Restrictions Announced in Avandia Use

Seattle, WAEight months after the US Food and Drug Administration (FDA) announced that restrictions would be imposed on Avandia use, the federal government has announced how those restrictions will look. Limitations on the use of Avandia were announced after concerns about Avandia side effects were raised. Those Avandia risks included a reported increased risk in heart attack. Now, concerns are also being raised about risks associated with rival drug Actos, according to J. Benton Stewart II, attorney at Stewart Law, P.L.L.C.

According to USA Today (05/18/11), among the government's announcements were that Avandia will be pulled from retail pharmacies in November 2011 and that only doctors who are certified will be allowed to prescribe Avandia. Furthermore, patients must be informed about the risks and can only fill their prescriptions by mail order and through certain pharmacies. Only patients who are currently on Avandia or whose diabetes cannot be controlled with other medications, or who do not want to use medications containing pioglitazone (including Actos) will be allowed to use Avandia.

The restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS), which is implemented to ensure the safety of patients who use a medication. The FDA (05/18/11) noted the reported elevated risk of heart attacks in patients taking Avandia in making its announcement.

"For several years, there have been concerns about the potential for a cardiovascular ischemic risk associated with rosiglitazone," FDA noted (09/23/10). "Cardiovascular ischemia is a deficiency of blood flow to tissue usually due to constriction or an obstruction of a blood vessel. These concerns have arisen from multiple data sources, including various meta-analyses and observational studies."

In 2007, Dr. Seven Nissen raised concerns about Avandia (known generically as rosiglitazone) and the risk of heart attacks. His study suggested that use of Avandia increased the risk of heart attack by up to 40 percent in patients who had type 2 diabetes.

Following release of this information, some patients were switched to Actos, according to Stewart. "Many people who began taking Avandia were switched to Actos as a less expensive drug," Stewart says. "At the time, it was believed that Actos was not as harmful a drug, but over time that has not been proven to be true. The FDA has linked Actos to bladder cancer, which is now a warning on the Actos label.

"Patients who took Avandia before Actos or who were turned down in the Avandia litigation because they also took Actos may be eligible to file a claim against the makers of Actos."