August 17th, 2012

FDA OK’s Generic Actos (pioglitazone)

Published: August 17, 2012

The FDA has approved the first generic version of pioglitazone (Actos) for treatment of type 2 diabetes.

Generic manufacturer Mylan Pharmaceuticals was given approval to make 15, 30, and 45 mg tablets, according to a statement from the FDA.

Generic pioglitazone will come with the same boxed warning on heart failure as the brand name drug. The label will also note the increased risk of bladder cancer if taken for more than 1 year found on the branded drug.

The FDA first warned about bladder cancer risk with pioglitazone last year, after an interim review of an ongoing epidemiological study found patients with the longest exposure and highest dose of the drug were at greater risk.

That announcement came days after France and Germany banned use of the drug.

Two recent studies have also confirmed the increased risk of bladder cancer with pioglitazone. Some studies have also suggested bladder cancer may be a class effect of thiazolidinediones (TZDs), although that relationship is still unclear.

Pioglitazone was the second medication in the TZD class to be associated with serious side effects. Two years ago, the use of rosiglitazone (Avandia) was severely restricted in the U.S. over concerns of an increased risk of heart attack.