The U.S. Food and Drug Administration has announced that the controversial diabetes drug Avandia is being pulled from the market because of the cardiovascular risks it poses to patients. The drug will no longer be sold at retail pharmacies beginning in November. According to the new rules, which will go into effect on November 18th, the medication will only be available to patients who have been safely using the drug, those who have had no success in controlling their blood sugar with other diabetes medications or patients who have been informed of the risks and still choose to take Avandia (rosiglitazone). These patients must be enrolled in a special program to qualify to receive the drug, according to the FDA. In a statement released on May 18th, the FDA said:
Under the Avandia-Rosiglitazone Medicines Access Program, rosiglitazone medicines will only be available to enrolled patients by mail order from certified pharmacies participating in the program. The drug manufacturer, GlaxoSmithKline, will withdraw rosiglitazone medicines from the current supply chain and will provide pharmacies with instructions on returning the medicines.
Rosiglitazone is also sold under the names Avandamet (where the drug is combined with metformin) and Avandaryl (rosiglitazone plus glimeperide). The new rules apply to those combination drugs as well. The withdrawal of Avandia and related products from drugstore shelves comes eight months after the FDA severely restricted use of rosiglitazone to those patients with type 2 diabetes for whom other medications do not work. Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, in an interview with USA Today, had this to say:
It’s like a decade-long nightmare coming to an end. Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it.
Dr. Nissen has long urged that Avandia be pulled from the market. He led a study, published in 2007, that found that people with type 2 diabetes who took the drug had a 40 percent increase in heart attack risk. That increase in risk was supported in subsequent trials. More than 23 million Americans are thought to have type 2 diabetes. According to the FDA, almost a half-million Americans filled a prescription for rosiglitazone in the first ten months of 2010. Recently, that number has been on the decline. As part of restrictions put in place by the FDA back in September, doctors now have had to state and document a patient’s eligibility to use Avandia. The doctors also have to tell patients about the cardiovascular safety risks associated with Avandia. It’s significant that patients have to acknowledge that they understand those risks.
In Europe, the European Medicines Agency suspended marketing of the drug last year, forcing patients to find other medications to control their blood sugar levels. Rosiglitazone belongs to a class of drugs known as thiazolidinediones. It’s intended to be used along with diet and exercise to control blood sugar levels in patients with type 2 diabetes. The latest FDA action does not affect the other major thiazolidinedione, Actos (pioglitazone), made by Takeda Pharmaceuticals. According to the FDA, that drug has not shown the heart risks seen in the Avandia trials.
Sources: USA Today and health.usnews.com
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.