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Avandia Diabetes Drug Linked To Heart Attacks

According to an article in the New York Times today, the popular dates drug Avandia has been linked to an increased risk of heart attacks. The Times article quotes from the New England Journal of Medicine. Here are excerpts from the article:

An article released today by The New England Journal of Medicine raised safety questions about the widely-used diabetes pill Avandia. An analysis of clinical trials concluded that the drug might significantly increase the risk of heart attacks.

The journal’s editor, Dr. Jeffrey M. Drazen, said: “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.”

While noting possible weaknesses in data used in the analysis, an accompanying editorial calls for a Food and Drug Administration review and questions why physicians would prescribe Avandia, which is made by the British pharmaceutical company GlaxoSmithKline and known generically as rosiglitazone.

“In view of the potential cardiovascular risks,” the editorial said, “and in the absence of evidence of other related advantages, except for laboratory measures of glycemic control, the rationale for prescribing rosiglitazone at this time is unclear. ” The editorial cautioned patients not to stop taking the medication without discussing it with their doctors.

Dr. Drazen said patients concerned about the drug should meet with their doctors to decide whether to remain on it or switch to another drug.

Avandia, on the market since 1999, is used by nearly two million people a year worldwide, including a million in the United States, for the treatment of Type 2, or adult-onset, diabetes. With $3.2 billion in worldwide sales last year, it was Glaxo’s second-biggest product.

The finding — that Avandia raises the risk of heart attack by 43 percent — was based on a review of 44 studies of the drug. The review was conducted by Dr. Steven E. Nissen and Kathy Wolski of the Cleveland Clinic, where Dr. Nissen is the chief of cardiovascular medicine.

Dr. Nissen was among the first doctors to raise questions about the cardiovascular safety of Vioxx, the Merck painkiller that was withdrawn from the market in 2004.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.

Dr. Nissen’s letter noted increased cardiovascular problems in a 5,000-patient clinical study, called Dream. GlaxoSmithKline had sponsored the Dream trial in an effort to expand the product beyond a treatment for diabetes by using it to prevent the disease.

In the Dream trial, patients taking Avandia had 66 percent more heart attacks, 39 percent more strokes and 20 percent more deaths from cardiovascular-related problems. That outcome, Dr. Nissen wrote, “virtually precludes the possibility of an overall benefit and suggest an unexpected mechanism for harm.”

Results from another trial, Adopt, published in December, also indicated an elevated risk of heart problems compared to another diabetes drug.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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