The Food and Drug Administration said it is adding this information to the label for the drug after reviewing the preliminary five-year results of an ongoing 10-year study.
The announcement comes after France as well as Germany stopped the sale of of Actos last week.
From the FDA site:
The FDA recommends that healthcare professionals should:
- Not use pioglitazone in patients with active bladder cancer.
- Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.
In 2010, the FDA posted this information on its website:
FDA NOTE TO CORRESPONDENTSFor Immediate Release: Sept. 17, 2010
Media Inquiries: Karen Riley, 301-796-4674; email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA reviewing preliminary safety information on Actos (pioglitazone)The U.S. Food and Drug Administration today announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.
The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. These early results showed no overall association between Actos exposure and 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.
At this time, the FDA’s review is ongoing. The agency has not concluded that Actos increases the risk of bladder cancer.
Actos is used to control blood sugar in patients with type 2 diabetes mellitus. It is in the class of drugs known as peroxisome proliferator-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.
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.