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Avandia: GlaxoSmithKline Accused Of Covering Up Heart Risks

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Avandia: GlaxoSmithKline Accused Of Covering Up Heart Risks

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Avandia May Be Recalled

admin » 09 July 2010 » In Defective Products, FDA, Legal News, Mass Tort, Recall » No Comments

Avandia May Be Recalled

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 Food and Drug Administration 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.

FDA scientists reviewed dozens of studies of Avandia, including one which Glaxo has pointed to as proof of the drug’s safety. But an FDA reviewer said the study was plagued by “serious flaws” and actually supports the case against Avandia.

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

Source

New risks that may be associated with the diabetes drug Avandia

The European Medicines Agency said the drug was authorized for use but with warnings about prescribing for patients with heart failure or a history of heart failure, or to patients with heart problems.

Two years ago, the European committee, known as CHMP, concluded that the drug “retained a small, if diminishing, place in diabetes Type 2 therapy.”

A study published in the United States last month linked Avandia to a higher risk of heart problems, strokes and deaths in older adults, and called it more dangerous than a rival drug, Actos.

As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, said Dr. David Graham, lead author of the study and a scientist for the FDA. He wants the pill banned.

Source

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