FDA meets over potential heart risks with Diabetes drugPosted: Updated:
Two Food and Drug Administration advisory committees are meeting to discuss potential heart risks associated with the diabetes drug, Avandia, compared with similar drugs.
The FDA has pointed to studies that claim to show an increased risk for heart attack in patients who take the drug.
Monday, an FDA scientist said the drug should be pulled from the market because its potential risks don't appear to outweigh its benefits.
In response, drugmaker Glaxo-Smith-Kline is presenting what it calls extensive data disputing those claims.
In a release, Monday, G-S-K officials say their data show no increase in cardiovascular death or difference in heart attack risk compared with similar drugs.
An estimated 1 million American with type two diabetes take Avandia to control their blood sugar.
-The drug is also called Rosiglitazone
-Release from GSK "New information being presented by GSK that examined a database of over 400,000 diabetic patients enrolled in 80 U.S. health plans. the study compared hospitalizations for heart attacks and procedures to reopen blocked arteries (or cardiac revascularizations). The study showed that there was no increased risk of heart attack or coronary revascularizations among patients taking Avandia compared to Actos, and/or the two most comonly prescribed oral diabetes treatments, Metformin and Sulfonylureas.