This information is based on a 10-year study of more than 200,000 patients with type 2 diabetes.
Actos, which was first approved in 1999 to lower blood sugar in people with type 2 diabetes, has now been banned in France and Germany. No such action has been taken as yet in the US.
The FDA ordered Actos manufacturer Takeda Pharmaceuticals to issue a black box warning (the strongest FDA-requested label change) about the serious risk of heart attack, heart failure and cardiovascular-related deaths.
The FDA released a safety alert on Actos about the 40% increased risk of bladder cancer in people taking high doses of Actos or who take it for more than a year. In August 2011, the FDA ordered a label change reflecting this information.
- Bladder Cancer
- Heart Failure
- Macular Edema
- Bone Fractures
- Liver Failure
- Hypoglycemia (when taken with Insulin)
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