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Thursday, June 12, 2008

Senator seeks probe of Glaxo's Paxil data

Source: Reuters

June 12

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.



"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"

Good luck mate... you may want to ask them why it took them four years to investigate while you are at it and why they never made no arrests!




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