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Draft Guidance Given on Disclosures
The Food and Drug Administration has released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.
The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, the FDA said in a press briefing.
The FDA has 49 advisory committees with a total of more than 600 positions. Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings.
When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. The law limits the number of waivers to about 13% of all meeting participants, and in practice the agency grants waivers to fewer than 5%.
Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.
Public comment will be accepted through June 20.
Infusion Pumps to Be Regulated
The FDA will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse event reports, the agency announced.
Over the past 5 years the FDA has received more than 56,000 reports of adverse events, including more than 500 deaths, related to the pumps.
During that period there have been 87 recalls of infusion pumps undertaken to address identified safety concerns. The problems have ranged from manufacturing defects to software bugs to user error.
The FDA is taking several steps to address the devices' problems at the level of manufacture.
In the interim, the agency is advising clinicians to use several strategies to reduce risk when using infusion pumps: Have a plan in place to respond to pump failures; prevent errors by labeling infusion pump channels and tubing; check settings of infusion pumps; check patients for signs of under- or overinfusion; and promptly report adverse events to the FDA.
The FDA has also ordered Baxter, the manufacturer of Colleague Volumetric Infusion pumps, to recall and destroy all of these pumps currently in use in the United States, because of a “longstanding failure to correct many serious problems” with the pumps.
The FDA said that hospitals and other users of these Colleague pumps will be receiving more information from Baxter and the FDA about making the transition to other infusion devices.
GnRH Agonists Get Safety Study
The FDA is investigating whether treatment with a gonadotropin-releasing hormone agonist increases the risk of diabetes and cardiovascular events in men with prostate cancer.
In a statement issued May 3, the agency said that a preliminary analysis of several studies has identified an association between the use of gonadotropin-releasing hormone (GnRH) agonists and a “small increased risk” for diabetes, MI, stroke, and sudden death. The FDA has not made any conclusions about whether diabetes or these cardiovascular diseases are caused by treatment with these drugs, which are available in generic formulations and as brand-name products (Lupron, Eligard, Synarel, Trelstar, Vantas, Viadur, and Zoladex).
The studies under review are published observational studies and one randomized controlled clinical trial that compared androgen deprivation therapy using a GnRH agonist with other treatments in men with prostate cancer.
At this time, the FDA is advising that health care professionals should be aware of these potential risks “and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer,” and that they should monitor patients for diabetes and cardiovascular disease when treated with one of these drugs.
These drugs are also used in women (for endometriosis-related pain, anemia associated with uterine fibroids before a hysterectomy, and palliative treatment for advanced breast cancer), but “there are no known studies that have evaluated the risk of diabetes and heart disease” in women taking these drugs, according to the FDA.
Cancer Linked With Parkinson's Rx
An excess number of prostate cancer cases among men treated with the Parkinson's disease product that contains entacapone, carbidopa, and levodopa in a controlled clinical trial has prompted an FDA review of the combination drug's safety.
The agency is evaluating data from the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's Disease (STRIDE-PD) study, which found that over a mean of almost 3 years, the number of prostate cancers diagnosed among the men treated with entacapone, carbidopa, and levodopa (marketed as Stalevo) was about four times higher than the cases diagnosed among those treated with the carbidopa and levodopa combination product (marketed as Sinemet). The FDA has not concluded that Stalevo increases the risk of prostate cancer.
“Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening” in patients on this combination product, and patients should not stop taking their medication unless directed to do so, the statement added.
Warning Added to Thyroid Drug Label
Severe liver injuries have been associated with use of the antithyroid drug propylthiouracil, and the FDA has added a boxed warning to the product's label conveying this risk, the agency announced.
The warning for propylthiouracil (PTU) says that there have been reports of severe liver injury and acute liver failure, including fatalities, in those treated with the drug. Additionally, the agency said, for patients who are beginning treatment for hyperthyroidism, “it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery.”
PTU was approved in 1947 for the treatment of hyperthyroidism.
The warning also notes that because birth defects have been associated with use of the antithyroid drug methimazole during the first trimester, “propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.”
The FDA issued a warning to health care professionals about PTU's hepatoxicity in June 2009 and has added the boxed warning as part of the Risk Evaluation and Mitigation Strategy (REMS) for the drug.
There were 34 cases of severe liver injury associated with PTU reported between 1969 and 2009. The FDA is requiring a boxed warning because of the severity of these cases “and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity,” the statement added.
Rules for Home Use Strengthened
Citing reports of injuries and deaths associated with home use of medical devices that may not have been intended for use in that environment, the FDA announced that it will enhance its regulation of such products.
The agency aims to have a final policy in place within a year. Devices targeted by this initiative include cardiac monitors, ventilators, infusion pumps, dialysis machines, and wound-care products.
The FDA receives about 1,500 reports of adverse events occurring in homes each year. It is not clear how many of those are related to home use of medical devices; however, the agency has become increasingly concerned based on the trend toward early hospital discharge as well as aging of the population.
Among the types of events reported were ventilator failure because a caregiver did not hear an alarm; cat dander clogging a dialysis machine; and video-game interference causing the malfunction of implantable cardioverter defibrillators.
About 8 million people receive home care each year from 17,000 paid providers, at a cost of about $57 billion. Those figures don't account for people who receive care from family members.
The FDA will establish a multipronged approach to ensuring that manufacturers, home health agencies, patients, and caregivers have the information needed to reduce the risk of malfunctions, injuries, and deaths.
Draft Guidance Given on Disclosures
The Food and Drug Administration has released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.
The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, the FDA said in a press briefing.
The FDA has 49 advisory committees with a total of more than 600 positions. Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings.
When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. The law limits the number of waivers to about 13% of all meeting participants, and in practice the agency grants waivers to fewer than 5%.
Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.
Public comment will be accepted through June 20.
Infusion Pumps to Be Regulated
The FDA will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse event reports, the agency announced.
Over the past 5 years the FDA has received more than 56,000 reports of adverse events, including more than 500 deaths, related to the pumps.
During that period there have been 87 recalls of infusion pumps undertaken to address identified safety concerns. The problems have ranged from manufacturing defects to software bugs to user error.
The FDA is taking several steps to address the devices' problems at the level of manufacture.
In the interim, the agency is advising clinicians to use several strategies to reduce risk when using infusion pumps: Have a plan in place to respond to pump failures; prevent errors by labeling infusion pump channels and tubing; check settings of infusion pumps; check patients for signs of under- or overinfusion; and promptly report adverse events to the FDA.
The FDA has also ordered Baxter, the manufacturer of Colleague Volumetric Infusion pumps, to recall and destroy all of these pumps currently in use in the United States, because of a “longstanding failure to correct many serious problems” with the pumps.
The FDA said that hospitals and other users of these Colleague pumps will be receiving more information from Baxter and the FDA about making the transition to other infusion devices.
GnRH Agonists Get Safety Study
The FDA is investigating whether treatment with a gonadotropin-releasing hormone agonist increases the risk of diabetes and cardiovascular events in men with prostate cancer.
In a statement issued May 3, the agency said that a preliminary analysis of several studies has identified an association between the use of gonadotropin-releasing hormone (GnRH) agonists and a “small increased risk” for diabetes, MI, stroke, and sudden death. The FDA has not made any conclusions about whether diabetes or these cardiovascular diseases are caused by treatment with these drugs, which are available in generic formulations and as brand-name products (Lupron, Eligard, Synarel, Trelstar, Vantas, Viadur, and Zoladex).
The studies under review are published observational studies and one randomized controlled clinical trial that compared androgen deprivation therapy using a GnRH agonist with other treatments in men with prostate cancer.
At this time, the FDA is advising that health care professionals should be aware of these potential risks “and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer,” and that they should monitor patients for diabetes and cardiovascular disease when treated with one of these drugs.
These drugs are also used in women (for endometriosis-related pain, anemia associated with uterine fibroids before a hysterectomy, and palliative treatment for advanced breast cancer), but “there are no known studies that have evaluated the risk of diabetes and heart disease” in women taking these drugs, according to the FDA.
Cancer Linked With Parkinson's Rx
An excess number of prostate cancer cases among men treated with the Parkinson's disease product that contains entacapone, carbidopa, and levodopa in a controlled clinical trial has prompted an FDA review of the combination drug's safety.
The agency is evaluating data from the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's Disease (STRIDE-PD) study, which found that over a mean of almost 3 years, the number of prostate cancers diagnosed among the men treated with entacapone, carbidopa, and levodopa (marketed as Stalevo) was about four times higher than the cases diagnosed among those treated with the carbidopa and levodopa combination product (marketed as Sinemet). The FDA has not concluded that Stalevo increases the risk of prostate cancer.
“Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening” in patients on this combination product, and patients should not stop taking their medication unless directed to do so, the statement added.
Warning Added to Thyroid Drug Label
Severe liver injuries have been associated with use of the antithyroid drug propylthiouracil, and the FDA has added a boxed warning to the product's label conveying this risk, the agency announced.
The warning for propylthiouracil (PTU) says that there have been reports of severe liver injury and acute liver failure, including fatalities, in those treated with the drug. Additionally, the agency said, for patients who are beginning treatment for hyperthyroidism, “it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery.”
PTU was approved in 1947 for the treatment of hyperthyroidism.
The warning also notes that because birth defects have been associated with use of the antithyroid drug methimazole during the first trimester, “propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.”
The FDA issued a warning to health care professionals about PTU's hepatoxicity in June 2009 and has added the boxed warning as part of the Risk Evaluation and Mitigation Strategy (REMS) for the drug.
There were 34 cases of severe liver injury associated with PTU reported between 1969 and 2009. The FDA is requiring a boxed warning because of the severity of these cases “and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity,” the statement added.
Rules for Home Use Strengthened
Citing reports of injuries and deaths associated with home use of medical devices that may not have been intended for use in that environment, the FDA announced that it will enhance its regulation of such products.
The agency aims to have a final policy in place within a year. Devices targeted by this initiative include cardiac monitors, ventilators, infusion pumps, dialysis machines, and wound-care products.
The FDA receives about 1,500 reports of adverse events occurring in homes each year. It is not clear how many of those are related to home use of medical devices; however, the agency has become increasingly concerned based on the trend toward early hospital discharge as well as aging of the population.
Among the types of events reported were ventilator failure because a caregiver did not hear an alarm; cat dander clogging a dialysis machine; and video-game interference causing the malfunction of implantable cardioverter defibrillators.
About 8 million people receive home care each year from 17,000 paid providers, at a cost of about $57 billion. Those figures don't account for people who receive care from family members.
The FDA will establish a multipronged approach to ensuring that manufacturers, home health agencies, patients, and caregivers have the information needed to reduce the risk of malfunctions, injuries, and deaths.
Draft Guidance Given on Disclosures
The Food and Drug Administration has released draft guidance designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.
The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, the FDA said in a press briefing.
The FDA has 49 advisory committees with a total of more than 600 positions. Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings.
When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. The law limits the number of waivers to about 13% of all meeting participants, and in practice the agency grants waivers to fewer than 5%.
Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.
Public comment will be accepted through June 20.
Infusion Pumps to Be Regulated
The FDA will regulate the design and manufacture of infusion pumps in the wake of thousands of adverse event reports, the agency announced.
Over the past 5 years the FDA has received more than 56,000 reports of adverse events, including more than 500 deaths, related to the pumps.
During that period there have been 87 recalls of infusion pumps undertaken to address identified safety concerns. The problems have ranged from manufacturing defects to software bugs to user error.
The FDA is taking several steps to address the devices' problems at the level of manufacture.
In the interim, the agency is advising clinicians to use several strategies to reduce risk when using infusion pumps: Have a plan in place to respond to pump failures; prevent errors by labeling infusion pump channels and tubing; check settings of infusion pumps; check patients for signs of under- or overinfusion; and promptly report adverse events to the FDA.
The FDA has also ordered Baxter, the manufacturer of Colleague Volumetric Infusion pumps, to recall and destroy all of these pumps currently in use in the United States, because of a “longstanding failure to correct many serious problems” with the pumps.
The FDA said that hospitals and other users of these Colleague pumps will be receiving more information from Baxter and the FDA about making the transition to other infusion devices.
GnRH Agonists Get Safety Study
The FDA is investigating whether treatment with a gonadotropin-releasing hormone agonist increases the risk of diabetes and cardiovascular events in men with prostate cancer.
In a statement issued May 3, the agency said that a preliminary analysis of several studies has identified an association between the use of gonadotropin-releasing hormone (GnRH) agonists and a “small increased risk” for diabetes, MI, stroke, and sudden death. The FDA has not made any conclusions about whether diabetes or these cardiovascular diseases are caused by treatment with these drugs, which are available in generic formulations and as brand-name products (Lupron, Eligard, Synarel, Trelstar, Vantas, Viadur, and Zoladex).
The studies under review are published observational studies and one randomized controlled clinical trial that compared androgen deprivation therapy using a GnRH agonist with other treatments in men with prostate cancer.
At this time, the FDA is advising that health care professionals should be aware of these potential risks “and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer,” and that they should monitor patients for diabetes and cardiovascular disease when treated with one of these drugs.
These drugs are also used in women (for endometriosis-related pain, anemia associated with uterine fibroids before a hysterectomy, and palliative treatment for advanced breast cancer), but “there are no known studies that have evaluated the risk of diabetes and heart disease” in women taking these drugs, according to the FDA.
Cancer Linked With Parkinson's Rx
An excess number of prostate cancer cases among men treated with the Parkinson's disease product that contains entacapone, carbidopa, and levodopa in a controlled clinical trial has prompted an FDA review of the combination drug's safety.
The agency is evaluating data from the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's Disease (STRIDE-PD) study, which found that over a mean of almost 3 years, the number of prostate cancers diagnosed among the men treated with entacapone, carbidopa, and levodopa (marketed as Stalevo) was about four times higher than the cases diagnosed among those treated with the carbidopa and levodopa combination product (marketed as Sinemet). The FDA has not concluded that Stalevo increases the risk of prostate cancer.
“Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening” in patients on this combination product, and patients should not stop taking their medication unless directed to do so, the statement added.
Warning Added to Thyroid Drug Label
Severe liver injuries have been associated with use of the antithyroid drug propylthiouracil, and the FDA has added a boxed warning to the product's label conveying this risk, the agency announced.
The warning for propylthiouracil (PTU) says that there have been reports of severe liver injury and acute liver failure, including fatalities, in those treated with the drug. Additionally, the agency said, for patients who are beginning treatment for hyperthyroidism, “it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery.”
PTU was approved in 1947 for the treatment of hyperthyroidism.
The warning also notes that because birth defects have been associated with use of the antithyroid drug methimazole during the first trimester, “propylthiouracil may be the treatment of choice during and just before the first trimester of pregnancy.”
The FDA issued a warning to health care professionals about PTU's hepatoxicity in June 2009 and has added the boxed warning as part of the Risk Evaluation and Mitigation Strategy (REMS) for the drug.
There were 34 cases of severe liver injury associated with PTU reported between 1969 and 2009. The FDA is requiring a boxed warning because of the severity of these cases “and to ensure that healthcare professionals are aware of this risk and are vigilant for the signs and symptoms of hepatic toxicity,” the statement added.
Rules for Home Use Strengthened
Citing reports of injuries and deaths associated with home use of medical devices that may not have been intended for use in that environment, the FDA announced that it will enhance its regulation of such products.
The agency aims to have a final policy in place within a year. Devices targeted by this initiative include cardiac monitors, ventilators, infusion pumps, dialysis machines, and wound-care products.
The FDA receives about 1,500 reports of adverse events occurring in homes each year. It is not clear how many of those are related to home use of medical devices; however, the agency has become increasingly concerned based on the trend toward early hospital discharge as well as aging of the population.
Among the types of events reported were ventilator failure because a caregiver did not hear an alarm; cat dander clogging a dialysis machine; and video-game interference causing the malfunction of implantable cardioverter defibrillators.
About 8 million people receive home care each year from 17,000 paid providers, at a cost of about $57 billion. Those figures don't account for people who receive care from family members.
The FDA will establish a multipronged approach to ensuring that manufacturers, home health agencies, patients, and caregivers have the information needed to reduce the risk of malfunctions, injuries, and deaths.