FDA: Popular Diabetes Drug Linked to Heart Attacks

The U.S. FDA announced today that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia, according to the FDA website.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.”

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.

Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks.

“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

For more information about the new restrictions, see the FDA press release on Avandia.

To read more about diet and diabetes, see:
Can a Vegan Diet Cure Diabetes?

Top 10 Diabetes Superfoods

12 Common Diabetes Myths

62 comments

Summerannie M.
Summerannie M.10 days ago

Thank you for sharing.

Jeanne Rogers
Jeanne Rogers10 days ago

Thank you for sharing.

Duane B.
.3 years ago

Thank you for sharing.

Julie D.
Julie D.3 years ago

Pharmaceutical drugs scare the be-jeebus out of me, especially the newer ones. The potential side effects of most of them are far worse than the disease they are supposed to be treating. For example Statin drugs, which are given to help control high cholesterol, and thereby reduce the chance of heart attacks and strokes. However they cause the breakdown of your muscles, and your heart is a muscle. More people die of complications of pharmaceutical drugs and their inter-reactions in this country than all the illegal drug abusers combined and multiplied many times over. Scary stuff. But it is legal for big pharma to sell you these lethal drugs, while it is not legal to smoke a natural and relatively benign herb, marijuana. Ridiculous.

Penny C.
Penny C.3 years ago

Thanks for this important advice.

Aud Nordby
Aud nordby3 years ago

noted!Thanks for sharing.No drugs for me

Nimue Pendragon
Nimue Pendragon3 years ago

Good grief.

Michele Wilkinson

Thank you

Terry V.
Terry V.3 years ago

FDA FAILS again

Danuta Watola
Danuta Watola3 years ago

Thanks for sharing!