COMMENTARY

What if Avandia Is Safe After All?

Matthew L. Mintz, MD

Disclosures

May 31, 2013

In This Article

Was the FDA Wrong About Avandia?

Editor's Note: The author has disclosed a financial relationship with GlaxoSmithKline (GSK), the manufacturer of Avandia®, which is discussed in this article.

After severely restricting the use of the diabetes drug rosiglitazone (Avandia) in 2010, the US Food and Drug Administration (FDA) recently announced that it will convene a panel in early June to review a reanalysis of safety data on rosiglitazone. The FDA's earlier action was prompted by concerns about excess cardiac risk associated with the drug, and many experts have been predicting that the new review would be the final "nail in the coffin" for rosiglitazone, leading to its complete withdrawal from the market.

However, there is good reason to believe that the opposite may be true. And if the FDA got it wrong on Avandia, the implications would be far-reaching:

Although some patients taking Avandia switched to Actos® (pioglitazone, another drug in the same class of thiazolidinediones [TZDs]), many simply discontinued their diabetes medications altogether and were unnecessarily harmed.

Avandia is the only diabetes drug to show sustained glycemic control over several years (although this is probably a class effect and applicable to Actos as well). Many patients on older drugs, such as metformin and sulfonylureas, eventually lose control of their glucose levels (most after 3 years[1]) and require additional medications and eventually insulin. This does not appear to be the case with Avandia, which has shown sustained glycemic control for 4-5 years.[2] When the FDA restricted Avandia -- scaring some patients and doctors away from Actos as well -- this escalation to insulin probably occurred more rapidly and in more patients. Although insulin is an important drug in the treatment of diabetes, it carries a risk for hypoglycemia and requires that patients inject themselves and check their glucose levels frequently.

GSK (the maker of Avandia) underwent a federal investigation into whether it properly reported potential safety concerns, leading to a $3 billion settlement. Although some may not care if a profitable drug company had to pay an unfair fine, one could argue that the money could have been used to develop new medications or to avoid price hikes for existing drugs.

The FDA action on Avandia essentially changed the approval process for all new diabetes drugs, requiring manufacturers to run lengthy and expensive trials to "prove" that their drug does not cause heart attacks. This delayed arrival of several new diabetes medications, such as alogliptin and dapagliflozin, as well as new obesity medications. If Avandia is actually safe, many useful therapies could have been available much sooner.

If you search the Internet for "Avandia," you probably will retrieve advertisements from lawyers seeking participants for a class action suit. The proliferation of these "bad drug" ads has fueled patient fears of practically all medications. Although some degree of caution is warranted with any new medication, this heighted fear caused by the FDA's action on Avandia may have been avoided if the drug is now found to be safe.

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