| Fda wants suicide warning on anti depressants { March 23 2004 } Original Source Link: (May no longer be active) http://www.suntimes.com/output/health/cst-nws-drug23.htmlhttp://www.suntimes.com/output/health/cst-nws-drug23.html
FDA wants suicide warning on anti-depressants' labels March 23, 2004 BY LAURAN NEERGAARD
WASHINGTON -- Doctors who prescribe some popular antidepressants should monitor their patients closely for warning signs of suicide, the government warned Monday.
The Food and Drug Administration asked makers of 10 drugs to add or strengthen suicide-related warnings on their labels.
The agency says it's not yet clear whether the drugs actually spur suicide on occasion -- or whether the underlying mental illness is to blame.
But 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's a difficult issue to sort out because depression itself can lead to suicide, and studies clearly show that anti-depressants have helped many people recover from depression.
Still, until the question is settled, FDA's own scientific advisers had urged stronger warnings that certain antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.
Monday, 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 FDA medical policy chief Dr. Robert Temple. ''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 FDA's investigation into the possible suicide link initially focused on children and teenagers, Monday's warning includes adults, too.
Manufacturers didn't immediately say if they'd comply with the FDA's request.
Drug critics said that they welcomed the FDA's decision, but added that suicide complaints first were raised many years ago.
''I'm just very sorry that it so long for them to act on this issue, because there's been so much tragedy that occurred,'' added Jennifer Tierney of Kernersville, N.C.
She described her daughter Jame as turning from a sweet, popular honor student into a raging loner after taking Effexor for migraines at age 14.
AP
ANTI-DEPRESSANTS NAMED IN FDA WARNING
The drugs covered by the government's warning: Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin.
AP
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