U.S. FDA: Paxil Needs Suicide Warning
CBSNews.com - May 15, 2006
The antidepressant Paxil (paroxetine) has been indicated in increasing the risk of suicidal behavior in young adults. The Food and Drug Administration and drug maker GlaxoSmithKline have sent a letter to doctors informing them of the risk.
Both Paxil and Paxil CR will have changes made to their labeling. A clinical trial done on nearly 15,000 patients given Paxil and a placebo showed a higher incidence of suicidal behavior in young adults treated with the drug.
GlaxoSmithKline PLC continues to believe Paxil's benefits outweigh its risks, but The FDA stressed that all patients taking the drug need to be closely monitored.
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