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Christopher Palmer has been an associate editor at MDedge News since 2017. When he's not tidying grammar, he writes short pieces about breaking FDA announcements and approvals, as well as journal articles. He proudly holds a BA in English and philosophy. Follow him on Twitter @cmacmpalm.
Refrigerator-stable varicella vaccine held safe and effective
profiles when administered concomitantly with MMR vaccine, according to a study in Vaccine.
In this double-blind, controlled, multicenter study, Keith S. Reisinger of Primary Physicians Research, Pittsburgh, and his colleagues randomized 958 subjects aged 12-23 months to receive either 8,000 plaque-forming units (PFU) refrigerated vaccine (n = 320; group 1), 25,000 PFU refrigerated vaccine (n = 315; group 2), or 10,000 PFU frozen vaccine (n = 323; group 3), and subjects in all three groups also received MMR vaccine. The primary endpoint for immunogenicity was percentage of subjects with at least 5 titers of varicella antibody according to glycoprotein enzyme-linked immunosorbent assay among the three groups 6 weeks post vaccination; the primary safety endpoint was incidences of vaccine-related adverse events during days 0-42 post vaccination.
The percentages of subjects meeting the primary endpoint for immunogenicity were comparable among the groups, at 93%, 94%, and 95% for groups 1, 2, and 3, respectively. Results for the safety endpoints also were similar among the groups; for example, rates of injection-site adverse events or vaccine-related injection-site adverse events were 44%, 40%, and 43%, with no statistically significant between-group differences.
The study authors noted that one of the problems with having only frozen formulations is how that limits availability in parts of the world where only refrigeration of 2°C–8°C is available. “Use of a refrigerator-stable formulation of varicella vaccine will allow for increased availability of the product throughout the world and may help to increase vaccination rates against varicella,” they concluded.
Strengths of the study included its head-to-head design. Limitations included how adverse events were based on parental reporting.
Some authors reported relationships, including employment, with Merck & Co, which developed the vaccine in this study and funded the study.
SOURCE: Reisinger KS et al. Vaccine. 2018 Aug 23. doi: 10.1016/j.vaccine.2018.01.089.
profiles when administered concomitantly with MMR vaccine, according to a study in Vaccine.
In this double-blind, controlled, multicenter study, Keith S. Reisinger of Primary Physicians Research, Pittsburgh, and his colleagues randomized 958 subjects aged 12-23 months to receive either 8,000 plaque-forming units (PFU) refrigerated vaccine (n = 320; group 1), 25,000 PFU refrigerated vaccine (n = 315; group 2), or 10,000 PFU frozen vaccine (n = 323; group 3), and subjects in all three groups also received MMR vaccine. The primary endpoint for immunogenicity was percentage of subjects with at least 5 titers of varicella antibody according to glycoprotein enzyme-linked immunosorbent assay among the three groups 6 weeks post vaccination; the primary safety endpoint was incidences of vaccine-related adverse events during days 0-42 post vaccination.
The percentages of subjects meeting the primary endpoint for immunogenicity were comparable among the groups, at 93%, 94%, and 95% for groups 1, 2, and 3, respectively. Results for the safety endpoints also were similar among the groups; for example, rates of injection-site adverse events or vaccine-related injection-site adverse events were 44%, 40%, and 43%, with no statistically significant between-group differences.
The study authors noted that one of the problems with having only frozen formulations is how that limits availability in parts of the world where only refrigeration of 2°C–8°C is available. “Use of a refrigerator-stable formulation of varicella vaccine will allow for increased availability of the product throughout the world and may help to increase vaccination rates against varicella,” they concluded.
Strengths of the study included its head-to-head design. Limitations included how adverse events were based on parental reporting.
Some authors reported relationships, including employment, with Merck & Co, which developed the vaccine in this study and funded the study.
SOURCE: Reisinger KS et al. Vaccine. 2018 Aug 23. doi: 10.1016/j.vaccine.2018.01.089.
profiles when administered concomitantly with MMR vaccine, according to a study in Vaccine.
In this double-blind, controlled, multicenter study, Keith S. Reisinger of Primary Physicians Research, Pittsburgh, and his colleagues randomized 958 subjects aged 12-23 months to receive either 8,000 plaque-forming units (PFU) refrigerated vaccine (n = 320; group 1), 25,000 PFU refrigerated vaccine (n = 315; group 2), or 10,000 PFU frozen vaccine (n = 323; group 3), and subjects in all three groups also received MMR vaccine. The primary endpoint for immunogenicity was percentage of subjects with at least 5 titers of varicella antibody according to glycoprotein enzyme-linked immunosorbent assay among the three groups 6 weeks post vaccination; the primary safety endpoint was incidences of vaccine-related adverse events during days 0-42 post vaccination.
The percentages of subjects meeting the primary endpoint for immunogenicity were comparable among the groups, at 93%, 94%, and 95% for groups 1, 2, and 3, respectively. Results for the safety endpoints also were similar among the groups; for example, rates of injection-site adverse events or vaccine-related injection-site adverse events were 44%, 40%, and 43%, with no statistically significant between-group differences.
The study authors noted that one of the problems with having only frozen formulations is how that limits availability in parts of the world where only refrigeration of 2°C–8°C is available. “Use of a refrigerator-stable formulation of varicella vaccine will allow for increased availability of the product throughout the world and may help to increase vaccination rates against varicella,” they concluded.
Strengths of the study included its head-to-head design. Limitations included how adverse events were based on parental reporting.
Some authors reported relationships, including employment, with Merck & Co, which developed the vaccine in this study and funded the study.
SOURCE: Reisinger KS et al. Vaccine. 2018 Aug 23. doi: 10.1016/j.vaccine.2018.01.089.
FDA: Faulty hematology analyzers face class I recall
The Food and Drug Administration is alerting laboratories and providers to a class I recall on Beckman Coulter hematology analyzers because of the potential for inaccurate platelet count results.
A class I recall indicates reasonable probability of serious adverse health consequences or death associated with use, according to the FDA.
The recall is related to the devices’ platelet analyzing function; among other uses, these devices help assess patients fitness for surgery, so a faulty reading on platelet counts could result in increased risk for life-threatening bleeding during a procedure in patients who have unidentified severe thrombocytopenia, according to a statement from the agency.
“Because this may cause serious injury, or even death, to a patient, we are urging health care professionals to be aware of the potential for inaccurate diagnostic results with these analyzers and to take appropriate actions including the use of alternative diagnostic testing or confirming analyzer results with manual scanning or estimate of platelets,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.
The recall applies to the UniCel DxH 800 Coulter Cellular Analysis System, UniCel DxH 600 Coulter Cellular Analysis System, and UniCel DxH 900 Coulter Cellular Analysis System. The faulty devices were first identified in 2018, and the manufacturer released an urgent medical device correction letter at that time. The company has more recently released a software patch for the devices, but the FDA has not yet assessed whether it resolves the problem. The agency has released detailed actions and recommendations related to these devices.
At this time, the FDA is unaware of any serious adverse events that have been directly linked to these devices, but the agency recommends that any events be reported through its MedWatch reporting system.
The Food and Drug Administration is alerting laboratories and providers to a class I recall on Beckman Coulter hematology analyzers because of the potential for inaccurate platelet count results.
A class I recall indicates reasonable probability of serious adverse health consequences or death associated with use, according to the FDA.
The recall is related to the devices’ platelet analyzing function; among other uses, these devices help assess patients fitness for surgery, so a faulty reading on platelet counts could result in increased risk for life-threatening bleeding during a procedure in patients who have unidentified severe thrombocytopenia, according to a statement from the agency.
“Because this may cause serious injury, or even death, to a patient, we are urging health care professionals to be aware of the potential for inaccurate diagnostic results with these analyzers and to take appropriate actions including the use of alternative diagnostic testing or confirming analyzer results with manual scanning or estimate of platelets,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.
The recall applies to the UniCel DxH 800 Coulter Cellular Analysis System, UniCel DxH 600 Coulter Cellular Analysis System, and UniCel DxH 900 Coulter Cellular Analysis System. The faulty devices were first identified in 2018, and the manufacturer released an urgent medical device correction letter at that time. The company has more recently released a software patch for the devices, but the FDA has not yet assessed whether it resolves the problem. The agency has released detailed actions and recommendations related to these devices.
At this time, the FDA is unaware of any serious adverse events that have been directly linked to these devices, but the agency recommends that any events be reported through its MedWatch reporting system.
The Food and Drug Administration is alerting laboratories and providers to a class I recall on Beckman Coulter hematology analyzers because of the potential for inaccurate platelet count results.
A class I recall indicates reasonable probability of serious adverse health consequences or death associated with use, according to the FDA.
The recall is related to the devices’ platelet analyzing function; among other uses, these devices help assess patients fitness for surgery, so a faulty reading on platelet counts could result in increased risk for life-threatening bleeding during a procedure in patients who have unidentified severe thrombocytopenia, according to a statement from the agency.
“Because this may cause serious injury, or even death, to a patient, we are urging health care professionals to be aware of the potential for inaccurate diagnostic results with these analyzers and to take appropriate actions including the use of alternative diagnostic testing or confirming analyzer results with manual scanning or estimate of platelets,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.
The recall applies to the UniCel DxH 800 Coulter Cellular Analysis System, UniCel DxH 600 Coulter Cellular Analysis System, and UniCel DxH 900 Coulter Cellular Analysis System. The faulty devices were first identified in 2018, and the manufacturer released an urgent medical device correction letter at that time. The company has more recently released a software patch for the devices, but the FDA has not yet assessed whether it resolves the problem. The agency has released detailed actions and recommendations related to these devices.
At this time, the FDA is unaware of any serious adverse events that have been directly linked to these devices, but the agency recommends that any events be reported through its MedWatch reporting system.
FDA updates warning about Impella RP System
The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.
The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.
This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.
The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”
The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.
More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.
The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.
This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.
The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”
The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.
More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.
The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.
This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.
The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”
The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.
More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
FDA issues warning about use of unauthorized diabetes devices
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
This safety communication applies to continuous glucose monitors, insulin pumps, and automated insulin-dosing systems and is intended for both patients who manage their diabetes with any of various devices and the health care providers who treat and manage those patients.
The agency’s concerns were underscored by a recent report it received about a patient who used a combination of unauthorized devices and who needed medical intervention as a result.
“Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended, or when [patients] use devices not authorized for sale in the [United States],” Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health, said in a news release. “[This] warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”
The release noted that the agency reviews some of the diabetes management devices as an entity, or system, or as being compatible with other approved components, such as integrated continuous glucose-monitoring systems. “This is known as interoperability, which allows patients to safely tailor their diabetes management to their individual preferences by choosing devices that are authorized by the FDA to work together,” it said.
However, the agency said it is aware that some manufacturers are illegally marketing devices that it hasn’t reviewed for safety and effectiveness and that some patients combine devices or components that are not intended for use with each other in an effort to cut costs or because of personal preferences. When patients do that, it introduces new risks that “could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to risks requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis, and death,” it warned.
The agency said it realized that patients with chronic conditions such as diabetes preferred having a range of options so that they could tailor their treatment and management to their specific needs, but that it was important that they were fully aware of the risks of doing so.
It recommended that patients speak to their doctor about their device and component needs and use only those that the FDA has reviewed for safety and effectiveness. In addition, any concerns about the cost or availability of approved systems should be taken up with the treating doctor and insurance provider, who can advise on coverage and acceptable, alternative options.
Any adverse events should be reported to the agency through its MedWatch reporting system.
More information about safety in diabetes management devices and components is available at safety communication and the agency’s news release.
Benzodiazepines nearly double the odds of spontaneous abortion
Early-pregnancy spontaneous abortion was almost twice as common among women who used benzodiazepines, according to 17 years’ worth of data from the Quebec Pregnancy Cohort, which prospectively collects data on all pregnancies of women covered by the Quebec Public Prescription Drug Insurance Plan.
The findings suggest the need for caution before prescribing benzodiazepines to treat insomnia and mood or anxiety disorders in early pregnancy. “Alternative nonpharmacologic treatments exist and are recommended, but if benzodiazepines are needed, they should be prescribed for short durations,” wrote Odile Sheehy, MSc, of the Research Center at Centre Hospitalier Universitaire Sainte-Justine, Montreal, and colleagues, in a study published in JAMA Psychiatry.
The researchers evaluated data from 27,149 study-eligible women who had a spontaneous abortion after 6 weeks’ gestation and before 20 weeks’ gestation between Jan. 1, 1998, and Dec. 31, 2015. Among filled prescriptions, at least one benzodiazepine was used by 375 (1.4%) of the women. These women were matched with five randomly selected control pregnancies per case. The data were adjusted for diagnoses of mood and anxiety disorders and insomnia as well as for several documented proxies of these diseases, such as concomitant exposure to antidepressants or antipsychotics, visits to a psychiatrist, comorbidities, and hospitalizations.
The investigators found an adjusted odds ratio (aOR) of 1.85 (95% confidence interval, 1.61-2.12) for benzodiazepine use. The odds of spontaneous abortion was increased with use of all types of benzodiazepines evaluated in the study, with aORs as low as 1.13 and as high as 3.43, as well as similar aORs between long-acting and short-acting benzodiazepines (1.81 vs. 1.73, respectively).
While the information is accurate regarding filled prescriptions, the findings might not apply to women with private drug insurance as the study included only women in a prescription drug program, the researchers said. They noted, however, that pregnant women receiving medication insurance from Quebec’s public system have characteristics and comorbidities similar to those of women who are covered by private medication insurance.
One author reported being a consultant for plaintiffs in litigations involving antidepressants and birth defects. No other disclosures were reported.
SOURCE: Sheehy O et al. JAMA Psychiatry. 2019 May 15. doi: 10.1001/jamapsychiatry.2019.0963.
Early-pregnancy spontaneous abortion was almost twice as common among women who used benzodiazepines, according to 17 years’ worth of data from the Quebec Pregnancy Cohort, which prospectively collects data on all pregnancies of women covered by the Quebec Public Prescription Drug Insurance Plan.
The findings suggest the need for caution before prescribing benzodiazepines to treat insomnia and mood or anxiety disorders in early pregnancy. “Alternative nonpharmacologic treatments exist and are recommended, but if benzodiazepines are needed, they should be prescribed for short durations,” wrote Odile Sheehy, MSc, of the Research Center at Centre Hospitalier Universitaire Sainte-Justine, Montreal, and colleagues, in a study published in JAMA Psychiatry.
The researchers evaluated data from 27,149 study-eligible women who had a spontaneous abortion after 6 weeks’ gestation and before 20 weeks’ gestation between Jan. 1, 1998, and Dec. 31, 2015. Among filled prescriptions, at least one benzodiazepine was used by 375 (1.4%) of the women. These women were matched with five randomly selected control pregnancies per case. The data were adjusted for diagnoses of mood and anxiety disorders and insomnia as well as for several documented proxies of these diseases, such as concomitant exposure to antidepressants or antipsychotics, visits to a psychiatrist, comorbidities, and hospitalizations.
The investigators found an adjusted odds ratio (aOR) of 1.85 (95% confidence interval, 1.61-2.12) for benzodiazepine use. The odds of spontaneous abortion was increased with use of all types of benzodiazepines evaluated in the study, with aORs as low as 1.13 and as high as 3.43, as well as similar aORs between long-acting and short-acting benzodiazepines (1.81 vs. 1.73, respectively).
While the information is accurate regarding filled prescriptions, the findings might not apply to women with private drug insurance as the study included only women in a prescription drug program, the researchers said. They noted, however, that pregnant women receiving medication insurance from Quebec’s public system have characteristics and comorbidities similar to those of women who are covered by private medication insurance.
One author reported being a consultant for plaintiffs in litigations involving antidepressants and birth defects. No other disclosures were reported.
SOURCE: Sheehy O et al. JAMA Psychiatry. 2019 May 15. doi: 10.1001/jamapsychiatry.2019.0963.
Early-pregnancy spontaneous abortion was almost twice as common among women who used benzodiazepines, according to 17 years’ worth of data from the Quebec Pregnancy Cohort, which prospectively collects data on all pregnancies of women covered by the Quebec Public Prescription Drug Insurance Plan.
The findings suggest the need for caution before prescribing benzodiazepines to treat insomnia and mood or anxiety disorders in early pregnancy. “Alternative nonpharmacologic treatments exist and are recommended, but if benzodiazepines are needed, they should be prescribed for short durations,” wrote Odile Sheehy, MSc, of the Research Center at Centre Hospitalier Universitaire Sainte-Justine, Montreal, and colleagues, in a study published in JAMA Psychiatry.
The researchers evaluated data from 27,149 study-eligible women who had a spontaneous abortion after 6 weeks’ gestation and before 20 weeks’ gestation between Jan. 1, 1998, and Dec. 31, 2015. Among filled prescriptions, at least one benzodiazepine was used by 375 (1.4%) of the women. These women were matched with five randomly selected control pregnancies per case. The data were adjusted for diagnoses of mood and anxiety disorders and insomnia as well as for several documented proxies of these diseases, such as concomitant exposure to antidepressants or antipsychotics, visits to a psychiatrist, comorbidities, and hospitalizations.
The investigators found an adjusted odds ratio (aOR) of 1.85 (95% confidence interval, 1.61-2.12) for benzodiazepine use. The odds of spontaneous abortion was increased with use of all types of benzodiazepines evaluated in the study, with aORs as low as 1.13 and as high as 3.43, as well as similar aORs between long-acting and short-acting benzodiazepines (1.81 vs. 1.73, respectively).
While the information is accurate regarding filled prescriptions, the findings might not apply to women with private drug insurance as the study included only women in a prescription drug program, the researchers said. They noted, however, that pregnant women receiving medication insurance from Quebec’s public system have characteristics and comorbidities similar to those of women who are covered by private medication insurance.
One author reported being a consultant for plaintiffs in litigations involving antidepressants and birth defects. No other disclosures were reported.
SOURCE: Sheehy O et al. JAMA Psychiatry. 2019 May 15. doi: 10.1001/jamapsychiatry.2019.0963.
FROM JAMA PSYCHIATRY
Peanut contamination risk prompts Promacta recall
Novartis has recalled three lots of 12.5-mg eltrombopag (Promacta) for oral suspension following discovery of possible contamination with peanut flour at a third-party manufacturing site.
Tablets at doses of 12.5 mg, 25 mg, 50 mg, and 75 mg are unaffected by this recall because they are not manufactured in the same facility. The recalled lots of medication were distributed between January and April 2019, but so far, Novartis has not received any reports of adverse events related to the recall.
Oral suspension of eltrombopag is indicated for certain patients with chronic immune thrombocytopenia, hepatitis C–associated thrombocytopenia, and severe aplastic anemia.
More information on the recalled lots and instructions on how to return the product can be found in the full announcement, which is also available through the Food and Drug Administration website.
Novartis has recalled three lots of 12.5-mg eltrombopag (Promacta) for oral suspension following discovery of possible contamination with peanut flour at a third-party manufacturing site.
Tablets at doses of 12.5 mg, 25 mg, 50 mg, and 75 mg are unaffected by this recall because they are not manufactured in the same facility. The recalled lots of medication were distributed between January and April 2019, but so far, Novartis has not received any reports of adverse events related to the recall.
Oral suspension of eltrombopag is indicated for certain patients with chronic immune thrombocytopenia, hepatitis C–associated thrombocytopenia, and severe aplastic anemia.
More information on the recalled lots and instructions on how to return the product can be found in the full announcement, which is also available through the Food and Drug Administration website.
Novartis has recalled three lots of 12.5-mg eltrombopag (Promacta) for oral suspension following discovery of possible contamination with peanut flour at a third-party manufacturing site.
Tablets at doses of 12.5 mg, 25 mg, 50 mg, and 75 mg are unaffected by this recall because they are not manufactured in the same facility. The recalled lots of medication were distributed between January and April 2019, but so far, Novartis has not received any reports of adverse events related to the recall.
Oral suspension of eltrombopag is indicated for certain patients with chronic immune thrombocytopenia, hepatitis C–associated thrombocytopenia, and severe aplastic anemia.
More information on the recalled lots and instructions on how to return the product can be found in the full announcement, which is also available through the Food and Drug Administration website.
Comorbid depression worsens many pediatric hospital outcomes
according to a study in the Journal of Affective Disorders.
The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.
This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.
One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.
The study did not receive funding, and the authors declared there are no conflicts of interest.
SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.
according to a study in the Journal of Affective Disorders.
The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.
This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.
One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.
The study did not receive funding, and the authors declared there are no conflicts of interest.
SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.
according to a study in the Journal of Affective Disorders.
The investigators led by Mayowa Olusunmade, MD, MPH, of New Jersey Medical School, Newark, found that, compared with those among nondepressed pediatric patients, hospitalization costs were $2,961 higher (P less than .001), length of stay was 0.89 days longer (P less than .001), and odds of death as an outcome while hospitalized was 1.77 times higher (P = .013) among depressed pediatric patients. On the other hand, depressed patients had 0.3 fewer procedures (P less than .001) than nondepressed patients.
This analysis is based on 17,073 pairs of patients with and without depression that were created through one-to-one propensity score matching. The investigators drew these pairs from an estimated 937,971 patients in the Kids’ Inpatient Database for 2012 who were identified as being aged 6 years and older and having any of the 10 of the most common diagnoses other than affective disorders. The investigators then determined which children among those identified had comorbid depression (2.9%) and which did not (97.1%) to create the propensity score–matched pairs.
One limitation in this study is that the mean age was 17.5 years because depression diagnosis is more atypical among younger patients such that adolescents were disproportionately represented.
The study did not receive funding, and the authors declared there are no conflicts of interest.
SOURCE: Olusunmade M et al. J Affect Disord. 2019 Mar 27. doi: 10.1016/j.jad.2019.03.073.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Insomnia meds get boxed warning from FDA
The Food and Drug Administration will now require that certain
Complex sleep behaviors have been seen with these medications in patients with and without a history of them, at low doses, and even after one dose of the medication. They’ve also been observed with and without concomitant use of alcohol or other CNS depressants.
Health care professionals should advise patients about these risks, even though they are rare. Patients should contact health care professionals if they either experience a complex sleep behavior while not fully awake on one of these medicines or have performed activities they don’t remember while taking the medicine.
More information about these risks and the safety warnings can be found in the FDA’s safety announcement. Other information is also available in a press announcement from the agency.
The Food and Drug Administration will now require that certain
Complex sleep behaviors have been seen with these medications in patients with and without a history of them, at low doses, and even after one dose of the medication. They’ve also been observed with and without concomitant use of alcohol or other CNS depressants.
Health care professionals should advise patients about these risks, even though they are rare. Patients should contact health care professionals if they either experience a complex sleep behavior while not fully awake on one of these medicines or have performed activities they don’t remember while taking the medicine.
More information about these risks and the safety warnings can be found in the FDA’s safety announcement. Other information is also available in a press announcement from the agency.
The Food and Drug Administration will now require that certain
Complex sleep behaviors have been seen with these medications in patients with and without a history of them, at low doses, and even after one dose of the medication. They’ve also been observed with and without concomitant use of alcohol or other CNS depressants.
Health care professionals should advise patients about these risks, even though they are rare. Patients should contact health care professionals if they either experience a complex sleep behavior while not fully awake on one of these medicines or have performed activities they don’t remember while taking the medicine.
More information about these risks and the safety warnings can be found in the FDA’s safety announcement. Other information is also available in a press announcement from the agency.
Mavyret approved for children with any HCV genotype
The Food and Drug Administration has approved glecaprevir/pibrentasvir tablets (Mavyret) for treating any of six identified genotypes of hepatitis C virus in children ages 12-17 years.
The agency noted in its press announcement that, Dosing information now will be provided for patients aged 12 years and older or weighing at least 99 lbs, without cirrhosis or who have compensated cirrhosis. It is not recommended for patients with moderate cirrhosis, and it is contraindicated in patients with severe cirrhosis, as well as patients taking atazanavir and rifampin.
In clinical trials of 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with only mild cirrhosis, results at 12 weeks after 8 or 16 weeks’ treatment suggested patients’ infections had been cured – 100% had no virus detected in their blood. Adverse reactions observed were consistent with those previously observed in adults during clinical trials.
The most common reactions were headache and fatigue. Hepatitis B virus reactivation has been reported in coinfected adults during or after treatment with direct-acting antivirals, and in those who were not receiving HBV antiviral treatment. Full prescribing information can be found on the FDA website, and more information about this approval can be found in the agency’s announcement.
The Food and Drug Administration has approved glecaprevir/pibrentasvir tablets (Mavyret) for treating any of six identified genotypes of hepatitis C virus in children ages 12-17 years.
The agency noted in its press announcement that, Dosing information now will be provided for patients aged 12 years and older or weighing at least 99 lbs, without cirrhosis or who have compensated cirrhosis. It is not recommended for patients with moderate cirrhosis, and it is contraindicated in patients with severe cirrhosis, as well as patients taking atazanavir and rifampin.
In clinical trials of 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with only mild cirrhosis, results at 12 weeks after 8 or 16 weeks’ treatment suggested patients’ infections had been cured – 100% had no virus detected in their blood. Adverse reactions observed were consistent with those previously observed in adults during clinical trials.
The most common reactions were headache and fatigue. Hepatitis B virus reactivation has been reported in coinfected adults during or after treatment with direct-acting antivirals, and in those who were not receiving HBV antiviral treatment. Full prescribing information can be found on the FDA website, and more information about this approval can be found in the agency’s announcement.
The Food and Drug Administration has approved glecaprevir/pibrentasvir tablets (Mavyret) for treating any of six identified genotypes of hepatitis C virus in children ages 12-17 years.
The agency noted in its press announcement that, Dosing information now will be provided for patients aged 12 years and older or weighing at least 99 lbs, without cirrhosis or who have compensated cirrhosis. It is not recommended for patients with moderate cirrhosis, and it is contraindicated in patients with severe cirrhosis, as well as patients taking atazanavir and rifampin.
In clinical trials of 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with only mild cirrhosis, results at 12 weeks after 8 or 16 weeks’ treatment suggested patients’ infections had been cured – 100% had no virus detected in their blood. Adverse reactions observed were consistent with those previously observed in adults during clinical trials.
The most common reactions were headache and fatigue. Hepatitis B virus reactivation has been reported in coinfected adults during or after treatment with direct-acting antivirals, and in those who were not receiving HBV antiviral treatment. Full prescribing information can be found on the FDA website, and more information about this approval can be found in the agency’s announcement.
Benlysta approved for children with SLE
The B-lymphocyte stimulator–inhibitor called Benlysta already is approved for use in adults alongside standard therapy for SLE, and this approval marks the first such treatment available for children. Although there are regulatory submissions for use of this drug among children elsewhere, the United States is the first to approve its use among this age group, according to a press release from GSK. According to an FDA press announcement, the agency expedited the review and approval because belimumab could fulfill an unmet need.
The approval is based on a 1-year postapproval commitment study, which assessed efficacy, safety, and pharmacokinetics of 10 mg/kg belimumab plus standard therapy versus placebo plus standard therapy among children with SLE aged 5-11 years (n = 13) and those aged 12-17 years (n = 80). Although the study was not fully powered because of the rarity of the disease in this age group, it did find numerically higher SLE responder index response rates over 1 year among children treated with belimumab plus standard therapy (53%) than in those treated with placebo and standard therapy (44%).
Adverse reactions seen among this age group were consistent with those seen in adults, including nausea, diarrhea, pyrexia, nasopharyngitis, and bronchitis. The most common serious adverse reactions were serious infections. Belimumab has not been studied in combination with certain other drugs, such as other biologics or cyclophosphamide; therefore, combining it with such treatments is not recommended. Acute hypersensitivity reactions – including anaphylaxis and death – have been observed, even among patients who had previously tolerated belimumab.
Infusion reactions were common, so pretreat patients with an antihistamine. Also, do not administer the drug with live vaccines, the FDA noted.
More information can be found in the press announcement on the FDA website.
The B-lymphocyte stimulator–inhibitor called Benlysta already is approved for use in adults alongside standard therapy for SLE, and this approval marks the first such treatment available for children. Although there are regulatory submissions for use of this drug among children elsewhere, the United States is the first to approve its use among this age group, according to a press release from GSK. According to an FDA press announcement, the agency expedited the review and approval because belimumab could fulfill an unmet need.
The approval is based on a 1-year postapproval commitment study, which assessed efficacy, safety, and pharmacokinetics of 10 mg/kg belimumab plus standard therapy versus placebo plus standard therapy among children with SLE aged 5-11 years (n = 13) and those aged 12-17 years (n = 80). Although the study was not fully powered because of the rarity of the disease in this age group, it did find numerically higher SLE responder index response rates over 1 year among children treated with belimumab plus standard therapy (53%) than in those treated with placebo and standard therapy (44%).
Adverse reactions seen among this age group were consistent with those seen in adults, including nausea, diarrhea, pyrexia, nasopharyngitis, and bronchitis. The most common serious adverse reactions were serious infections. Belimumab has not been studied in combination with certain other drugs, such as other biologics or cyclophosphamide; therefore, combining it with such treatments is not recommended. Acute hypersensitivity reactions – including anaphylaxis and death – have been observed, even among patients who had previously tolerated belimumab.
Infusion reactions were common, so pretreat patients with an antihistamine. Also, do not administer the drug with live vaccines, the FDA noted.
More information can be found in the press announcement on the FDA website.
The B-lymphocyte stimulator–inhibitor called Benlysta already is approved for use in adults alongside standard therapy for SLE, and this approval marks the first such treatment available for children. Although there are regulatory submissions for use of this drug among children elsewhere, the United States is the first to approve its use among this age group, according to a press release from GSK. According to an FDA press announcement, the agency expedited the review and approval because belimumab could fulfill an unmet need.
The approval is based on a 1-year postapproval commitment study, which assessed efficacy, safety, and pharmacokinetics of 10 mg/kg belimumab plus standard therapy versus placebo plus standard therapy among children with SLE aged 5-11 years (n = 13) and those aged 12-17 years (n = 80). Although the study was not fully powered because of the rarity of the disease in this age group, it did find numerically higher SLE responder index response rates over 1 year among children treated with belimumab plus standard therapy (53%) than in those treated with placebo and standard therapy (44%).
Adverse reactions seen among this age group were consistent with those seen in adults, including nausea, diarrhea, pyrexia, nasopharyngitis, and bronchitis. The most common serious adverse reactions were serious infections. Belimumab has not been studied in combination with certain other drugs, such as other biologics or cyclophosphamide; therefore, combining it with such treatments is not recommended. Acute hypersensitivity reactions – including anaphylaxis and death – have been observed, even among patients who had previously tolerated belimumab.
Infusion reactions were common, so pretreat patients with an antihistamine. Also, do not administer the drug with live vaccines, the FDA noted.
More information can be found in the press announcement on the FDA website.