Quoted from http://www.nytimes.com/2013/06/03/business/second-thoughts-on-safety-of-avandia-stir-a-dispute.html
F.D.A. to Reconsider Restrictions on Diabetes Drug
By KATIE THOMAS and SABRINA TAVERNISE
Published: June 2, 2013
Three years ago, in one of the more notable drug-safety scandals in recent history, the diabetes drug Avandia was all but banned from use in the United States after researchers found that thousands of people had heart problems after taking it. Today, it is a drug of last resort for people with diabetes who are so sick that a heart attack is worth the risk.Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, was the first to sound a public alarm about Avandia, as early as 2007.
But now, in a highly unusual move, the Food and Drug Administration has decided to reopen the case on Avandia and will ask a panel of experts this week whether the agency must reconsider the restrictions on the drug.
That is just one of several options before the advisory committee, but lifting the limits would amount to a major policy reversal and could be a huge victory for the drug’s maker, GlaxoSmithKline. Avandia was once a top-selling drug, reaching more than $3 billion in sales in 2006 before controversy flared. It could also help rewrite one of the most embarrassing chapters in the F.D.A.’s recent history.