FDA review spotlights heart risk of diabetes pill Avandia

[Bozita]

Source: AP

Last Updated: July 09. 2010 11:30AM
FDA review spotlights heart risk of diabetes pill Avandia
Matthew Perrone / Associated Press

Washington -- A review by federal health scientists reinforces potential ties between the diabetes pill Avandia and heart attack and death, opening the door for government action, including a possible withdrawal of the once blockbuster drug.

The FDA posted an exhaustive 700-page review of the GlaxoSmithKline drug online Friday ahead of a meeting next week to review the safety of Avandia, which is used by hundreds of thousands of diabetics in the U.S.

The FDA holds a special two-day meeting starting Tuesday to help decide what course of action to take. A panel of outside expert physicians will vote on a range of recommendations for Avandia including:
• adding additional warning labels
• limiting which doctors can prescribe the drug
• pulling the drug from the market

The FDA is not required to follow the advice of its outside panels, though it usually does.

Read more: http://www.detnews.com/article/20100709/LIFESTYLE03/7090423/1361/FDA-review-spotlights-heart-risk-of-diabetes-pill-Avandia#ixzz0tCprvK3v

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Here's the NYT piece on the same topic:



F.D.A. Disputes Finding That Avandia Is Safe
By GARDINER HARRIS
Published: July 9, 2010


WASHINGTON — The drug maker GlaxoSmithKline misinterpreted crucial details of a study finding that Avandia, its blockbuster diabetes drug, is safe, a medical reviewer for the Food and Drug Administration said Friday.

Correctly interpreted, the study actually supports critics’ contentions that Avandia may cause heart attacks, said the reviewer, Dr. Thomas Marciniak, in a posting on the F.D.A.’s Web site.

The company’s misreadings of the study, known as the Record trial, were so profound, he concluded, that they “suggest serious flaws with trial conduct.”

“One does not have to be a mathematician or to perform calculations,” he wrote, to come to the conclusion that a combined look at all the trials of Avandia would demonstrate that it causes heart attacks.

more ...

http://www.nytimes.com/2010/07/10/health/10diabetes.html?_r=1&hpw

[glinda]

1. Majority of drugs on the market are failures IMHO.