Glaxosmithkline PLC’s once best-selling diabetes drug Avandia may face new restrictions and even a possible recall by the FDA this week. Last week Bloomberg News reported that almost 50,000 elderly Americans died, suffered strokes or developed heart failure after taking Avandia, according to a drug safety reviewer at the FDA.
Need to Know’s Alexandra Nikolchev spoke with Dr. Steven Nissen, a prominent heart specialist and chief of cardiovascular medicine at the Cleveland Clinic, one of the leading heart clinics in the world. In 2007, Nissen and coauthor Kathy Wolski analyzed data from 42 clinical trials of Avandia, and found Avandia patients were 40 percent more likely to have a heart attack or be hospitalized for blocked coronary arteries than patients not using Avandia. His findings were first reported in The New England Journal of Medicine. Despite a growing body of evidence linking the drug to heart problems, Avandia remains on the market and continues to be prescribed for people with diabetes.
Need to Know will be following up on this story as it develops in the coming weeks.
Avandia on Trial [Forbes.com]