Sept. 13, 2004 — Children and adolescents taking a range of popular prescription medications for depression appear to be at higher risk for suicide attempts than patients who don’t take the drugs, a pair of FDA analyses have concluded.
The drugs of concern are all newer-generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone, and Wellbutrin. Most are known to affect the brain chemical serotonin. Only Prozac is FDA-approved to treat depression in children.
Overall, these medications may increase the risk of suicidal thoughts or attempts by 2% to 3%, the reviews show.
Officials stress that no completed suicides were recorded in the 23 drug company studies making up the reviews. But they also say that a potentially dangerous elevated risk of childhood suicidal behavior is consistent in seven drugs in the group.
“That’s beyond the risk that occurs with the disease” alone, says Tarek A. Hammad, MD, an FDA senior medical officer who conducted one of the reviews, tells a panel of outside experts advising the agency.
Hammad’s analysis showed children with a variety of disorders who used some of these drugs, including Zoloft, Remeron, Luvox, and Wellbutrin, were 1.4 to 5.5 more likely to have suicidal thoughts or behaviors than similarly ill children taking a placebo.
Despite the elevated risk, suicidal behavior was rare in the studies. Potentially suicidal events were reported in 109 out of nearly 2,500 patients.
But the effect persisted when analysts limited their review to children taking the drugs only for depression. wellbutrin. Children with depression taking one popular drug, Effexor XR, showed self-harming behavior or considered suicide nearly nine times as often as children not taking medication.
“It is important to put in mind that these are just estimates,” says Hammad, stressing that his audit was retrospective in nature and looked at studies not specifically designed to pick up on a heightened risk of suicide.
Consistent Findings
The study confirms similar findings in another FDA review conducted last year by Andrew D. Mosholder, MD. That review became a subject of heated controversy when Mosholder’s FDA superiors barred him from presenting his conclusions at an agency hearing in February of this year.
As late as last week, lawmakers accused FDA officials of working to suppress key data on the efficacy and safety of antidepressant drugs. Several drug company executives told a House committee on Thursday that the FDA encouraged them to withhold data undermining the drugs’ effectiveness for fear of scaring doctors and the public.
Robert Temple, MD, head of the FDA’s scientific investigations division, tells reporters that he does not regret withholding Mosholder’s determination last winter even in light of Monday’s confirmatory review. His conclusions were premature given what was known at the time about performance of antidepressant medications, he says.

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