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FDA Approves Generic Version of Pioglitazone to Treat Type 2 Diabetes

August 17, 2012

The U.S. Food and Drug Administration (FDA) has approved the first generic version of pioglitazone (sold currently under brand name Actos) for treatment of type 2 diabetes. The drug is used as an adjunct to diet and exercise to control blood glucose levels. The FDA approved 15 mg, 30 mg and 45 mg tablets.
 
"Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes," said Mary Parks, MD, from the FDA's Center for Drug Evaluation and Research.
 
The generic version of pioglitazone will come with the same boxed warning on heart failure as the brand name drug. According to the FDA, thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients. The drug label will also note the increased risk of bladder cancer if taken for more than one year. The drug labels for pioglitazone currently recommend that health care professionals should not use pioglitazone in patients with active bladder cancer and recommend caution in patients with a prior history of bladder cancer.
 
The ACC has a number of resources for providers to help patients manage type 2 diabetes, including:


Stay tuned to CardioSource.org and follow @Cardiology on Twitter for FDA Updates. To receive immediate FDA-approved cardiovascular drug alerts and related safety information, visit www.ACC.pdr.net. Registration is free for ACC members.

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