Healthy Skepticism Library item: 1462

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Publication type: news

Harris G.
F.D.A. Intensely Reviews Depression Drugs
The New York Times 2003 Oct 28

Full text:

The Food and Drug Administration issued a public health advisory yesterday that makes clear that the agency has grown increasingly skeptical that there is any link between antidepressant use and the risk of suicide in teenagers and children.

“I think probably that we have backed off a little bit from the advisory issued in June, which recommended against using Paxil,” said Dr. Thomas Laughren, a psychiatrist and an F.D.A. official. “I believe our position now is that we just don’t know.”

The F.D.A. plans to convene a panel on Feb. 2 to examine the relationship between suicide and antidepressant drug therapy. The panel will be asked to decide if the drugs should be prescribed to teenagers and children, if the drugs’ warnings sections should be changed, and what studies should be done to determine if there is a link between antidepressant use and suicide in teenagers and children.

To prepare for the meeting, the agency is undertaking an intensive review of pediatric studies of the drugs. In clinical trials of Paxil, it was found that children given the drug were more likely than those given inert pills to attempt suicide. The studies also found that the drug did not improve depressive symptoms in the subjects.

As a result, the F.D.A. warned in June that physicians should avoid prescribing Paxil to children and teenagers. Paxil, manufactured by GlaxoSmithKline, is among a class of drugs called selective serotonin reuptake inhibitors that also includes Prozac and Zoloft.

The advisory committee meeting in February will probably be controversial.

The F.D.A. convened a similar panel in 1991 to discuss claims that Prozac and similar pills might lead adults to become suicidal. The panel was mobbed by spectators and heard hours of testimony from people who thought they or their loved ones had become violent or suicidal after taking Prozac.

The 1991 panel ultimately voted that there was no compelling evidence linking the drugs with an increased risk of suicide. In recent interviews, 7 of the 10 panel members said that since disclosure of the Paxil studies, they would consider changing their votes.

The F.D.A. plans to re-examine many of the clinical conclusions made during studies of the drugs. For instance, some teenagers and children may have been incorrectly labeled as attempting suicide. “A number of the cases seem doubtful,” Dr. Laughren said. One girl was labeled as being suicidal after repeatedly slapping herself, Dr. Laughren said. Others were labeled suicidal after cutting themselves, he said.

The agency has also asked the drug companies to provide complete clinical histories on its trial participants to determine whether those given antidepressants may have been, in aggregate, at greater risk of committing suicide than those given inert pills. If so, the larger number of suicidal events among those given antidepressants could be explained by their increased suicidal tendencies and not to the drugs.

The agency also released a health advisory yesterday reminding doctors that among antidepressants, only Prozac had proved effective in treating pediatric depression. The agency also noted that the drugs should be used with caution and that patients should be closely monitored during initial drug therapy.