Antidepressant Labels to Reflect Risk Data -- FDA
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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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Aug. 20 (Bloomberg) -- Antidepressant drugmakers such as Pfizer Inc., GlaxoSmithKline Plc and Wyeth will have to disclose trial results suggesting a higher risk of suicide among children and teenagers taking the pills, US regulators said.
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WASHINGTON - All antidepressants must carry a "black box" warning, the government's strongest safety alert, linking the drugs to increased suicidal thoughts and behavior among children and teens taking them, the Food and Drug Administration said Friday.    Because the warnings are primarily seen by doctors, the agency also is creating a medication guide for patients to advise them of the risk...
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The US Food and Drug Administration said on Thursday it &quot;generally supports&quot; an advisory panel&#39;s conclusion this week that antidepressants sometimes raise the risk of suicidal behavior in youth.
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The Food and Drug Administration is likely to require antidepressants to carry strong, "black box" warnings about links between increased suicidal behavior in children who take the drugs, an agency official said Thursday.
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Description: Scientific advisers to the Food and Drug Administration meeting in Washington, DC agree that there is a link between antidepressants and an increased risk of suicidal behavior among some children.
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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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MONDAY, Aug. 23 (HealthDayNews) -- While U.S. health officials consider imposing more warning labels on antidepressants used by children, experts recommend that parents make no treatment changes without consulting their child's doctor first.
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A federal advisory board is recommending that the Food and Drug Administration require all drugs used to treat depressed children come with a âblack boxâ warning of a link between the use of the antidepressants and suicidal leanings.
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A new study investigated the effects of changes to labels on antidepressant use nationwide.
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New guidelines are issued to doctors on the use of some anti-depressants, amid growing concern about their safety.
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WASHINGTON - The Food and Drug Administration "within a few days" will decide on a stronger warning for antidepressants, a top official told Congress.    The agency is likely to follow recommendations of federal advisers who want black boxes, the most strident warnings, to highlight links between the drugs and increased suicidal thoughts and actions of children...
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The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children
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Children taking antidepressant drugs may be at increased risk for suicidal behavior and thinking, and the government should require a "black box" warning label on the medications, an expert panel concluded Tuesday.
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An expert panel advising the Food and Drug Administration recommended today that antidepressants carry a warning in a black box on the label saying that the medications
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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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The Food and Drug Administration on Friday ordered that all antidepressants carry "black box" warnings that they "increase the risk of suicidal thinking and behavior" in children who take them.    Patients and their parents will be given medication guides that include the warning with each new prescription or refill...