The US Food and Drug Administration announced Friday it has begun a safety review of the diabetes drug Actos after preliminary results of an ongoing study showed the medication might increase the risk of bladder cancer in some patients.
Actos, also known as pioglitazone, is made by Takeda Pharmaceuticals. It has been in the news lately as the safer alternative to GlaxoSmithKline’s Avandia, or rosiglitazone, which has been linked to increased risk of heart failure, heart attacks and strokes.
The FDA announced the review after getting five-years of data from a 10-year observational study of Actos by Takeda. The results showed no overall increased risk of bladder cancer.
“However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug,” the FDA stated. “Patients should talk to their health care professional if they have concerns about Actos. They should not stop taking the drug unless told to do so by their health care professional.”