Soon the popular diabetes medication Avandia will no longer be available on the shelves of drugstores, says the U.S. Food and Drug Administration. As an Atlanta injury lawyer, I am glad to see the drug off the shelves. In my opinion, the risk of serious injury appears too great. Formerly known asRosiglitazone, GlaxoSmithKline began marketing the product under the trade name Avandia in 1999, following initial approval by the FDA. Annual sales reached a high of $3.2 billion in 2006, but declined after reports of adverse effects. In fact, the drug has been plagued with liability issues ever since 2007 when a study was released by Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic. The study showed the drug increased risk of heart attack by 40 percent in people who had Type II Diabetes, prompting the FDA to require that it be packaged with a Black Box Warning.
Between 60,000 to 200,000 people suffered heart attacks and/or death, during the 11 year span that Avandia monopolized the market, and millions were prescribed the drug.
Beginning November 18, 2011, the drug will only be available through doctors who have fully disclosed the risks to their patients and are certified to prescribe it.Under the new Avandia-Rosiglitazone Medicines Access Program, the FDA will limit the drug’s use to patients who have already been safely treated with it, those whose blood sugar can’t be controlled with other medications and those who, when informed of the risk, still prefer Avandia to other drugs. Rosiglitazone will only be available to enrolled patients by mail order from certified pharmacies participating in the programand Avandia and Actos, which was approved in 1999, will be offered as its alternative.
Glaxo will start telling pharmacists and physicians about the new program within the 60 day window allowed by the FDA, and implement the changes at or before that time, said Mary Anne Rhyne, a company spokeswoman, in an e-mailed statement to Bloomberg News. Patients shouldn’t abruptly stop taking their diabetes medicines without first discussing it with their doctors, she said.
More than 23 million Americans are thought to suffer from Type II Diabetes.