First Generic Pioglitazone Approved, With HF Warning


The first generic formulation of the orally administered type 2 diabetes drug pioglitazone has been approved by the Food and Drug Administration, the agency announced on Aug. 17.

Pioglitazone, a thiazolidinedione (TZD), was approved in 1999, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus, and has been marketed as Actos by Takeda Pharmaceuticals America. It is taken once daily without regard to meals.

The generic formulation is manufactured by Mylan Pharmaceuticals. Approved are 15-mg, 30-mg, and 45-mg tablets, the three Actos doses available. As with the brand-name version, patients will receive a Medication Guide with all filled generic pioglitazone prescriptions, which provides information about the drug’s use and safety, according to the FDA statement.

The pioglitazone label has a boxed warning stating that treatment with TZDs, including pioglitazone, can cause or exacerbate heart failure, and that patients on treatment with pioglitazone should be monitored closely for heart failure; it is contraindicated in patients with New York Heart Association (NYHA) III or IV heart failure. The label also includes the statement that the risk of bladder cancer may be increased after 1 year of treatment with pioglitazone, which was added to the drug’s label in 2011. This boxed warning was added to the TZD labels in 2007.

Pioglitazone is also being studied as a treatment for Alzheimer’s disease.

The other TZD on the U.S. market is rosiglitazone (Avandia), but its use is highly restricted because of its associated cardiovascular risks. The Avandia label also includes a statement on the increased risk of myocardial infarction associated with treatment.

Serious adverse events associated with pioglitazone should be reported to FDA’s MedWatch adverse event reporting program at 800-332-1088 or here.

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