Our lawyers are investigating Avandia, a diabetes drug which may significantly increase the risk of a heart attack. A study to be published in the “New England Journal of Medicine” found that Avandia may increase cardiac risk. The journal’s editor, Dr. Jeffrey M. Drazen, is quoted as saying that, “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.”
This journal article does not necessarily mean that there is a products liability case against Glaxco, but the facts are emerging in a manner eerily similar to the Vioxx debacle. In fact, the finding that Avandia raises the risk of heart attack by 43 percent and aincrease the risk of heart-related death by 64 percent was based on a review conducted by Dr. Steven E. Nissen of the Cleveland Clinic, who was among the first doctors to raise questions about the cardiovascular risks associated with Vioxx.
The FDA has advised patients taking the drug, manufactured by GlaxoSmithKline, to seek advice from their doctor. The FDA intends to convene an advisory panel to investigate.
There is some question, however, whether the FDA is best suited to investigate. The New York Times reports that the FDA may have been aware of dangers associated with Avandia seven years ago. In a letter to the FDA on March 15, 2000, Dr. John B. Buse, chief of endocrinology at the University of North Carolina in Chapel Hill, who is about to become the president of the American Diabetes Association, expressed grave concerns about Avandia, citing “a worrisome trend in cardiovascular deaths and severe adverse events” among patients using the Avandia. Dr. Buse’s letter was also critical of the Glaxo’s marketing of Avandia, accusing the company of “pervasive and systemic” efforts to understate the Avandia’s risks and overstate its benefits.
Avandia, which has been on the market for seven years, is a big money maker for GlaxoSmithKline. Avandia is used by nearly a million people in the United States and two million people per year worldwide, for the treatment of Type 2 (adult-onset) diabetes. With $3.2 billion in worldwide sales last year, it was Glaxo’s second-biggest pharmaceutical product.