FDA, GSK Warn Doctors of Paxil Risks
FDA and GlaxoSmithKline on Friday in a letter to physicians warned that the antidepressant Paxil could increase risk for suicidal behavior in young adults, the AP/Long Island Newsday reports. In addition, GSK on Friday revised the labels for Paxil and Paxil CR, the controlled-release version of the medication, to include a warning about increased risk for suicidal behavior.
The actions follow an analysis of data from clinical trials that involved nearly 15,000 participants with psychiatric disorders who received Paxil or a placebo.
The analysis found a higher rate of suicidal behavior in young adults who took Paxil. According to the analysis, 11 participants who took Paxil attempted suicide, compared with one who took a placebo, and eight of the 11 suicide attempts involved participants between ages 18 and 30.
GSK spokesperson Mary Anne Rhyne said the company released the results of the analysis after FDA requested that manufacturers of antidepressants examine their trial data for a potential link between the medications and increased risk for suicidal behavior in adults.
John Kraus, GSK director of clinical development for clinical psychiatry in North America, said in the letter that the company continues to believe that the benefits of Paxil outweigh the risks.
FDA said that physicians should carefully monitor patients who take Paxil (AP/Long Island Newsday, 5/13).