Avandia Spotlight, Would You Use This Drug?
The antidiabetes drug Avandia (rosiglitazone) is under scrutiny right now as its maker, GlaxoSmithKline, hopes the the Food and Drug Administration (FDA) will lift or loosen the restrictions placed on it. Given the history of Avandia, would you use this drug to treat your type 2 diabetes?
What does Avandia have to offer?
When you go for a job interview, some of the information you present a potential employer are your job history, performance, and qualifications. Avandia, which originally entered the market in 1999, had some performance problems in the past, which caused it to be placed on probation (under severe restrictions) by the FDA in 2011.
According to those limitations, the drug can be dispensed via mail order to individuals only after they signed an informed consent form and registered, and then the drug is available only from specially certified pharmacies. Why? Because studies indicated Avandia could increase the risk of heart attack and death related to cardiovascular causes.
Another negative mark against Avandia is the fact that the European Medicines Agency suspended use of rosiglitazone in 2010, before restrictions were placed in the United States. Indeed, evidence of concerns about cardiovascular risks associated with Avandia was published several years earlier, in 2007.
In the September 2007 issue of the Journal of the American Medical Association, researchers reported on the findings of a meta-analysis concerning long-term risk of cardiovascular events with use of Avandia. Evaluation of data from the four selected trials, which involved 14,291 patients with type 2 diabetes, revealed Avandia (taken for at least 12 months) significantly increased the risk of heart attack and heart failure, but without a significant increase in the risk of dying of cardiovascular events.
But not all studies came to the same conclusion. In 2012, investigators from the University of Georgia reported their findings after conducting an extensive literature search. They reported that it was inconclusive as to whether Avandia use could lead to an increase in cardiovascular events.
In fact, the authors pointed out that the only prospective randomized trial designed to determine cardiovascular outcomes using Avandia (RECORD: Rosiglitazone Evaluated for Cardiovacular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes) had problems with the study design. They therefore concluded that “data involving rosiglitazone and an association with ischemic cardiovascular risk have yielded variable results.”
What will be Avandia’s fate?
For now, seven of the 26 FDA advisers (the FDA’s Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees) voted to remove all limitations on Avandia use, while 13 voted to loosen or modify the restrictions, five voted to leave them the way they are, and one wanted Avandia banned. The FDA can either go along with the panel’s recommendations or not, although the odds are in favor of the drug based on the FDA's past performance.
In addition to the possibility of cardiovascular events, common side effects of Avandia include headache and cough. Less common but serious side effects may include bone fractures, menstrual cycle changes, rapid heartbeat, jaundice, persistent nausea/vomiting, dark urine, vision problems, and abdominal pain.
If you have type 2 diabetes and the restrictions currently on Avandia are loosened, would you consider taking the drug? Naturally, that’s a decision you should make along with your healthcare provider while considering the numerous other treatment options, both pharmaceutical and lifestyle, that are available.
Bourg CA, Phillips BB. Rosiglitazone, myocardial ischemic risk, and recent regulatory actions. Annals of Pharmacotherapy 2012 Feb; 46(2): 282-89
Singh S et al. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. JAMA 2007 Sep 12; 298(10): 1189-95