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The FDA issued a statement today warning doctors of the increased risk of suicidal behavior in young adults taking the antidepressant Paxil.
The warning came after researchers at GlaxoSmithKline, the maker of Paxil, discovered a direct link between the antidepressant and suicidal behavior in adults. This is the first study conducted by a drug company to establish such a link.
The study reported that 11 suicide attempts were made by patients taking Paxil compared with only one by a patient taking a placebo. Of these 11 patients, eight were between the ages of 18 and 30. None of the suicide attempts resulted in death.
Previous studies had suggested that some antidepressants increased the risk of suicidal behavior in children and adolescents. This study, however, shows that the risk is serious for adults as well.
The FDA has urged doctors to carefully monitor patients taking the drug.
Glaxo said it has changed the labeling on Paxil to reflect the results of the study. All antidepressants are required to carry warning labels cautioning of the heightened risk of suicidal behavior.
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