FDA to pull Avandia from pharmacy shelves

May 19, 2011 2:23:35 PM PDT
The FDA has put another roadblock in the use of the diabetes drug, Avandia. The once widely used drug will now have some very strict limitations on its use.

Five years ago Avandia was one of the most popular diabetes drugs in use with over a million Americans taking it to control their Type 2 diabetes. Nowadays, maybe a tenth of that number still uses it, and that number is likely to drop because of new actions from the Food and Drug Administration to limit its access.

After November, Avandia will no longer be available at local pharmacies. Patients who have a prescription for it will have to get it by mail-order from specially approved pharmacies.

Both patients and physicians will have to undergo an educational program before it can be prescribed, and there will be a national registry.

Dr. Leonid Poretsy feels that these new rules will cause conflicts between patients and doctors who may not be on the same page with the restrictions.

"Even if the doctors think it's the best solution, the patients may not want it," Dr.Leonid Poretsy said. "They can still get it, but they get anxious, even as we try to explain all the data.

This was the case with Adam Friedman, a diabetes patient who successfully took Avandia for over a decade until Dr. Steven Nissen at the Cleveland Clinic published a review which claimed that patients who took Avandia were at a higher risk for heart problems.

Not all doctors agreed with Dr. Nissen's findings, which made Avandia a controversial drug. This led to the FDA putting a "Black Box Warning" on the drug.

Friedman was concerned, but more confused after talking to his doctor because he didn't find the evidence to be that compelling. However, Friedman's concerns were enough for his doctor to take him off Avandia.

Friedman is now on a different drug called Actos. Although this drug has been successful for him, it comes with its own risks.

Dr. Gerald Bernstein, who has over 40 years experience in diabetes care, has mixed feelings about Avandia's new restrictions.

"Most people with Type 2 diabetes are treated by primary care physicians, so it's not likely that Avandia will be prescribed," Bernstein said. "They really don't have the time to do the extra things that would facilitate prescribing the drug."

So the question is are these new limitations on Avandia a good thing or bad thing? It depends on who you ask. Some doctors think the drug should have been banned, but others believe it could be the best available drug to control certain kinds of diabetes.

This appears to be an in-between solution since control of blood sugar is very important. However, the drugs that help control it is just as important.

Dr. Bernstein pointed out that the Metformin drug, which is the most popular diabetes drug in the world now, also once had a lot of opposition in this country.