Avandia Restrictions Removed By FDA Years After Risk Mitigation Program Put in Place

Federal regulators have announced that they are removing a risk mitigation program placed on the diabetes drug Avandia, indicating that the restrictions enacted several years ago over heart attack concerns are no longer necessary. 

In a drug safety communication issued on December 16, the FDA announced it was eliminating the Risk Evaluation and Mitigation Strategy (REMS) for GlaxoSmithKline’s Avandia (rosiglitazone), which has been in place since 2011.

The agency indicates that the “REMS is no longer necessary to ensure that the benefits for rosiglitazone medicines outweigh their risks.”

The Avandia restrictions were first put in place due to potential heart attack side effects, which dropped the drug from a leading diabetes treatment to a “last resort” medication, which has only been used by a few thousand patients in recent years. However, two years later, critics say the agency’s advisors began using data from what they said was a widely discredited study that showed Avandia carried no health risks.

On November 25, 2013, the FDA announced that it was removing some Avandia prescribing and dispensing restrictions; primarily those involving the Avandia REMS Program. However, this latest move is an update, removing all of the remaining restrictions on Avandia.

The decision was anticipated after an FDA advisory committee met over the summer of 2013 to discuss the Avandia restrictions, determining that the agency was wrong to restrict the drug and that data indicates that there may be no significantly increased risk of heart attacks with Avandia. However, the advisory panel has been sharply criticized by many, including the doctor who first raised the alarm bell about Avandia, suggesting that the agency is trying to save face after it failed to initially protect the public from the potential side effects of Avandia.

The move was long predicted by Dr. Steven E. Nissen, who first warned of Avandia heart problems in a 2007 meta-analysis. Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, said earlier this year that the FDA would drop restrictions on the drug to save face, knowing that there was almost no way an Avandia come back was possible at this point.

The FDA initiated a review of the drug without any request from GlaxoSmithKline that the agency do so.

In 2012, GlaxoSmithKline plead guilty to Justice Department charges that it tried to illegally market Avandia and paid fines of about $3 billion. It also paid millions to states for charges that it defrauded their health care programs by failing to provide adequate warning of Avandia heart attacks.

Some reports have suggested that as many as 100,000 heart attacks may have been caused by Avandia, and the drug’s manufacturer has reportedly paid more than $1 billion to settle Avandia heart attack lawsuits brought by former users of the medication who allege inadequate warnings were provided to consumers and the medical community.