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FDA Limits Use of Diabetes Drug Avandia

Thursday, 19 May 2011 08:23 AM

GlaxoSmithKline’s diabetes drug Avandia will be pulled from U.S. pharmacies in November and available only through a special program, the Food and Drug Administration 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 pill 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 in a safety announcement posted today on its website.

“Healthcare providers and patients must be enrolled in the Avandia-rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines,” the agency said, using the chemical name for the drug. Patients will receive their medicines through specially certified mail-order pharmacies, the agency said.

Glaxo 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 e-mailed statement. Patients shouldn’t abruptly stop taking their diabetes medicines without first discussing it with their doctors, she said.

The drugs can be used only by patients who are already taking them successfully and who can’t control their blood sugar levels with other diabetes drugs, including Actos from Osaka, Japan-based Takeda Pharmaceutical Co., the FDA said.

Use of the medication has fallen by half during the year, with 235,500 patients filling a prescription in January and 119,000 getting the drugs in October, the agency said.


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2011-23-19
Thursday, 19 May 2011 08:23 AM
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