Avandia: Even if FDA reverses restrictions, will diabetes drug make a comeback?

(CBS News) Avandia was the top-selling diabetes pill in the world, and then the Food and Drug Administration severely restricted its use after reports that taking the drug could raise the risk of heart attack and stroke.

But now, in a highly unusual move, the agency may reverse those restrictions.

FDA review: Avandia may not be as risky for heart as once thought

The controversy over Avandia began back to 2007 when Dr. Steven Nissen, a prominent cardiologist at the Cleveland Clinic, published an article in the New England Journal (of Medicine) showing there was a 43 percent increase of heart attack with Avandia, CBS News medical correspondent Dr. Jon LaPook explained on "CBS This Morning."

Two years later, GlaxoSmithKline, the drug company that makes Avandia, published its own study showing no increase in risk.

However, LaPook pointed out on "CTM," "There were a lot of people, including those within the FDA, who said the (GlaxoSmithKline study) was not a well designed study, so in 2010, the FDA votes to severely limit its use. And now, the FDA, at that time asked Glaxo(SmithKline) to fund an analysis -- a re-adjudication -- by an outside party at Duke (University) and they found no increased risk."

So does this mean if the FDA overturns those regulations, doctors will begin prescribing it again? LaPook said he doesn't think so. "You still have people who will say, 'You still have a study that was flawed. You're looking at the same flawed data again and you're getting the same conclusion'," he said on "CTM." "I think it's already plummeted in sales -- there used to be millions of prescriptions written a year -- $3 billion in sales (according to the Los Angeles Times and New York Times). Now about 3,000 people are taking the drug, so I think it's really kind of too late. There are other medications that treat diabetes well. I think it's not going to come back as a big drug."

For more with LaPook, watch his full interview above.

  • Amanda Cochran

Comments