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WASHINGTON (AP) --
The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration 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, also called paroxetine.
A recent 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 reported that there were 11 suicide attempts -- none resulting in death -- among the patients who received Paxil in the trials. Just one of the dummy pill patients attempted suicide.
The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration 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, also called paroxetine.
A recent 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 reported that there were 11 suicide attempts -- none resulting in death -- among the patients who received Paxil in the trials. Just one of the dummy pill patients attempted suicide.