F.D.A. Requiring Suicide Studies in Drug Trials
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Drug makers are being asked for the first time to put a comprehensive suicide assessment into clinical trials.
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The US Food and Drug Administration (news - web sites) plans to update antidepressant labels to reflect studies that suggest a link between the drugs and suicide in youth, according to documents released on Friday.
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A report to be released on Friday finds the U.S. Food and Drug Administration does very little to ensure the safety of patients who help test drugs in clinical trials, The New York Times reports.
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The discovery that antidepressants  may increase suicidal tendencies in children has prompted some  lawmakers and physicians to ask if changes are needed to  financial incentives given to drug makers for pediatric  research.
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Waiting for subjects to die is a somber part of the oncology clinical trial process.
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Democratic lawmakers in Congress introduced legislation yesterday that would require makers of drugs and medical devices to register clinical trials of their products in a public database when they start and report the test results on it.
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Medical researchers said the U.S. needs a system independent of the F.D.A. to detect harmful effects of drugs already on the market.
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Families and doctors should be cautioned that children taking antidepressant drugs may be at an increased risk for suicidal behavior and thinking, and the government should require a prominent
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Congress has been investigating the FDA&#39;s decisions in both the Vioxx and antidepressant cases. The probes have focused on agency reviewers who warned about potential problems but claimed their research was ignored or suppressed by other officials.
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WASHINGTON The Food and Drug Administration has ordered a sweeping review of studies involving prescription painkillers like Celebrex and Bextra.
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The British Medical Journal (BMJ) said  on Friday it has sent documents to U.S. health regulators that  it said appear to suggest a link between the antidepressant  drug Prozac and suicidal behavior.
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Academic institutions and researchers are widely viewed as impartial actors in drug trials. But that independence often comes with strings attached.
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Agency wants to learn if drugs can lead to suicide in young people; most major drugmakers impacted. NEW YORK  - The Food and Drug Administration is expected to call for changes to labels for antidepressants to reflect a new agency analysis ...
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The Food and Drug Administration yesterday ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.
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BETHESDA, Md.  - A U.S. advisory panel urged  regulators on Tuesday to require a "black box" warning on  antidepressant labels about the increased risk of suicidal  behavior in youth who take the drugs.
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The British Medical Journal (BMJ) said on Friday it has sent documents to U.S. health regulators that it said appear to suggest a link between the antidepressant drug Prozac and suicidal behavior.
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WASHINGTON - A new Food and Drug Administration analysis backs earlier suggestions of a link between at least some antidepressants used by children and suicidal tendencies, prompting the agency to prepare new warnings.    Exactly what those warnings will say, and which drugs will be affected, hasn't been settled, according to FDA documents released Friday...