Grassley wants FDA to investigate Paxil
Pharma Compliance Alert, June 18, 2008
Senator Charles Grassley (R-IA) asked the FDA to scrutinize information GlaxoSmithKline (GSK) provided about its anxiety disorder drug Paxil, according to a Grassley release.
Grassley wants to know if GSK knew about Paxil’s suicide risk before it submitted the drug for FDA approval. Dr. Joseph Glenmullen, a professor of psychiatry at Harvard University, released a report accusing GSK of hiding Paxil’s suicide risk.
In addition, British Medicines and Healthcare products Regulatory Agency released its own report that determined GSK knew since 1998 of a higher risk of suicidal behavior linked to Paxil’s use in pediatric patients.
“The British counterpart to our country’s FDA found that GlaxoSmithKline withheld important safety data on Paxil,” Grassley said in the release. “If the company engaged in this behavior in the U.K., then I want to make sure that the same didn't happen here in the U.S. The FDA should investigate this question thoroughly and be forthcoming about its findings.”
If the FDA determines safety information was knowingly omitted from Paxil’s label, it could consider the drug to be misbranded under the Food, Drug, & Cosmetics Act.
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