The Food and Drug Administration (FDA) alerting health care professionals that it is reviewing data to determine whether the type 2 diabetes drug Actos (pioglitazone) increases the risk of bladder cancer in patients who use the drug. The data is from an ongoing, 10-year epidemiological study in animals and humans that suggests this is a potential safety risk that needs further study. At this time, the FDA has made no conclusions about the safety of Actos, and the agency will update the public when it has additional information.
Actos, also known by the generic pioglitazone, is a once-daily oral prescription medication that is indicated for the treatment of type 2 diabetes. It is in a class of drugs known as peroxisome proliferators-activated receptor (PPAR) agonists. The only other drug in this class is Avandia (rosiglitazone). The FDA has no clinical information associating Avandia with bladder cancer in patients receiving that drug. Avandia, however, is associated with an increased risk of heart attacks.
Actos manufacturer Takeda conducted a planned analysis of the study data at the five-year mark, and submitted the data to the FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as those exposed to the highest cumulative dose of Actos.
At this time, the FDA’s review is ongoing and the agency has not concluded that Actos increases the risk of bladder cancer. Patients with concerns should talk to their health care professionals, and should not stop taking the medication unless told to do so by their health care professional.
Any adverse events with this or any drug should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.
ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
AVANDIA is a registered trademark of GlaxoSmithKline.