Avandia Heart Failure and Death Risk Higher Than Actos: Study

According to new research, the risk of heart failure or death from side effects of Avandia is higher among older patients than with the competing drug Actos, raising further questions about whether the continued use of Avandia is medically justified.

GlaxoSmithKline PLC’s Avandia (rosiglitazone) and Takeda’s Actos (pioglitazone) are type 2 diabetes drugs, which are both part of the same class of medications known as thiazolidinediones (TZDs).

In August 2007, the FDA added a black box heart failure warning to both drugs, which is the strongest warning that can be placed on a prescription medication. However, a Canadian study published in the August 19 online issue of the British Medical Journal provides further evidence that the risk of heart failure and death among patients 66 years and older is greater for Avandia.

The retrospective cohort study looked at data from 39,736 patients who used Avandia or Actos over a six-year period. For every 93 patients treated with Avandia instead of Actos, researchers found that there would be one additional case of Avandia heart failure, which is a condition where the heart can not pump a sufficient amount of blood to other organs.

“Among older patients with diabetes, pioglitazone is associated with a significantly lower risk of heart failure and death than is rosiglitazone,” researchers said in the study’s conclusion. “Given that rosiglitazone lacks a distinct clinical advantage over pioglitazone, continued use of rosiglitazone may not be justified.”

The conclusion matches concerns expressed by both the American Diabetes Association (ADA) and the consumer advocacy group Public Citizen. In 2008, the ADA recommended against the use of Avandia, and Public Citizen has petitioned the FDA for an Avandia recall.

In addition to the risk of heart failure, other reports have suggested that Avandia side effects may also increase the risk of heart attacks, liver failure, bone fractures, vision loss known as macular edema and death, leading many to conclude that the risks outweigh any potential benefits provided by Avandia.

GlaxoSmithKline PLC currently faces hundreds of lawsuits over Avandia filed by users who allege that the drug maker failed to adequately warn about the health risks associated with the drug. All federal Avandia lawsuits have been consolidated in an MDL, or Multidistrict Litigation, centralized in the Eastern District of Pennsylvania, where the first trial is scheduled to begin early next summer.