Thursday, October 21, 2010

Avandia might cause heart patients: FDA

The U.S. Food and Drug Administration asserted that the type 2 diabetes mellitus drug Avandia, made by GlaxoSmithKline, is associated with increased heart risk like a condition similar to myocardial infarction (heart attack) and stroke.

The FDA will be discontinuing the use of Avandia, or rosiglitazone, to patients with type 2 diabetes mellitus.

Dr. David Graham, veteran drug safety examiner at the FDA, previously said, “There was no reason for the agency to keep the risky diabetes drug on the market, now that another drug Actos, which is in the same class, but much safer, compared to the Avandia.”

A study done by Dr. Steven Nissen, famous cardiologist at the Cleveland Clinic, did an examination and published the finding in 2007 at the New England Journal of Medicine, which associates usage of Avandia to 43 percent increased risk of heart attack and hospitalization for blocked coronary arteries.

The FDA on the other hand asks Glaxo to commission an independent re-adjudication of the controversial trial. This fact indicates the lameness of the report as stated by Dr. Nissen.

Dr. Nissen further added that the FDA restriction in association with the European ban of Avandia might prohibit the usage of drug by 99 percent.

Via : topnews

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