The Republican Senator from Iowa wants the agency to "carefully scrutinize" info from Glaxo after reviewing a report about suicide risks among adults using the antidepressant. Chuck has also asked the FDA to review findings released earlier this year by UK regulators, which charged the drugmaker with knowing about suicide risks in children since 1998, but failed to pursuecriminal charges.
The report cited by Grassley was prepared by Joseph Glenmullen, a Harvard psychiatry professor, for litigation in federal court in California over Paxil side effects. The report, which was unsealed earlier this year, asserts that Glaxo obscured suicide risks associated with Paxil for 15 years or more.
"The British counterpart to our country's FDA found that GlaxoSmithKline withheld important safety data on Paxil," Grassley says in a statement. "If the company engaged in this behavior in the UK, then I want to make sure that the same didn't happen here in the US. The FDA should investigate this question thoroughly and be forthcoming about its findings."