US FDA agrees on antidepressant risks for youth

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The U.S. Food and Drug Administration said on Thursday it “generally supports” an advisory panel’s conclusion this week that antidepressants sometimes raise the risk of suicidal behavior in youth.

The agency said in a statement it was working on new warning labels for all antidepressants to explain the risk.

The FDA “generally supports the recommendations” of the panel, which included tough warnings for all antidepressants sold as well as a pamphlet in patient-friendly language to be handed out with every prescription, the statement said.

FDA officials first became aware of a possible link to suicidal behavior in May 2003. Critics charge the agency was slow to act and instead chose to discount the findings of one of its own researchers.

A recent FDA analysis concluded two or three out of every 100 young people treated with antidepressants might face an elevated risk of suicidal thoughts or actions. In two dozen pediatric clinical trials, no patient actually committed suicide.

Advisory panel members voted 15-8 on Tuesday to urge the FDA to require a “black box” warning, the strongest type used for prescription drugs, to get the message to doctors.

Some worried that highlighting the small increase in risk might frighten parents and doctors and discourage treatment of depressed children and teens who could benefit. Depression itself can provoke suicide.

The American Psychiatric Association said those concerns were valid and urged the FDA to consider that argument as it crafts the new warnings. “We believe the biggest threat to a depressed child’s well-being is to receive no care at all,” the group said in a statement.

Other panelists said they felt the drugs were over-prescribed and they hoped use would decline. Studies have failed to show most of the drugs work for children, something the panel said also should be highlighted on the drug labels.

The panel said safety concerns applied to all nine drugs studied, including Prozac, GlaxoSmithKline Plc’s Paxil and Wellbutrin, Pfizer Inc.’s Zoloft, Forest Laboratories Inc.’s Celexa, Wyeth’s Effexor, Solvay SA’s Luvox and Akzo Nobel NV’s Remeron were also reviewed.

Bristol-Myers Squibb’s Serzone was also included, but the company discontinued the drug earlier this year.

The black box warnings should also appear on older antidepressants such as tricyclics, the panel said.

Data on suicidal behavior varied among drugs, but “we are unable to conclude any single agent is free from risk at this time,” the panel ruled.

Only Prozac, which also is sold generically under the name fluoxetine, has been shown to work in children and is FDA-approved for pediatric use.

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