FDA Issues Warning about Actos after Medication Pulled in France, Germany

Less than one week after Actos was pulled from the market in France and Germany, the U.S. Food and Drug Administration has issued a warning to patients that prolonged use of the diabetes drug could increase the risk of bladder cancer.

According to HealthDay, Actos, which is in the class of drugs called thiazolidinediones, is similar to Avandia, which will be taken off U.S. pharmacy shelves in November after research linked it to increased risks of heart attacks.

For Actos, the FDA said that the new warning about potential bladder cancer risks will be added to the drug's label, according to the news source.

The drug, which is used to help control blood sugar either by itself or in combination with another medication, was used by more than 2 million patients last year, the FDA said.

The new warning, however, is a result of an ongoing study suggesting that the risk of bladder cancer rises in patients using the drug for more than a year at its highest doses, according to the news source. One specific study examined 193,000 diabetic patients who had taken Actos (pioglitazone) over an average of two years.

"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 FDA noted.

The FDA also indicated that it had been made aware of the French study that ultimately led to the drug being pulled from the market in the European country. In that study, researchers found that the risk for bladder cancer increased as patients began taking the drug for more than one year.

According to the National Center for Biotechnology Information, other side effects of Actos can potentially include mood changes, nervousness and dizziness.