Avandia (Drug)
Avandia (Drug)
Stephanie Saul Aug. 31, 2007
New York Times
Avandia is a widely used pill for Type 2 diabetes. Like a similar drug, Actos, it works to control blood sugar by increasing the body’s sensitivity to insulin. Avandia is often taken as part of a regimen that includes other diabetes medications.
It has been sold in the United States since 1999, when it was approved by the Food and Drug Administration as a safer alternative to Rezulin, a drug for Type 2 diabetes that was banned because it caused liver problems. Avandia was heavily marketed and quickly became one of the biggest selling products manufactured by GlaxoSmithKline. In 2006, sales of Avandia were $3.4 billion.
Concerns that Avandia increases the risk of a heart attack were widely publicized in May 2007 in an article in The New England Journal of Medicine. The article's lead author, Dr. Steven E. Nissen of the Cleveland Clinic, estimated that users of Avandia faced a 43 percent higher risk of a heart attack or other cardiovascular events. Other doctors raised questions about whether Avandia should remain on the market, some citing data suggesting that Actos, which is manufactured by Takeda Pharmaceuticals, did not appear to carry the same risks.
Dr. Nissen’s findings were based on the results of a meta-analysis, a compilation of studies. GlaxoSmithKline, a major pharmaceutical company based in London, disputed Dr. Nissen’s conclusions and released preliminary results of its own study that did not show significantly increased risks among users of the drug.
The debate highlighted internal dissension at the Food and Drug Administration. GlaxoSmithKline had presented data similar to Dr. Nissen’s findings to the F.D.A. in 2005, but the agency did not take action or inform the public because of disagreements among officials about the importance of the data.
Following Dr. Nissen’s article, the Food and Drug Administration convened a special advisory panel to review the drug’s safety risks. The panel met July 30, 2007 in Gaithersburg, Md. But after reviewing Dr. Nissen’s findings, as well as other data, panel members concluded that the evidence was too murky to warrant removing Avandia from the market, voting 22-1 to recommend that it remain available.
Sales of the drug plunged, however, and it was not clear whether Avandia would ever regain the popularity it once had. In a related decision, the F.D.A. decided to stengthen labels on Avandia and Actos warning that patients using the drugs should watch for fluid accumulation in the legs, ankles and lungs that could lead to heart failure.
Copyright 2008 The New York Times Company
