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Stronger Warnings on Heart Failure Risk for Avandia and Actos Type Drugs

Update: “FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia. Agency says drug to remain on market, while safety assessment continues”

The US Food and Drug Administration (FDA) is requiring some Type 2 diabetes drugs to change its product label to include a heart failure risk warning. This “boxed” warning emphasizes that the class of thiazolidinedione drugs may cause or worsen heart failure in certain patients. Drugs in this class included Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are currently approved in the US for treating type 2 diabetes in combination with diet and exercise. Postmarketing surveillance of these drugs is required by the FDA as a condition of approving these drugs and making them available on market. Postmarketing reports have shown cases of warning signs of heart failure: significant weight gain and edema (water retention and accumulation in organs). Source: FDA.

Updated: June 30, 2013 — 8:07 am

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