May 18, 2011
The Food and Drug Administration (FDA) has placed restrictions on medications containing the diabetes drug Rosiglitazone, trade name Avandia. GlaxoSmithKline (GSK), the drugs manufacturer, will be required to create a restricted access program that will limit the patients who can take the drug. Only patients who are currently benefiting from treatment of the drug and choose to continue use, or patients whose glucose levels cannot be controlled with any other drug will be eligible for a prescription.
The report states that after November 18, 2011, patients will no longer be able to receive Rosiglitazone medications from retail pharmacies. Eligible patients will be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to receive the medications by mail through a limited number of certified pharmacies.
A study in the Journal of the American Medical Association, found an increased risk of cardiovascular events between patients taking Avandia and a similar drug, Actos. The study found a 25% increased risk of heart failure, a 27% increased risk of stroke, and a 14% increased risk of death.
From January of 2010 to October of 2010, over 460,000 prescriptions were filled for these medications. Although, use dropped by half within that time period from 235,500 patients in January to 119,000 patients in October.
If you or someone you know has been taking a Rosiglitazone-based product such as Avandia, you should contact a North Carolina Medical Malpractice Lawyer. Henson Fuerst Attorneys may be able to assist you with your case.