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FDA TO DRUGMAKERS: Suicide Warning Urged

Amid reports raising worries about teens on antidepressants, agency seeks tougher wording on the labels

Mar 23, 2004 | NEWSDAY a href="">More information on Serzone side effects

Federal regulators yesterday asked pharmaceutical companies to strengthen the wording on labels on 10 antidepressants to warn the drugs may heighten risk of suicide.

"We don't know yet if there is a link between antidepressant use and suicide," said Dr. Thomas Laughren, team leader of the Food and Drug Administration's psychopharmacology group. But yesterday's recommendation comes on the heels of an FDA advisory committee's recommendation last month to add the warning while the committee continues to investigate. Laughren said the warning is intended for all ages, not just children and teenagers.

"This is a good warning," said Dr. Harold Koplewicz, director of New York University's Child Study Center in Manhattan, and an expert on childhood depression. Koplewicz said 11 million prescriptions for antidepressants were written last year, most probably issued by primary care doctors.

"We have very effective medicines, but doctors need to know how to use them," Koplewicz said. Side effects, such as anxiety, generally occur in the first few months on the drugs. This period is a critical window for observing whether patients are improving on the prescribed drug and dosage.

Medicines for which the new warning is recommended are Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

The only medicine tested and FDA- approved for teenage depression is Prozac. It and two other selective serotonin reuptake inhibitors, or SSRIs, Zoloft and Luvox, are approved for obsessive-compulsive disorder in young people.

But anecdotal reports of suicides among young people taking SSRIs have appeared in recent years, sparking a debate on the safety of these medicines. Last year, the drug regulatory agency in the United Kingdom banned Paxil for use in children. The FDA quickly put together an advisory committee to review the science.

Now, the FDA has asked psychiatrists specializing in teenage suicide to go case by case through 25 papers, clinical trials that represent more than 4,000 young people, some of whom were reported to have made some suicidal gesture during the studies.

Psychiatrists at Columbia University College of Physicians and Surgeons, as well as others nationwide, will re-evaluate each case. "While we are trying to figure this out, we are urging doctors to be more cautious," Laughren said.

Dr. David Fassler, a child psychiatrist at the University of Vermont, appreciates the new warning, but worries that the attention may frighten some parents and reduce the likelihood that they seek help for their children. "That would be a tragedy," said Fassler, who thinks medicine, in conjunction with some form of talk therapy, can be extremely helpful. "One of the biggest risks is not treating at all," he said.

The 10 Drugs

The Food and Drug Administration yestefday asked makers of these antidepressants to add labels urging that patients on the drugs be monitored for signs they are at risk of suicide.

Prozac (fluoxetine)

Zoloft (sertraline)

Paxil (paroxetine)

Luvox (fluvoxamine)

Celxa (citalopram)

Lexapro (escitalopram)

Wellbutrin (bupropion)

Effexor (venlafaxine)

Serzone (nefazodone)

Remeron (mirtazapine)

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