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Friday, February 22, 2008

GRASSLEY RECEIVES GSK'S PAXIL DOCUMENTS, BUT HIS CONCERNS REMAIN

Source: Theraputics Daily

A spokeswoman for Sen. Charles Grassley (R-IA) says documents submitted by GlaxoSmithKline on its drug Paxil have, at first glance, not alleviated the lawmaker's suspicions that GSK knew about increased suicide risks associated with the antidepressant years before it sent a 2006 warning letter to physicians.

"Our concerns have not changed," says spokeswoman Jill Kozeny.

The lawmaker received a tall stack of papers from GSK the day after his deadline for the company to submit documents on Paxil. Kozeny says Grassley's staff is going through the documents this week and declined to comment on the next steps Grassley might take.

A magazine article had sparked his interest in trying to pinpoint when GSK knew about elevated risks that were not detected during the premarket review of the drug (see FDA Week, Feb. 8). GSK says the researcher who claims the company knew of the higher suicide risks at an earlier date has incorrectly analyzed the data.

Grassley also launched an investigation recently into Merck's cholesterol drug Vytorin. House Energy and Commerce Committee leaders are conducting a similar investigation.

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