New FDA Restrictions to Remove Avandia From Majority of US Pharmacies

On May 18, 2011, the United States Food and Drug Administration (FDA) announced that new restrictions on the diabetes drug Avandia would be implemented starting on November 18. These new restrictions will essentially remove Avandia (along with similar drugs such as Avandamet and Avandaryl) from the shelves of the majority of U.S. Pharmacies. Patients who are currently using Avandia without suffering adverse health effects and cannot find a replacement drug to treat their diabetes, along with those physicians who wish to continue prescribing Avandia to their patients, will be permitted to enroll in the Avandia-Rosiglitazone Medicines Access Program. This program will require physicians and pharmacies to become certified Avandia prescribers (which involves completion of a training program and agreeing to register those patients who are being prescribed the drug) and it will also require that patients sign a consent form acknowledging that they understand the risk information that their doctor or healthcare provider has talked about with them, including that these medicines may increase their risk of having a heart attack.

As we reported in our Chicago personal injury blog back in September 2010, GlaxoSmithKline (GSK), the manufacturer of Avandia, faced a deluge of lawsuits that were filed on behalf of thousands of patients who suffered various heart complications while taking the drug, including fatal heart attacks. While GSK reportedly agreed to pay $460 million to resolve 10,000 Avandia lawsuits back in 2010, recently, it has been reported that the pharmaceutical manufacturer has set aside over three billion dollars to cover legal costs associated with Avandia-related investigations and lawsuits. While over half a million Americans filled prescriptions for Avandia and Avandia-related drugs during 2010, it is expected that this volume of prescriptions will taper off considerably as these new FDA restrictions are implemented later this year. If you are taking Avandia or similar drugs like Avandamet and Avandaryl, it is important that you speak with your physician about these recent developments and whether or not you should continue using Avandia.

If you or a loved one have suffered a heart attack or experienced heart-related complications while taking these drugs, you may be entitled to compensation for your injuries. To consult with an Avandia attorney in Illinois, call GWC Injury Lawyers for a free consultation. Call 1-312-464-1234 or fill out our “Free Case Evaluation” form.