Sunday, May 27, 2007

Sen. Grassley Says FDA Study Also Shows Avandia Risk

Article in the Washington Post -- FDA Study Said to Show Avandia Risk, by Marilynn Marchione.  Here's an excerpt:

The government's own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress said Thursday.

In a floor statement placed in the Senate record, Sen. Charles Grassley also said that safety watchdogs within the federal Food and Drug Administration "several months ago" recommended a "black box" on the drug's label _ the strongest possible warning.

It is the first confirmation that the FDA's own analysis of Avandia shows a similar magnitude of heart attack risks _ dangers that were first publicly raised in a medical journal report published earlier this week.

Grassley complained that FDA higher-ups have said they want to wait for results of an ongoing study that will not be available for two more years before making a decision.

BGS

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