New U.S. Food and Drug Administration (FDA) regulations imposed upon the controversial diabetes drug Avandia will prohibit local retail pharmacies to carry the medication due to a confirmed risk for heart attack and other cardiovascular complications.
This motion applies to three anti-diabetes drugs manufactured by GlaxoSmithKline, Avandia, Avandamet and Avandaryl, that contain rosiglitazone - a drug that increases sensitivity to insulin and removes extra glucose from blood.
Avandia is a type II diabetes controller drug that first hit the market in 1999. It was designed to help type II diabetes patients increase their insulin levels by increasing the sensitivity of insulin receptors. For several years, Avandia generated billions of dollars annually for its Manufacturer, GlaxoSmithKline.
By 2007, many reports of serious and sometimes fatal side effects had already begun to surface. After a study was published showing that Avandia raises its users' risk of heart attack by 43% and their risk of death from heart problems by 64%; the FDA issued a Black Box warning, the FDA's most significant action short of a recall.
Emerging evidence shows that the FDA may have known about Avandia's cardiac risks long before the 2007 study.
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