Avandia Recall Hits the U.S.
Glaxo’s Diabetes Drug Avandia Pulled From U.S. Pharmacies
Avandia will be pulled from U.S. pharmacies in November and available only through a special program, the FDA said.
The restrictions are part of a risk mitigation strategy established in September with a medication guide to limit the use of Avandia after data suggested patients had a higher chance of heart attacks. The drug and combination therapies containing it will no longer be available in retail pharmacies starting Nov. 18, according to the FDA, which is requiring doctors and patients to enroll in a program to prescribe or take them.
Avandia, once the world’s best-selling diabetes bill at $3 billion in annual revenue, generated $680 million in sales last year for London-based Glaxo. About 460,500 patients filled a prescription for Avandia, Avandamet or Avandaryl at a retail pharmacy from January to October 2010, the FDA said.