Paroxetine and Suicide Risk
GlaxoSmithKline and the FDA have warned doctors that the antidepressant paroxetine (Paxil) may raise the risk of suicidal behavior in young adults. The letter was accompanied by changes to the labeling of both Paxil and controlled-release Paxil Drug.
A recent analysis of data on nearly 15,000 patients revealed a higher frequency of suicidal behavior in young adults who used the drug. The FDA reported 11 suicide attempts—none resulting in death—among the patients in the trials. Only one patient receiving placebo attempted suicide.
Given that small number, the results “should be interpreted with caution,” the FDA said. In eight of the 11 attempts, the patients were between 18 and 30 years of age. All of the patients in the trial had psychiatric disorders, including major depression.
All patients who use paroxetine generic, especially young adults and those whose symptoms are improving, should be carefully monitored.
