THURSDAY, June 16 (HealthDay News) -- The U.S. Food and Drug Administration is warning consumers that the popular diabetes drug Actos (pioglitazone) may increase the risk of bladder cancer when used for more than a year.
The agency's warning comes five days after Germany and France pulled Actos from the market, citing similar concerns. Actos is in a class of drugs called thiazolidinediones, the only other member of which, Avandia (rosiglitazone), was taken off U.S. pharmacy shelves in May because it was linked to an increased risk of heart attacks.
The new cancer warning will appear on the labeling, the FDA said.
However, although Actos does have some side effects, "the beneficial effects of Actos, I think, outweigh any possible risk of cancer," said Dr. Joseph Giangola, medical director of diabetes at Hackensack University Medical Center in Hackensack, N.J.
Actos is used to control blood sugar and is sold alone or in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). In 2010, more than 2 million patients were taking these drugs, according to the FDA.
The new warning is based on FDA's review of data from an ongoing study, which found that Actos increased the risk of bladder cancer among patients taking the drug over a long period at the highest doses.
In one study involving more than 193,000 patients with diabetes, patients taking Actos were on the drug for an average of two years, the FDA said. "Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40 percent increase in risk [for bladder cancer]," the agency said.
In addition, the agency says it is aware of the French study that caused France to pull the drug. That study showed a dose-response effect, where risks for bladder cancer rose as time spent taking Actos lengthened past one year.
All rights reserved