FDA Warns About Antidepressants, Suicide

The new warning was prompted by recent scientific publications that suggested a connection, the Food and Drug Administration said. The agency said it was in the process of reviewing data from drug manufacturers to determine the extent and seriousness of the risk, a review it said could take more than a year. The new advisory follows action taken in March 2004, when the FDA said there was a small, but real increased risk of suicidal behavior in adults and children taking these drugs.

The FDA had recommended monitoring all antidepressant users in March 2004 for signs of worsening depression or suicidal behavior, and later concluded that the drugs did add risk for children and teenagers. It then ordered manufacturers to place a warning on the labels of all antidepressants detailing those heightened risks reports Forbes.

Adults taking antidepressants (like Pfizer Inc.'s Zoloft, GlaxoSmithKline Plc's Paxil, Eli Lilly and Co.'s Prozac) should be closely monitored for signs of worsening depression or an increase in suicidal thinking or behavior, the FDA said. Patients should see a doctor if any of those problems occur.

"Close observation of adults may be especially important when antidepressant medications are started for the first time or when doses for the specific drugs prescribed have been changed," the FDA said.

Spokeswomen for Pfizer and GlaxoSmithKline said labels on their antidepressants already recommend close monitoring of all patients for any danger signs. The FDA said on its website that Eli Lilly's drug Cymbalta, authorised for use as an anti-depressant, had produced higher than normal levels of suicidal tendencies during clinical trials. Eli Lilly defended its product, saying that the 14 suicide attempts out of 12 000 people who took part in the trials was similar to the national average