NEWS ALERT

“The diabetes drug Avandia will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine.

The differing paths taken by European and American drug regulators reflect, in part, their differing powers. In Europe, drugs never gain permanent approval, and sales can rather easily be suspended. The F.D.A. does not have the power to give drugs conditional approval or to suspend sales. Restricted distribution programs, on the other hand, are becoming increasingly common in the United States but are rarely offered in Europe.

A study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.

Also on Thursday, the F.D.A. ordered GlaxoSmithKline to conduct an independent assessment of the Record trial, a landmark study of Avandia’s heart effects that an F.D.A. medical officer found was riddled with what he said were unpardonable errors that seriously biased the trial’s conclusions.

Senate investigators found that GlaxoSmithKline spent years hiding from regulatory authorities clear indications that Avandia increased heart risks.”

-The New York Times (full article)

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