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FDA Issues Second Warning Re Antidepressants Causing Suicide

July 1, 2005

WASHINGTONFood 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.

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.

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.

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.

...[T]here are concerns that antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects....

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.

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