- The Washington Times - Tuesday, May 22, 2007

The widely prescribed diabetes drug Avandia is now linked to a greater chance of heart attacks and heart-related deaths, according to a study published by the New England Journal of Medicine in its online edition yesterday.

The Food and Drug Administration issued a safety alert yesterday, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC.

Robert Meyer, director of the FDA’s Office of Drug Evaluation, yesterday acknowledged the findings pointed to a “potential risk,” but emphasized that the FDA has other data that have been “contradictory” to information that shows Avandia induces a higher risk of heart attacks.

“There is not constant-enough data to make a firm conclusion about the risk. We don’t have a recommendation, given the data available to us,” Dr. Meyer said.

People taking Avandia with a history of heart trouble should talk to their doctors about the results of the study in the journal, he added.

The journal yesterday published the results of a multitude of studies that revealed a 45 percent greater risk of heart attacks in people taking Avandia. More than 6 million people with Type 2 diabetes worldwide have taken the GlaxoSmithKline drug since it was introduced eight years ago.

Among patients taking Avandia, 86 had heart attacks, compared with 72 among patients not on the drug. In addition, 39 patients taking Avandia died from cardiovascular causes, compared with 22 patients not receiving the drug, the article says.

The primary author of the study raised the question of whether the FDA properly approves the safety of diabetes medications.

“These emerging findings raise an important question about the appropriateness of the current regulatory pathways for the development of drugs to treat diabetes,” said Steven Nissen, the chairman of cardiology at the Cleveland Clinic in Ohio.

GlaxoSmithKline immediately protested Dr. Nissen’s assessment, saying that the results of his work “are based on incomplete evidence and a methodology that the author admits has significant limitations.”

Avandia is the top-selling oral diabetes drug in the U.S. It works by sensitizing the body to insulin and was considered a breakthrough medication for blood-sugar control. Avandia competes with Merck & Co’s, Januvia, and with Actos, a drug made by Japan’s Takeda Pharmaceutical Co.

Nearly 21 million people in the U.S. have diabetes, with Type 2 accounting for 95 percent of those cases.

Congress, growing uneasy with the number of health complications caused by prescription drugs and foods over the last several years, lashed out at both the drug company and the FDA after the release of the article.

“What we are learning about the handling of Avandia by both GlaxoSmithKline and the FDA is appalling and unacceptable,” said Sen. Max Baucus, Montana Democrat and chairman of the Senate Finance Committee. “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.”

In August 2006, GlaxoSmithKline submitted data to the FDA that showed an increased risk of heart trouble. But Dr. Meyer said the company’s study was not done well enough for the agency to take action.

“We’ve tried to weigh the risks of going forward with an uncertain message and make people switch therapies, which means less control of diabetes, with the level of uncertainty about the safety signal before us. We’re in a position of looking at this internally very hard and come to a better recommendation if there is a need for specific regulatory action.”

The FDA is in the last stages of completing a reanalysis of the data given to the agency by GlaxoSmithKline last year. When the reanalysis is complete, the agency will convene an advisory committee of physicians with expertise in diabetes to recommend whether regulatory action should be taken. Dr. Meyer said an advisory committee should be set in a couple of months.

Current labeling for Avandia explains some increased risk for heart problems in people with underlying heart trouble.

“It did not seem like there was anything else we could say,” Dr. Meyer said.

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