Some dermatologists have prescribed the anti-depressant drug, Paxil, for “off-lable” use in teenagers. One of those teenagers, a 16 year old from New Jersey, killed himself shortly after he began the Paxil regime. The parents of the teen brought a lawsuit against Glaxo-SmithKline (GSK), claiming that the drug firm was negligent in failing to warn doctors about the risk of suicide that the drug posed to children and adolescents.GSK sought to have the case dismissed, claiming that the FDA did not require such a warning since the drug was never approved for pediatric use. A federal judge in Philadelphia has ruled that the suit could go forward because there was no evidence that the FDA has specifically considered, and rejected, the need for a warning about pediatric suicide with Paxil. The court noted that the negligent failure to warn claim “closes the void” in the FDA which can neither independently regulate off-lab uses or require additional clinical trials of a drug. Knipe v. SmithKlineBeecham, 2008 WL 4442635 (E.D.Pa.)
