Avandia Pulled From Shelves Months After Dangers Known

The Food & Drug Administration announced last week that it will pull the diabetes drug Avandia and its sister medications Avandamet and Avandaryl from retail pharmacy shelves beginning in November.

After Nov. 18, only certified doctors will be able to prescribe the dangerous drug to patients who’ve been informed of its health risks. Then, Avandia or rosiglitazone prescriptions can only be filled by certified mail-order pharmacies.

“It’s like a decade-long nightmare coming to an end,” said Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic told USA TODAY.

What took so long?

Eleven years ago, Avandia’s manufacturer, then called SmithKline Beecham, knew the diabetes drug was dangerous, but made it anyway.

In 2007, Dr. Nissen, published a study that showed that Avandia (rosiglitazone) increased heart attack risk by about 40 percent in people with Type 2 Diabetes.

Eleven months ago, the Food & Drug Administration advisory committee recommended pulling Avandia from the shelves or tightening restrictions on its use, after learning it was responsible for increased heart problems, including stroke, heart attack and death, in 227,00 patients when compared to the alternative drug Actos.

Ten months ago, in July 2010, the New York Times published internal documents which exposed how SmithKline Beecham – now GlaxoSmithKline – covered-up Avandia’s heart risks. The FDA didn’t take action until September when it imposed stricter restrictions. Yet, Avandia was allowed to stay on the shelf.

The delay has only caused more harm.

 

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