FDA: Diabetes Drug Avandia To Be Pulled From Retail Pharmacies In November

Image courtesy of One incredibly expensive drug for GSK.

For several years, prescription diabetes medicine Avandia has been at the center of a debate about whether the medication’s heart attack risk was high enough to pull it from pharmacies. Now, nearly eight months after the FDA announced it would be introducing strict restrictions on its sale and use, the agency has finally gotten around to announcing the specifics of those restrictions.

Starting Nov. 18, Avandia, along with other medicines containing the ingredient rosiglitazone, will no longer be available through retail pharmacies. It will only be available through certain mail order pharmacies.

Additionally, the drug will only be prescribed to patients who meet the following criteria: First, that they are currently being successfully treated by the drug. Second, that their blood sugar cannot be controlled with other anti-diabetic medicines.

Finally, the patient, the doctor prescribing Avandia and the mail-order pharmacy providing the drug must be part of the Avandia-Rosiglitazone Medicines Access Program.

In July 2010, an FDA advisory panel could not come to a consensus on how to handle the controversial drug. 12 panel members said it should be taken off the market; 10 said it should still be sold, but only with serious revisions to its labeling and possible restrictions on its sale; 7 members were fine with just adding some more warnings to the drug’s labeling; 3 said it should continue to be sold as is.

FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl [FDA.gov]

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