The US Food and Drug Administration issued a safety alert for Avandia, a widely prescribed drug to treat type-2 diabetics. According to FDA, Studies show that there is “a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.” By “potentially significant” they are referring to the 30% – 40% increased risk as suggested by data provided to FDA by GlaxoSmithKline, the manufacturers of Avandia.
However, there are also studies that provide contradictory evidence about any link between heart attacks and Avandia in patients treated with the drug for type-2 diabetes. Furthermore, FDA warns that there are risks in switching patients from one diabetes treatment to another. Therefore, patients who are taking Avandia should speak to their doctor before ceasing their treatment.
Diabetics who have underlying heart disease, or who are at high risk for heart attacks should immediately speak to their physician about Avandia and the possible increase in heart attacks and the risks of heart-related death.
Avandia was approved in 1999 for treatment of type 2 diabetes, which affects about 20-million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since Avandia was approved, FDA has been monitoring several heart-related side effects, including congestive heart failure. FDA has updated the product’s labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also includes a new warning about a potential increase in heart attacks and heart-related chest pain in some patients using Avandia. This new warning was based on the result of a controlled clinical trial in patients with EXISTING congestive heart failure.
However, Avandia’s manufacturer (GlaxoSmithKline) recently provided FDA with an analysis of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term treatment with Avanda may have a 30-percent to 40-percent greater risk of heart attack and other heart-related side effects than patients treated with a placebo or another anti-diabetic therapy. This is a significant concern because patients with diabetes are already at an increased risk of heart disease.