FDA action related to medication safety and reliability, September 2007

Briefs of FDA actions related to medication safety and reliability

Key Points

FDA has requested that a boxed warning regarding an increased risk of heart failure be added to the product labeling for all drugs in the thiazolidinedione class. The manufacturer of rosiglitazone, rosiglitazone/glimepiride, and rosiglitazone/metformin (Avandia, Avandaryl, and Avandamet, respectively; GlaxoSmithKline) and the manufacturer of pioglitazone and pioglitazone/glimepride (Actos and Duetact, respectively; Takeda) have agreed to add the warning, which states that the drugs, which are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 diabetes, may cause or worsen heart failure in certain patients. In the warning, healthcare professionals are advised to observe patients carefully for the signs and symptoms of heart failure once drug therapy has been initiated. The warning also states that these agents should not be used in patients with serious or severe heart failure who have significant limits on their activity and who are comfortable only at rest or are confined to a bed or chair.