Is Avandia Going the Way of Vioxx? Popular Diabetes Drug May Raise Risk of Fatal Heart Attacks

Oh no! Another nightmarish consequence of taking drugs!

The safety of Avandia™ -- often prescribed to type 2 diabetics -- has been called into question by an eye-opening, scathing scientific article in today's New England Journal of Medicine. which finds, from reviewing 42 clinical trials, that the popular drug may raise the risk of heart attacks by 43 % and cardiovascular death by a whopping 64%.

The lead author of the original article is the respected Steven Nissen, M.D., chairman of the Department of Cardiovascular Medicine at the renowned Cleveland Clinic, and immediate past president of the prestigious American College of Cardiology. (Read his bio here.)

Avandia -- also known as rosiglitazone -- is widely used to help type 2 diabetics lower their blood glucose levels, and it is a $3 billion-a-year business now at risk of being drastically curtailed.

"Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease," said Dr. Nissen in a press release from the Cleveland Clinic.

Every news outlet was full of different takes on these scary conclusions.

• Stephanie Saul of the New York Times weighed in with an enlightening piece, in which she noted that Dr. Nissen was "one of the first doctors to raise questions about the cardiovascular safety of Vioxx, the Merck painkiller that was withdrawn from the market in 2004. His concerns about Avandia were first publicly raised last December in a letter in the Lancet."
• Julie Steenhuysen of Reuters pointed out that a congressional committee has already scheduled a hearing on the drug's safety. "Both the drug company and the FDA have some major explaining to do about what they knew about Avandia, when they knew it, and why they didn't take immediate action to protect patients," the reporter quotes Montana Democrat Sen. Max Baucus, who chairs the Senate Finance Committee.
• Meanwhile, Marilynn Marchione of AP noted that although FDA officials issued a safety alert Monday, they "planned no immediate changes to the current side effect warnings on the drug's packaging." She reports that Rep. Henry Waxman, D-Calif., chairman of the House Committee on Oversight and Government Reform, announced a hearing for June 6 on the FDA's role. She writes: And on the Senate floor, Charles Grassley, R-Iowa, "criticized the agency for not acting more swiftly. "Do we have another Vioxx on our hands with Avandia? I am not sure, but I intend to find out," he said.
• Then, Seve Sternberg of USA Today talked about how nine months ago risks had been raised about the drug in an article with the alarming, but appropriate headline, "Diabetes drug called potential death risk."
• Meanwhile, TIME magazine's Jyoti Thottam offered a compelling overview of the scare and raised some pressing questions in an article entitled, "Is Avandia the next Vioxx?" She points out that Dr. Nissen told TIME that he began looking into Avandia because he was concerned by data from two of the largest studies of diabetic patients taking the drug. "The cardiovascular events were all going the wrong direction," he told the reporter. She writes: "Though the results weren't statistically significant, they pushed him to look at other data sets, including studies by the FDA and from the clinical-trials registry on GlaxoSmithKline's website. Nissen had gathered his data by April 24, and six days later submitted the paper to the Journal's editors."

You now can check out the FDA and drug-maker's responses.

• Here's the safety alert that the FDA rushed to issue.
• And now you can read GlaxoSmithKline's response to the NEJM's article.

More tomorrow on this new Avandia scare.

Coming up: Why don't we hear more about research and success stories, which definitely show that reducing or cutting out high-glycemic carbs (sugar and processed grains) and exercising may be the most effective ways to manage type 2 diabetes?