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WASHINGTON, Jul 01, 2005 (United Press International via COMTEX) -- The U.S. Food and Drug Administration has warned adults taking antidepressants should be closely watched for suicidal tendencies.
The advisory, posted on the FDA Web site, goes further than the agency has before in flagging a potential tie between the drugs and suicidal tendencies in adults, the Wall Street Journal said Friday.
The FDA is doing a major review of data on adults to evaluate whether the drugs increase the risk of suicide.
A spokeswoman for Pfizer Inc., maker of the antidepressant Zoloft, said the drug's label already reflects the "need for close patient monitoring." Wyeth, maker of Effexor, said the latest recommendations "are very much in keeping" with the drug's label.
The warning is the latest sign of FDA's increasingly aggressive approach to making safety information public.
The FDA also posted information about patients who displayed suicidal tendencies during trials of one antidepressant, Eli Lilly's Cymbalta, being tested for stress-related urinary incontinence.
Copyright 2005 by United Press International.
