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FDA links antidepressants with risk to youths -WSJ
Thursday August 5, 5:04 am ET

NEW YORK, Aug 5 (Reuters) - A new U.S. Food and Drug Administration analysis of clinical trial data suggests a link between antidepressant drugs and suicidal tendencies among young people, the Wall Street Journal said on Thursday, citing a draft document containing the analysis.

The analysis, which focused on 25 studies of nine drugs, found that children and teenagers who took the drugs were twice as likely to exhibit behavior or thoughts that appeared suicidal, compared with those who took placebos, the newspaper said.

FDA 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 issue is controversial because Congress is examining the FDA decision this year to block a staffer from revealing a similar finding, based on many of the same trials. The FDA may face pressure to limit young people's use of the drugs, the newspaper said.

An FDA spokeswoman told the newspaper the agency is still reviewing the data, and could not comment before an advisory committee meets to review a final version of the analysis, expected on September 13 and 14.

Among the drugs included in the analysis are Forest Laboratories Inc.'s (NYSE:FRX - News) Celexa, GlaxoSmith Kline Plc's (London:GSK.L - News) Paxil and Wellbutrin, Pfizer Inc.'s (NYSE:PFE - News) Zoloft, Wyeth's (NYSE:WYE - News) Effexor and Eli Lilly & Co.'s (NYSE:LLY - News) Prozac, which is also available generically, the newspaper said.

Earlier this year, Rep. Joe Barton, a Texas Republican who chairs the House Energy and Commerce Committee, said there were "troubling questions of whether FDA supervisors inappropriately suppressed significant information that would have been of consequence to their own advisory committee, not to mention the public".

The primary medical reviewer on the issue, Andy Mosholder, found a connection between antidepressants and increased suicidal tendencies, but other reviewers disagreed, saying more analysis was needed. Agency officials asked Columbia University experts to look at various data.

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

In April, Express Scripts Inc. (NasdaqNM:ESRX - News), which keeps statistics on drug use, said pre-school children's use of antidepressants nearly doubled between 1998 and 2002, the fastest growth among any age group.



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