Editorial Questions Rationale for Not Issuing Avandia Recall

In an editorial released last week on the website for the medical journal Heart, researchers from Wake Forest University School of Medicine question the rationale for not issuing an Avandia recall and indicate that justification for the continued use of diabetes drugs in the same class of medications is “very weak to non-existent.”

The editorial focuses on a class of medications known as thiazolidinediones, which include Avandia (rosiglitazone) and Actos (pioglitazone hydrochloride). These popular drugs are prescribed to help control blood sugar levels among Type-2 diabetics. However, studies have associated the drugs, and particularly Avandia, with an increased risk of congestive heart failure, heart attacks, bone fractures and a vision loss.

Since their approval in 1999, Avandia and Actos have been heavily prescribed to millions of users worldwide on the basis that they help with glycemic control. However, clinical trials have not demonstrated that the drugs reduce the risk of ischemic heart disease or other macrovascular complications secondary to diabetes.

Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences at Wake Forest University School of Medicine, indicate in the editorial that the balance between the benefits of Avandia and Actos and the risk of serious side effects have strongly shifted in an undesired direction.

“We strongly recommend restriction on the use of thiazolidinediones and question the rationale for leaving (Avandia) rosiglitazone on the market,” wrote the researchers in the article published August 29, 2008.

Research has confirmed several serious and potentially life threatening side effects of Avandia and Actos. Thiazolidinediones have been found to double the risk of congestive heart failure and fractures among women. Avandia has been found to cause a 40% increase in the risk of heart attacks, and in rare cases users have experienced macular edema, which could result in vision loss.

Following the publication of a meta-analysis in the New England Journal of Medicine in May 2007, a lot of attention has been focused on the safety of Avandia and whether it should remain on the market.

In July 2007, the FDA convened an advisory panel of outside experts which voted 20 to 3 that the drug increases the risk of heart attacks, but indicated that insufficient evident was available at that time to justify an Avandia recall. Following a heated internal debate, the FDA announced in November 2007 that they would allow Avandia to remain on the market with a stronger black box warning about the potential heart side effects.