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WASHINGTON - The antidepressant Paxil could raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the FDA warned Friday in a letter to doctors.
The warning letter was accompanied by changes to the labeling of both Paxil and Paxil CR, a controlled-release version of the drug.
An analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.
The FDA said there were 11 suicide attempts - none resulting in death - among the patients given Paxil in the trials. Just one of the dummy pill patients tried suicide.
Given that small number, the results "should be interpreted with caution," the FDA said.