USA Today reports, “The diabetes drug Avandia [rosiglitazone] will be pulled from retail pharmacy shelves in November because it poses such a big heart attack risk, the federal government announced Tuesday.” Beginning Nov. 18, “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 who, informed of the risk, prefer this to other drugs.”
The Los Angeles Times “Booster Shots” blog reported that the drug “will be available by mail order only from selected certified pharmacies, and patients as well as physicians will have to undergo educational programs before it can be prescribed, the agency said.” The agency’s “action, implemented under the agency’s Risk Evaluation and Mitigation Strategy, applies not only to Avandia, but also to Avandamet (which contains rosiglitazone and metformin) and Avandaryl (a combination of rosiglitazone and glimepiride).”
Bloomberg News reports that Glaxo, the drug’s maker, “plans to 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 emailed statement.”
From the American Association for Justice news release.
