FDA Warns of Actos Bladder Cancer Risk

FDA Warns of Actos Bladder Cancer RiskAfter nations in the European Union performed several studies on Takeda Pharmaceutical's diabetes drug Actos, leading to suspension of the medicine in France and Germany, the U.S. Food and Drug Administration came out saying the popular drug may increase the risk of bladder cancer if used for more than a year, HealthDay reported.

According to the news source, Actos belongs to a class of medicines called thiazolidinediones, the same class in which Avandia is found. Avandia was removed from pharmacy shelves in America, after it was linked to an increased risk of heart attack in May of 2011.

The FDA has ordered that the new cancer warning must appear on the labeling of Actos.

Actos is used as a means to control blood sugar in diabetics and is often used in combination with metformin and glimepiride. It has been a very popular choice for doctors to prescribe, as more than 2 million patients were taking Actos in 2010.

The FDA decided to create the new label for the drug after reviewing data from an ongoing study that found patients who took Actos for long periods at high doses had an increased risk of bladder cancer, HealthDay stated.

Another study involved more than 193,000 diabetic patients who had been taking Actos for two years on average.

"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 response to the large study.

The FDA also acknowledged the French study that prompted health officials in the country to pull Actos from the shelves, stating that the study accurately outlined a dose-response effect in which bladder cancer risks rose after patients had taken the drug for more than one year, according to HealthDay.

Now, the FDA is urging doctors to steer away from prescribing Actos to patients who already have bladder cancer and to use caution when prescribing to patients who have had bladder cancer in the past. The agency warns that diabetic patients should seriously weigh the "benefits of blood sugar control with pioglitazone against the unknown risks for cancer recurrence."

The FDA says that those who take diabetes medicines such as Actos should report any symptoms of bladder cancer, which include blood in the urine, abdominal pain, incontinence and weight loss, according to the National Library of Medicine.