FDA Adds Boxed Warning for Heart-related Risks to Avandia, a Drug Used to Treat Diabetes
Should diabetes drugs face tougher standards? With nearly 24 million Americans with Type II Diabetes who are already at risk for heart disease, should we be medicating them with drugs that aggravate or increase the risk for heart disease?
In a Fox News report it was brought to our attention that advisors to the Food Drug Administration (FDA) had voted 14-2 on tougher studies to assure that diabetes drugs don’t increase the risk of heart disease. This comes on the heels of the news release that the FDA will be adding new information on heart disease risk to the existing boxed warning about the potential for increased risk for heart attacks with the use of Avandia, a popular anti-Diabetes drug.
The FDA stated that at this time there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other type 2 diabetes treatments. Therefore, the FDA has requested the Glaxo—Smith Kline (GSK) conduct a new long-term study to evaluate these proposed cardiovascular risks with Avandia. GSK, who currently manufactures Advandia, has agreed to the study with FDA oversight authority.
The boxed warning –FDAs strongest form of warning – includes the following statement:
“A meta-analysis of 42 clinical studies, most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina, or myocardial infarction. Three other studies (mean duration 41 months and 14,067 patients), comparing Avandia to some other product or placebo have not confirmed the risk. The data are inconclusive” FDA advises health providers to closely monitor patients on Avandia.
To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risks. It seems like this should be a top priority agenda item with FDA and the drug manufacturers who are looking at Diabetes treatment. Since the risk for heart disease related deaths are high with Diabetes why treat it with a medication that increases that risk?
Kathy Shattler received her Master of Science degree from Michigan State University in E. Lansing Michigan in Human Nutrition. Her twenty-two years of practice includes holding positions as a Lecturer, Chief Clinical Dietitian and Program Manager. Kathy is the Founder of Nutri-Care Consulting and is currently the Nutrition Director of www.CEU4U.COM, an online continuing education management company for Registered Dietitians and Dietetic Technicians.
