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FDA: Some antidepressants need stronger suicide warnings

  WASHINGTON — Doctors who prescribe some popular antidepressants should monitor their patients closely for warning signs of suicide, especially when they first start the pills or change a dose, the government warned yesterday. The Food and Drug Administration asked makers of 10 drugs to add or strengthen suicide-related warnings on their labels. The agency says it is not clear whether the drugs actually spur suicide on occasion, or whether the underlying mental illness is to blame. But the FDA bowed to pressure from anguished families who, at an emotional meeting last month, blamed the pills for their loved ones' suicides and pleaded for better warnings. It is a difficult issue to sort out because depression itself can lead to suicide, and studies clearly show that antidepressants have helped many people recover from depression.

Covered drugs Antidepressants covered by the Food and Drug Administration's warning: • Celexa • Effexor • Lexapro • Luvox • Paxil • Prozac • Remeron • Serzone • Wellbutrin • Zoloft

Yesterday, the FDA followed that recommendation, stressing that the most vulnerable time is when a patient starts therapy or changes the dose.

"We think this is good advice whether the drugs increase the risk or not," said Dr. Robert Temple, the FDA's medical-policy chief. "There's a reason people are put on therapy: Their depression is worse or somebody's worried about it. Maybe that's what drives it (reports of suicides), or maybe it's the drugs. In either case, you really need to pay attention in the early days." While the FDA's investigation into the possible suicide link initially focused on children and teenagers, yesterday's warning includes adults, too. The FDA had investigated reports of suicide among adult antidepressant users in the early 1990s and concluded there was no link. However, it said yesterday it was taking a new look at the issue.

The drugs of concern are newer-generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro and Luvox, which are called SSRIs or SSRI-like drugs; and Remeron, Serzone and Wellbutrin, which operate differently.

Manufacturers didn't immediately say if they would comply with the FDA's request.

British health authorities sounded the alarm last year, saying long-suppressed research suggests that serotonin-affecting antidepressants might sometimes increase the risk of suicidal behavior in children and teens. Excepting one drug, Prozac, that has been proved to alleviate pediatric depression, Britain declared the other six SSRIs or SSRI-like drugs unsuitable for depressed youth. Britain didn't mention the other three drugs listed in the U.S. notice.

The FDA issued a caution on pediatric use last year but says it doesn't have proof the drugs are to blame. Among 25 studies of the suspect medications, involving 4,000 children and teens, there were no suicides. Some 109 patients experienced one or more possibly suicide-related behaviors or attempts, but the studies varied dramatically in what was considered suicidal behavior.

But critics flooded an FDA meeting last month demanding stronger action. Days later, the issue again made headlines when a 19-year-old woman taking part in a study of Eli Lilly & Co.'s experimental new antidepressant duloxetine hanged herself in a company-run facility.

Most antidepressant labels already contain some fine-print statement about suicide, usually that the possibility is inherent with depression.

The FDA asked yesterday for explicit explanations of worrisome behavior changes to be placed in bold print under the prominent "warnings" section of those labels: agitation, anxiety, irritability and recklessness. Doctors spotting those traits should consider prescribing a lower dose or stopping the drug, the FDA said.

The drugs are used for many conditions other than depression; the warning applies regardless of the reason for use.