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FDA Limits Diabetes Drug Even More FDA Limits Diabetes Drug Even More

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Health Care / HEALTH CARE

FDA Limits Diabetes Drug Even More

photo of Maggie Fox
May 18, 2011

The Food and Drug Administration has tightened restrictions on the diabetes drug Avandia, and said on Wednesday that it will stop sales of the drug in retail pharmacies.

“Health care providers and patients must enroll in a special program in order to prescribe and receive these drugs,” the FDA said in a statement.

The drug, made by pharmaceutical giant GlaxoSmithKline, was once tremendously popular but it has been linked to heart attacks and heart failure. U.S. and European regulators made a coordinated move last September to restrict access to Avandia.

 

The FDA limits the drug to patients already being successfully treated with it, or patients whose blood sugar cannot be controlled with other diabetes medicines and who do not want to take other related drugs.

Avandia, known generically as rosiglitazone, was a huge seller and Glaxo reaped $3 billion in 2006. Now most doctors have switched to Takeda Pharmaceutical's drug Actos, a rival in the same class of drugs.

There are several other classes of diabetes drugs, too.

“Health care providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines,” FDA said in a statement.

“After November 18, 2011, rosiglitazone medicines will no longer be available through retail pharmacies. Patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program.”

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