FDA Warns About Antidepressants, Suicide

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FDA Warns About Antidepressants, Suicide

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The Food and Drug Administration issued a second public warning Friday

that adults who use antidepressants should be closely monitored for

warning signs of suicide, especially when they first start the pills or

change a dose.

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Much of the concern over suicide and antidepressants has centered on

children who use the drugs. The FDA last fall determined there is a

real, but small, increase in risk of suicidal behavior for children and

ordered the labels of all antidepressants to say so.

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A year ago, the FDA issued a warning that adults, too, may be at

increased risk. The agency began reanalyzing hundreds of studies of the

drugs to try to determine if that's the case, and told makers to add or

strengthen suicide-related warnings on their labels in the meantime.

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Since then, several new studies have been published in medical journals

about a possible connection. Citing them, FDA issued a new public health

advisory reminding doctors and patients to watch closely for suicidal

thinking or worsening depression and seek medical care if it happens.

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It's a difficult issue to sort out because depression itself can lead to

suicide and studies show that antidepressants have helped many people

recover.

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But there are concerns that antidepressants may cause agitation, anxiety

and hostility in a subset of patients who may be unusually prone to rare

side effects. Also, psychiatrists say there is a window period of risk

just after pill use begins, before depression is really alleviated but

when some patients experience more energy, perhaps enabling them to act

on suicidal tendencies.

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In addition to the advisory, the FDA also updated its Web site with a

notice about a higher-than-expected rate of suicide attempts in research

with the nation's newest antidepressant, Eli Lilly's Cymbalta. Those

studies were in women trying Cymbalta as an incontinence treatment; it

was never approved for that use. The FDA insisted when it approved

Cymbalta last year that studies of depressed patients showed no suicide

link.