FDA Panel Recommends Restricting Avandia

Regardless of the unknown risk of death, stroke or heart attack, many members thought the increased risk of congestive heart failure and fractures in women, along with Actos as a class alternative, was enough to suggest that the risk outweighed the benefits of Avandia.

"Remember, we're not getting rid of the class, we're just thinking about that one drug," Rosen said.

In a written response to the FDA Advisory Committee's recommendations, Avandia's maker GlaxoSmithKline said the studies available showed that Avandia is safe and effective, "when used in the appropriate patient and in accordance with labeling."

"Following today's recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease," said Dr. Ellen Strahlman, drugmaker GlaxoSmithKline's Chief Medical Officer, in the written response.

FDA Decision Catching Up to the Norm, Some Experts Say

Avandia's safety was first publicly called into question in 2007 when an analysis by Dr. Steve Nissen, chair of cardiovascular medicine at the Cleveland Clinic, found that those on the drug had a 43 percent higher risk of heart attacks and a 64 percent higher risk of dying from heart disease.

More recently, Food and Drug Administration associate director of drug safety Dr. David Graham called for Avandia to be removed from the market in a February report. He said the drug could be linked to about 500 more heart attacks and 300 more cases of heart failure each month than would occur if its competitor, Actos, were used exclusively.

Panel member Dr. John Teerlink said that compared to 2007, it's clear that Actos is a stronger drug than Avandia. But, Teerlink said, perhaps it's not necessary to pull the drug from the market but let the drug die on its own.

"Maybe the marketplace will drive the bad drug out when the good drug comes in," he said.

Some experts did not wait for an official FDA vote before deciding to stop prescribing Avandia to many of their patients

"For my patients on Avandia, many of them have already asked to be switched to Actos," said Dr. Andrew Carroll, a family physician based in Chandler, Ariz.

"Based on prior studies I had read, I stopped prescribing Avandia about two years ago, and have been sticking with Actos," he added, saying that until the FDA makes a recommendation or further studies prove the drug is safe, he will be steering clear of Avandia.

Dr. Neil Brooks , a primary care physician in Vernon, Conn., said he hasn't prescribed Avandia for many years after many of his patients experiencing weight gain, and even heart failure.

But while the drug may be dangerous to some patients, he said, they should understand that there are alternative diabetes treatments that may fare better for their health.

"Simply giving the public the message that this stuff you have been taking for 10 years is possibly causing you harm will further erode the public's trust in both the pharmaceutical and medical systems," Brooks said. "It would be far better to say that after prolonged evaluation it has been found that alternative therapies have improved outcomes and the less-effective treatments will be withdrawn."

Dr. Eric Larson, executive director of Group Health Research Institute, said he does not prescribe Avandia and even cancelled a research study on the drug after earlier reports of the drug's toxicity.

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