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US Lawmaker Blasts FDA Over Antidepressants Risk
Thu Sep 23, 2004 12:52 PM ET
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By Lisa Richwine

WASHINGTON (Reuters) - U.S. Food and Drug Administration staff first questioned the possibility of a link between antidepressant use and suicidal behavior in youth as far back as eight years ago, a senior U.S. lawmaker charged on Thursday.

Rep. Joe Barton, chairman of the House Energy and Commerce Committee, said one FDA medical reviewer raised the question of whether Pfizer Inc.'s Zoloft had increased the risk of suicidal behavior in pediatric clinical trials in a 1996 review.

Barton and other lawmakers criticized the agency's handling of an investigation of the connection between widely prescribed antidepressants and suicidal behavior in children and teens.

"The fact that children taking antidepressants were experiencing psychiatric adverse events at greater rates than adults was known at the agency as far back as 1996 and 1997," Barton, a Texas Republican, said at a hearing of the oversight and investigations subcommittee.

"I want to know: what did the agency do to respond to these concerns?" Barton said.

Recent questions about youth antidepressant use began in May 2003 when another FDA reviewer raised concerns that the drugs might increase the chances of suicidal acts. But top agency officials did not publicly confirm a link until last week.

Dr. Robert Temple, director of the FDA's Office of Medical Policy, defended the agency's handling of the controversy. He said data were unclear and officials wanted to be certain of the risks before warning doctors and the public.

"The agency realizes its responsibility to the public to find the right answer to this question," Temple said in remarks prepared for delivery at the hearing.

For some patients, the drugs can be life-saving by relieving depression, a serious mental illness that itself raises the risk of suicide. Many psychiatrists believe the drop in teen suicides in recent years is linked to the widespread use of antidepressants such as Prozac, Zoloft and Paxil.

The committee was scheduled to hear from Dr. Andrew Mosholder, the FDA reviewer who told officials months ago he felt the drugs could make youth suicide-prone. His supervisors disagreed and kept him from presenting his analysis at a public advisory committee meeting in February.

The FDA now is drafting new warnings for all antidepressants about the possibility of suicidal thoughts and actions among youth who take the drugs. A panel of outside experts has recommended the drug labels highlight the risk in a "black box," the strongest type of warning for prescription drugs.

An FDA analysis estimated 2 percent to 3 percent of children and teens who take antidepressants might have an elevated risk for suicidal behavior. But no suicides occurred in studies of more than 4,000 children as young as six.

Antidepressants include Eli Lilly and Co.'s Prozac, Pfizer's Zoloft, GlaxoSmithKline Plc's Paxil, Forest Laboratories Inc.'s Celexa and Wyeth's Effexor. Prozac also is sold under the generic name fluoxetine.

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