FDA Panelists Vote to Ease Restrictions on Avandia
Avandia, also known as rosiglitazone, may get a second chance after a panel of FDA advisers voted 20 to 26 to remove or modifying the drug’s highly-restrictive label and distribution system.
Specifically, 13 panelists voted to modify and seven to remove the Risk Evaluation and Mitigation Strategy (REMS) program in place, while five voted to continue and one voted to have it withdrawn from the U.S. market.
Once a multibillion-dollar blockbuster, according to Triangle Business Journal, Avandia lost its spot as a leader in treating type 2 diabetes after a study began to circulate tying it to an increase in heart attacks.
The vote comes just as researchers at the Duke Clinical Research Institute issued a report stating that, based on a re-analysis of the drug, researchers did not discover any link between the drug and an increase in heart attacks.
Required by the FDA, the study was funded by the drug’s manufacturer GlaxoSmithKline.
In response to the vote, the company’s Chief Medical Officer Dr. James Shannon pointed to a continued relationship with the U.S. agency in a statement, thanking the panel for their “thorough examination” of the situation.
Shannon further took the opportunity to once again assert his belief in the safety of the drug.
“We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling.”
Dr. Arthur Moss is a cardiology professor at the University of Rochester School of Medicine. In an interview with MedPage Today, Moss said he wasn’t convinced of the drug’s link to increased heart attacks, stating "I find no substantial evidence or information that rosiglitazone is unsafe.”
On the other hand, Ida Spruill was one panelist to ban Avandia and, as a person with diabetes, once took Avandia, according to Menical News Today.
As a nurse, Spruill explained her decision by saying that she would not be comfortable prescribing the drug to her family members or other patients.