The Food and Drug Administration issued a new warning that adults taking antidepressants should be closely watched for suicidal tendencies, citing publications that suggest an increased risk among patients taking the drugs. The advisory, posted last night 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. In March 2004, the FDA asked that several antidepressants get labels noting that all patients should be watched closely for signs of increased depression or suicidal leanings. Later, the agency called on manufacturers to add a strong "black box" warning about the link between the drugs and suicidal tendencies in children. The FDA wanted to "highlight" the concern about adults, said Steven Galson, acting director of the agency's drug center. The FDA is doing a major review of data on adult antidepressant patients to evaluate whether the drugs increase the risk of suicidal tendencies. 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. Other drug makers couldn't be reached. The warning is the latest sign of FDA's increasingly aggressive approach to making safety information public.
