FDA to Pull Diabetes Drug Avandia (Rosiglitazone) From Pharmacy Shelves

The US Food and Drug Administration announced that after November 18, 2011, consumers won’t be able to get the Type 2 diabetes drug Avandia (rosiglitazone) from retail pharmacies anymore. That is when new rules will take effect, with the goal of reducing the risk of heart attacks caused by taking the medication.

According to the new rules, Avandia (rosiglitazone) will only be available to patients already taking the drug, and those who have not had success controlling their blood sugar with other diabetes medication. To qualify to receive the drug, both patients and doctors must be enrolled in a special program called the Avandia-Rosiglitazone Medicines Access Program; the certified pharmacies will be able to deliver the medication by mail to the eligible patients.

Rosiglitazone is also sold under the name Avandamet when combined with metformin, and Avandaryl when combined with glimepiride. The new FDA rules apply to those drugs as well.

The withdrawal of Avandia, Avandamet, and Avandaryl from retail pharmacies comes eight months after the FDA severely restricted the use of rosiglitazone to patients with Type 2 diabetes who cannot control their diabetes on other medications

U.S. News and World report that according to a study published by Nissen in 2007, people with Type 2 diabetes who took rosiglitazone had a 40 percent increase in heart attack risk; the increase in risk was supported by subsequent trials. It is believed that more than 23 million Americans have Type 2 diabetes, and according to the FDA, almost a half-million Americans filled a prescription for rosiglitazone in the first 10 months of 2010.

GlaxoSmithKline officials have admitted that they had known of the drug’s potential heart attack risks since at least 2005, although other documents indicate that they had knowledge about the potential for heart problems as soon as the drug was introduced in 1999. Avandia lawyers are helping patients who have suffered severe cardiac problems as a result of taking rosiglitazone, including heart attacks, to pursue damages. If you took Avandia and suffered severe complications or side effects and would like to learn more about pharmaceutical litigation and your legal rights, call (888) 444-8508.