provides tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
The first pangenotypic treatment for the hepatitis C virus, which also shaves 4 weeks off current regimens, has just been approved by the Food and Drug Administration.
Manufactured by AbbVie, glecaprevir/pibrentasvir (Mavyret) combines a nonstructural protein 3/4A protease inhibitor with a next-generation NS5A protein inhibitor for a once-daily, ribavirin-free treatment for adults with any of the major genotypes of chronic hepatitis C virus (HCV) infection.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., said in a statement.
The 8-week regimen is indicated in patients without cirrhosis or with compensated cirrhosis, who are new to treatment, and those with limited treatment options, such as patients with chronic kidney disease, including those on dialysis. The intervention also is indicated in adults with HCV genotype 1 who have been treated with either of the drugs in the combination, but not both. Glecaprevir/pibrentasvir is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in those taking the drugs atazanavir and rifampin.
The safety and efficacy of the treatment were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. In the clinical trials, between 92% and 100% of patients treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks had no detectable serum levels of the virus 12 weeks after finishing treatment. The most commonly reported adverse reactions were headache, fatigue, and nausea.
The FDA directs health care professionals to test all patients for current or prior hepatitis B virus (HBV) infection prior to starting this direct-acting antiviral drug combination since HBV reactivation has been reported in adult patients coinfected with both viruses who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy.
The AGA HCV Clinical Service Line provides tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c