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FDA: Popular Diabetes Drug Linked to Heart Attacks

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

Read more: Diabetes, Diet & Nutrition, Eating for Health, Fitness, General Health, Health, , , ,

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Melissa Breyer

Melissa Breyer is a writer and editor with a background in sustainable living, specializing in food, science and design. She is the co-author of True Food (National Geographic) and has edited and written for regional and international books and periodicals, including The New York Times Magazine. Melissa lives in Brooklyn, NY.

60 comments

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6:34AM PDT on Mar 14, 2013

Thank you for sharing.

10:41PM PST on Dec 3, 2012

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.

5:56PM PST on Dec 2, 2012

Thanks for this important advice.

3:58AM PST on Dec 2, 2012

noted!Thanks for sharing.No drugs for me

6:23PM PST on Dec 1, 2012

Good grief.

12:56PM PST on Nov 14, 2012

Thank you

12:53PM PST on Nov 14, 2012

FDA FAILS again

2:34AM PDT on Aug 14, 2012

Thanks for sharing!

6:53AM PDT on Aug 5, 2012

noted....

1:48AM PDT on May 25, 2012

I do my absolute damndest to avoid drugs of any kind. The side effects often far out weigh the benefit, if not in the short term, always in the long term. No disease is caused by a lack of medication(except for insulin in Type I Diabetes or other hormone replacements). I firmly believe the emphasis in healthcare should be on prevention not symptom treatment. Almost all cancer(except genetic) is some kind of longterm irritation to that specific body part where it originates. Liver cancer-too many toxins, skin cancer-too much sun, lung cancer-too much irritation from smoke, breast cancer is strongly linked to chemicals(parbens) in our personal care items and chemicals in the environment and food cause some kind of long term inflammation, this inflammation is almost always the cause of cancer, and the focus should be on reducing inflammation to prevent cancer. Not treatments for the sake of profiteers.

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Disclaimer: The views expressed above are solely those of the author and may not reflect those of
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