FDA puts heavy restrictions on Avandia

Share this article:

The Food and Drug Administration announced Wednesday that effective Nov. 18, 2011, Avandia will be pulled from retail pharmacy shelves due to the diabetes drug's cardiovascular threat to patients.

A 2007 analysis conducted by the Cleveland Clinic cardiologist Steven Nissen, M.D., found that those with type 2 diabetes who took Avandia (rosiglitazone) had a 40% increase in heart attack risk. Several other studies confirmed the risk.

Starting Nov. 18, only certified doctors will be able to prescribe the drug, and only to patients who have been alerted to the risks, who have already taken the drug safely, and who have found that other medications did not control their diabetes. These patients can obtain Avandia through mail-order pharmacies.

Several cardiologists have criticized the FDA for failing to act sooner.

"It's like a decade-long nightmare coming to an end," Nissen told USA Today. "Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it."

Share this article:

More in News

Hospitals in the Midwest refer patients to the broadest networks of skilled nursing facilities, study finds

Hospitals in the Midwest refer patients to the ...

Midwestern hospitals spread referrals to the greatest variety of skilled nursing facilities and tap their favorite SNFs least often, according to a recently published analysis of nationwide referral patterns.

Bill would affect pay, scheduling for some nursing home housekeeping staff

Nursing homes could face more stringent scheduling requirements for housekeeping workers and might be on the hook to compensate them for last-minute shift changes under a bill proposed in both houses of Congress.

Joint Commission adds memory care accreditation

New memory care accreditation for nursing homes encourages staff to use a flexible, problem-solving approach to care for those with dementia, according to Joint Commission guidelines.