FDA Sees Changes to Antidepressant Labels
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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 youth, according to documents released on Friday.
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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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Tough warning labels for antidepressants ordered by the Food and Drug Administration on Friday could save children&#39;s lives, experts say, but others warn that the move could backfire
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On Tuesday, a Food and Drug Administration advisory panel urged that antidepressants carry explicit warnings about an increased risk of suicidal behaviors in young people.
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WASHINGTON - All drugs used to treat depressed children should carry a "black box" warning of the antidepressants' link to increased suicidal thoughts and actions, says a panel of federal advisers.    The warning, among the strongest in the Food and Drug Administration's arsenal, should reach doctors no matter how they get drug information and would extend to drug advertising directed at patients...
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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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Following a two-day hearing on the safety and efficacy of antidepressants in children, an FDA advisory panel on Tuesday voted 15 to 8 to recommend that all antidepressants carry a black box warning -- the strongest warning issued by the government -- to
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Data on approximately 40,000 depressed adults in 234 clinical trials of antidepressants will be examined to see if the drugs increased suicidal thoughts or behaviors, said the US Food and Drug Administration.
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Federal drug regulators should warn physicians and patients in the strongest possible terms that antidepressants not only cause some children and teenagers to become suicidal
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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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Because some antidepressant drugs have been shown to lead to suicidal thoughts among children and teens, the FDA decrees that all manufacturers must carry a warning on their labels.
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WASHINGTON -- The Food and Drug Administration is ordering all drugmakers to add the government&#39;s strongest safety alert to all antidepressants.
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WASHINGTON - Federal health advisers considering more stringent warning labels for anti-depressants linked to suicidal thoughts among children were told on Tuesday that a new warning added in March appeared to have little impact on children's use of the drugs.    Children aged 1 to 17 still account for 7 percent of anti-depressants prescribed, said Michael Evans of the Food and Drug Administration's Office of Drug Safety...
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WASHINGTON -- Now that the Food and Drug Administration is considering suicide warnings on antidepressants for children, the agency is checking whether the same precaution might be needed for adults.
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U.S. health officials on Friday  ordered the makers of all antidepressants to include tough  warnings explaining that the drugs increase the chances of  suicidal behavior in some children and teens.
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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...
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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 an information guide for patients to advise them of the risk...