The FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees voted 20 of 26 to recommend removing or modifying rosiglitazone's highly restrictive label and distribution system. Five voted to keep the product's risk evaluation and mitigation strategy (REMS) as it is now.
"I find no substantial evidence or information that rosiglitazone is unsafe," Arthur Moss, MD, cardiology professor at the University of Rochester School of Medicine in New York, said, adding its ability to lower blood sugar without causing hypoglycemia proves it could be of use.
Sanjay Kaul, MD, director of cardiovascular fellowship training at Cedars-Sinai Medical Center in Los Angeles, said there's not enough evidence to support or blame rosiglitazone's safety and therefore physicians should be able to choose it if they desire.
Why is this important so far after the fact?
First of all, it’s important because cardiologists need to have faith in the products that they have in their armamentarium.
Second it’s important to set the record/RECORD straight. After the 2010 media circus, the Congressional carnival, and the endless posturing from the Cleveland metropolitan area – yesterday’s adcomm vindicated both the process and the people at the FDA. In 2010 the pressure was withering. In 2013 there was a degree of redemption.
(As Mark Twain quipped, “The rule is perfect: in all matters of opinion our adversaries are insane.”)
Thirdly, the adcomm discussion and vote is important relative to the FDA’s evolving views on the future development and review of diabetes medicines.
Let me embrace thee, sour adversity, for wise men say it is the wisest course.
-- William Shakespeare