U.S. Issues Antidepressant Warning

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By Elizabeth Shogren, Times Staff Writer

WASHINGTON — The government today told the makers of 10 popular antidepressants to add to their labels the warning that people who take them should be monitored for suicidal behavior.

The Food and Drug Administration warned doctors, patients and their families to closely monitor adults and children taking the medications. And it told them to watch out for other negative behaviors associated with the drugs, including agitation, hostility, severe restlessness, insomnia and mania.

It directed the drug companies to include lengthy warnings on the drug labels of Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron — drugs taken by an estimated 20 million people each year.

The warnings came after an FDA advisory panel heard emotional testimony last month from dozens of patients and family members who blame the drugs for suicide attempts, suicides and violent acts. The FDA said it was not clear whether antidepressants contributed to the emergence of suicidal thoughts and behavior, but, at the urging of the advisory panel, the agency decided to issue the warnings before it completed a thorough review of the drugs.

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