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FDA Warns Of Link Between Antidepressants, Suicide

Patients Should Be Closely Monitored, Officials Say

POSTED: 1:20 pm EST March 22, 2004
UPDATED: 6:04 pm EST March 22, 2004

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The Food and Drug Administration is urging doctors to monitor patients prescribed antidepressants for suicidal behavior.

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NewsCenter 5's Jim Boyd reported that the agency has also asked the makers of 10 of the drugs to strengthen their warning labels.

Each year, doctors and psychiatrists write millions of prescriptions for anti-depressants.

On Monday, the FDA flagged 10 popularly prescribed medications and issued a public advisory calling for a more careful monitoring of patients who are taking them.

"They're saying be careful of emerging possible side effects, and all of the anti-depressants have side effects, and also be careful of depression getting worse and watch for patients who struggle with suicidal thoughts and suicidal actions," said Andrew Nierenberg of Massachusetts General Hospital.

Nierenberg, the associate director of the depression program at Massachusetts General Hospital, said such monitoring is especially critical for new patients.

"We know from having treated many depressed patients, that first people get side effects before they get benefit. And that it takes several weeks for them to feel better," said Nierenberg.

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.

The FDA advisory also asked makers of the anti-depressants to include stronger cautions and warnings in their packaging putting patients, doctors and caregivers on alert.

But Nierenberg said he hopes the FDA announcement is not misinterpreted.

"This is not something to be frightened about. And it is certainly not a reason for anyone to stop taking the anti-depressants that may have helped," he said. "To stop it prematurely, because of an announcement like this, really would be a big mistake."

The FDA stressed that nowhere does its research indicate that anti-depressants trigger suicide. In fact, the agency said, depression itself can cause suicide.

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