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Diabetes Drug Avandia Raises Heart Disease, Death Risk

by VR Sreeraman on  February 23, 2010 at 1:44 PM Drug News   - G J E 4
 Diabetes Drug Avandia Raises Heart Disease, Death Risk
US senators have linked a diabetes drug to heart disease and death.
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They have claimed that the drug Avandia used by tens of thousands of Britons increases the risk of heart problems and could even lead to death, reports the Telegraph. The US Food and Drug Administration (FDA), the medicines safety watchdog, has urged an advisory committee to verify the safety of Avandia.

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The British counterpart, the MHRA, said it is "continuously monitoring" the safety of the drug.

In a report, senators Max Baucus and Charles Grassley alleged that the FDA had not banned the drug because it was too "cozy" with drugs firms.

They quoted a memo written by two FDA reviewers, which concluded: "The risks of (Avandia) are serious and exceed those for rival drug Actos."

There was "strong evidence that (Avandia) confers an increased risk of" heart attack and heart failure when compared to Actos, the reviewers said.

A 2007 study, published in the Journal of the American Medical Association, showed that Avandia puts users at a 60 per cent greater risk of heart failure and a 29 per cent greater risk of death than other medication.

"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drugs companies with their health and their lives," the Telegraph quoted Senator Baucus as saying.

However, a GSK spokesman said it dismissed the report's conclusions.

The report "cherry-picks information from documents, which mischaracterises GlaxoSmithKline's comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients," the company said.

The company said that it had rigorously studied Avandia's safety and "consistently shared this data with regulators around the world".

GSK said that it "does not condone any effort to silence scientific debate".

Source: ANI
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