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Monday, 5th April 2004

The FDA issued a warning this month saying that patients on certain antidepressants should be monitored closely for warning signs of suicide.

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The FDA issued a warning this month saying that patients on certain antidepressants should be monitored closely for warning signs of suicide.

The FDA has sent a letter to drug manufacturers requesting labeling changes on these antidepressants -- warning of possible suicide, worsening depression, anxiety, and panic attacks in both adults and children. Most antidepressant labels already contain some fine-print statement about suicide, usually that the possibility is inherent with depression.

Although admittedly, it is not known for sure if these drugs do indeed increase suicidal behavior; the FDA decided that it was best to implement the labeling requirements immediately until it had a chance to examine the research available on the issue.

The 10 drugs of concern are newer generation antidepressants:

Most of these drugs belong to a class of antidepressants known as SSRIs or SSRI-like drugs which act through the brain chemical serotonin; while Remeron, Serzone and Wellbutrin, operate differently.

The issue started when dozens of anguished parents pleaded with FDA in a meeting last month to add such warnings, citing preteens and teenagers who hanged themselves or slashed their wrists shortly after starting the antidepressants. Parent after parent described children who had become extremely agitated or anxious shortly after starting the antidepressants, and seemingly sudden impulses that turned deadly. 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. 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.

In the UK because only one drug, Prozac, has been proven to alleviate pediatric depression, it is the only one allowed for use in children.

Available evidence

Initially research of suicidal behavior focused on children given these drugs. Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. But 109 patients experienced one or more possibly suicide-related behaviors or attempts, the FDA says.

The studies varied dramatically in what was considered suicidal behavior, making a clear link difficult, FDA scientists have contended. For example, among 19 patients classified as cutting themselves, almost all were superficial, with little bleeding. Worse, the youths most likely to commit suicide weren't allowed into those studies, so existing data likely won't settle the issue, the FDA's scientific advisers have warned. It?s 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.

The FDA had investigated reports of suicide among adult antidepressant users in the early 1990s and concluded there was no link ? but has now revealed that it is reanalyzing that question. Experts at Columbia University in New York are providing an independent review of the studies, looking carefully at descriptions of these events to determine whether those cases represent suicidal behavior. There is an ongoing awareness that children are particularly vulnerable.

What to look for

In addition to looking for signs of worsening depression, the following symptoms may also be a sign of a problem:

There also is concern for people who have bipolar disorder (manic depression) but don't know it. antidepressants have the potential for provoking a manic episode in these people, the FDA says. Doctors, patients, and family members should be on the lookout for any symptoms of mania, including feeling extremely happy or very irritable, inflated self-esteem, not needing as much sleep as usual, talking, or being more active than usual.

These changes should be monitored especially at the beginning of treatment or when the doses are increased or decreased.

Facts and numbers

Depression occurs in up to 10 percent of youth, and 1,883 10- to 19-year-olds killed themselves in 2001. Some 1.8 million teenagers attempted suicide that year, a quarter of them requiring medical attention, according to Columbia University scientists who are helping the FDA's probe. In 2002, almost 11 million prescriptions were dispensed to patients under 18 for SSRIs and other newer antidepressants, to treat depression and a host of other conditions, FDA said.

Article reviewed by:

Dr. Tamer Fouad, M.D.

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