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Antidepressant Safety Review Set for September

Mon Aug 2, 6:44 PM ET

WASHINGTON (Reuters) - A U.S. advisory committee will meet in September to once again consider whether antidepressants raise the risk of suicide in children and teenagers, regulators announced on Monday.

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The Food and Drug Administration (news - web sites) will present a new analysis of antidepressant data and ask the panel if more research or regulatory action is needed, according to a notice to be published in the Federal Register.

FDA (news - web sites) officials are trying to determine if widely used antidepressants such as Prozac make children or teenagers suicide-prone, or whether the disease itself is responsible.

The advisory panel of outside experts considered preliminary data in February and urged stronger warnings to the public while the FDA probed further. In March, the agency urged close monitoring of antidepressant patients for signs of worsening depression or suicidal thoughts.

Agency officials, meanwhile, asked Columbia University experts to look at reports of suicidal behavior among children who took antidepressants during clinical trials. Many of the reports were vague and difficult to interpret, FDA officials have said.

The FDA's analysis of the Columbia team's assessment "is in the works," Dr. Robert Temple, FDA's associate director for medical policy, said in an interview.

He said he did not know whether the FDA would release its analysis ahead of the Sept. 13-14 advisory committee meeting.

"We'll try to let people see what we have as soon as we can," Temple said.

Some lawmakers and other critics have questioned whether the FDA tried to keep secret one agency reviewer's conclusion that the drugs were linked to a higher suicide risk. FDA officials have denied the charge.

Some also have asked why the FDA has taken longer to act than British authorities, who have advised doctors not to prescribe most of the drugs known as selective serotonin reuptake inhibitors to anyone under 18.


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