FDA Eases Warnings For Avandia

Washington, DCEarlier this week, the US Food and Drug Administration (FDA) announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone). The move is designed to reflect new information regarding the cardiovascular risk of the medicine. The FDA states that their actions are consistent with the recommendations of expert advisory committees.

The safety of Avandia is hugely controversial due to its alleged associated risks for liver failure and fracture. Perhaps most controversial is the risk for Avandia heart attack (MI), together with the potential for Avandia death. Since the drug came to market in 1999, hundreds of Avandia lawsuits have been filed. Eight years after its initial FDA approval, the agency reported seeing a significant increase in the risk of heart attack in those patients to whom Avandia had been prescribed. And many deaths have been linked to Avandia. This, and other factors, such as findings from the landmark study by Dr. Steven Nissen in the New England Journal of Medicine, (2007), resulted in the FDA requiring strengthened safety warnings on Avandia’s prescribing information.

This week, however, the FDA did an about face. “The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, we are requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on our review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI),” the agency said in a statement issued November 25th.

The FDA decision is based on the Avandia review by separate FDA advisory panels gathered to consider the results of the RECORD trial. Meeting in Silver Springs, CO, last June, 20 of the 26 panelists on the FDA’s Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees voted to remove or modify the current restrictions on Avandia.

As an upshot of all this, the FDA has released GSK, the maker of Avandia, from its previous requirement to conduct the TIDE (Thiazolidinedione Intervention with Vitamin D) trial which would have required the comparison of rosiglitazone to pioglitazone and other diabetes meds. The FDA stated that it had concluded that the trial was no longer necessary or feasible.