F.D.A. Requiring Suicide Studies in Drug Trials
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Makers of drugs to treat obesity, depression and many other conditions are being asked for the first time to include suicide assessments in their clinical trials.
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Concern over antidepressants is becoming the catalyst for reform of clinical trial reporting.
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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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The Food and Drug Administrationâs proposed rules would allow drug and device makers to provide doctors with medical journal articles about product uses that have not been approved by the F.D.A.
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WASHINGTON -- The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
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The initiative is part of an effort to ferret out unpublished research consucted by pharmaceutical companies that finds medications to be ineffective or dangerous.
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Description: A Food and Drug Administration study seems to confirm suspicions that antidepressant drugs may increase the risk of suicidal behavior in children and teens.
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The U.S. Food and Drug  Administration plans to update antidepressant labels to reflect  studies that suggest a link between the drugs and suicide in  youths, despite remaining cautious about the strength of such  ties, the agency said on Friday.
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The Food and Drug Administration yesterday called for an evaluation of all prevention studies involving two controversial painkillers - Celebrex and Bextra - to ensure adequate protection for participants who use the pills.
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The F.D.A. ordered drug companies to add strong warnings to antidepressants, saying that they can cause suicidal thoughts and actions in children and teenagers.
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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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The U.S. Food and Drug  Administration plans to update antidepressant labels to reflect  studies that suggest a link between the drugs and suicide in  youths, but remains cautious about the strength of such ties,   according to documents released on Friday.
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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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Federal health advisers considered Monday whether strong warning labels were needed on antidepressants because they have been linked to suicidal tendencies among children who take them.
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A Food and Drug Administration advisory panel has recommended putting a &quot;black box&quot; warning on antidepressants to indicate they might raise the risk of suicidal behavior in children and teens.
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Since the F.D.A. has issued a strong warning about adolescent use of antidepressants, will the inevitable decrease in prescriptions ultimately lead to more teenage suicides?
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Waiting for subjects to die is a somber part of the oncology clinical trial process.