written by Michael O’Leary
Less than a week after France and Germany banned the use of pioglitazone, the FDA approved a generic version of the drug Actos for adults with type 2 diabetes.
As reported by Medpage Today, generic drug manufacturer Mylan Pharmaceticals was given approval for three dose levels of the drug, 15 mg, 30 mg and 45 mg. The approval comes just a year after the FDA approved updated labeling warning of bladder cancer risk for drug combinations using pioglitazone. The generic version will include the same warnings about heart failure and increased bladder cancer risk as the brand name versions.
(published site)

Dr. Gregory Geba, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research indicated that the agency finds that the benefits outweigh the risks.
“Controlling blood sugar levels is very important in preventing or reducing the long-term health complications of diabetes,” Geba said in the FDA’s press release. “Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition.”
Pioglitazone is used with a diet and exercise and sometimes with other drugs, to treat type 2 diabetes. It works by increasing the body’s sensitivity to insulin, a natural substance that helps control blood sugar levels.
The package labeling warns that pioglitazone may cause or worsen heart failure, which is a condition in which the heart is unable to pump a sufficient volume of blood for the body’s needs. It also warns that using the drug for more than one year may be linked to a higher risk of bladder cancer. The FDA recommends doctors carefully monitor patients when starting the drug or increasing the dosage.
The FDA label also lists the most common side effects may include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat. Information about the availability of generic pioglitazone can be obtained from the manufacturer.
Pioglitazone belongs a class of drugs, called thiazolidinedione, or glitazones. AVANDIA, another glitazone, was severely restricted by the FDA two years ago. Medpage Today earlier reported that there have been suggestions that the bladder and heart effects may be common to all drugs of this class; more studies will be required, however, to determine that. In addition to the FDA, the European Medicines Agency and their Japanese counterpart have withheld further updates to the drug labeling pending additional reviews of the data.