UPDATE 1-US senator seeks FDA probe of Glaxo's Paxil data
Thu Jun 12, 2008 11:56am
Senator seeks probe of Glaxo on Paxil data
WASHINGTON, June 12 (Reuters) – U.S. Sen. Charles Grassley asked U.S. regulators on Thursday to investigate whether drugmaker GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research)(GSK.N: Quote, Profile, Research) withheld data about a risk of suicide linked to its anxiety disorder drug Paxil.
Grassley, a Republican from Iowa, said in a letter that a British regulatory agency had found Glaxo knew Paxil was associated with a higher risk of suicidal behavior in adolescents as far back as 1998.
"I would like you to take a look at the information that agency gathered and determine if the company has withheld safety information here as well," Grassley wrote in the letter to the heads of the U.S. Department of Health and Human Services and the Food and Drug Administration.
Grassley also asked the FDA to review a report by a Harvard psychiatrist who has submitted information as part of several lawsuits. The report found Glaxo "had to know of Paxil's suicide risk when it sought FDA approval for the drug," a statement from the senator said.
FDA spokeswoman Sandy Walsh said the agency would review Grassley's request and respond to him.
A Glaxo spokeswoman could not immediately be reached for comment. (Editing by Dave Zimmerman)
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