FDA OKs Generic Actos for Type 2 Diabetes
Aug. 17, 2012 — The FDA today approved the first generic version of Actos to treat adults with type 2 diabetes.
The generic tablets use the same active ingredient as Actos, called pioglitazone, to improve blood glucose control in adults with type 2 diabetes.
“Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition,” Gregory Geba, MD, director of the FDA’s Office of Generic Drugs, says in a news release.
According to the CDC, about 26 million Americans have diabetes, or 8.3% of the population. Diabetes and its complications are among the leading causes of death in the U.S.
Pioglitazone carries a warning about the risk that it may cause or worsen heart failure, and that using pioglitazone for more than one year may be linked to a higher risk of bladder cancer. The FDA recommends careful monitoring of patients when starting the drug or increasing the dosage.
The most common side effects of pioglitazone include sinus infection, muscle pain, headache, and sore throat.
The generic version of pioglitazone is made by Mylan Pharmaceuticals. The FDA states that the generic drugs it approves “are of the same strength and quality” as their brand-name counterparts.