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–August 5, 2005
Paxil, generic name paroxetine, is a blockbuster antidepressant drug by GlaxoSmithKline that has raised concerns in the past because of its suicidal side effects. The U.S. Food and Drug Administration requires all antidepressants to carry warnings about the increased risk of suicide to children and teenagers, and on June 30, the agency said it was conducting a review of available data to determine whether there is an increased risk of suicidal thinking in adults who are taking antidepressants.
Though the FDA said it expects to take at least a year to complete this review, a report by Norwegian researchers published in BMC Medicine on Aug. 22 concluded "Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may well be present also in adults." The analysis of trials for Paxil involving more than 1,500 people found that patients taking Paxil attempted suicide seven times, compared to one suicide attempt in placebo studies.
The researchers added, "we also conclude that the recommendation of restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults." GlaxoSmithKline called the study "misleading," criticizing the study for causing unnecessary confusion and concern for Paxil and other antidepressant users.
Paxil is a $1.9 billion drug.
If you or a loved one has experienced serious side effects from antidepressants, please contact us to learn your legal rights.