The FDA notified healthcare professionals that new information is to be added to the Warnings and Precautions section of the label for pioglitazone-containing medications, related to the increased risk of bladder cancer associated with using the diabetes medication Actos (pioglitazone) for more than one year. The medication guide for these medicines will also be revised to include information on the risk of bladder cancer.
This safety information is based on the FDA’s review of data from a 5-year interim analysis of an ongoing, 10-year epidemiological study. The 5-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use; an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative pioglitazone dose.
The FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the study’s results, France has suspended use of pioglitazone and Germany has recommended new patients not be initiated on pioglitazone.
Accordingly, 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.
The FDA will continue to evaluate data from the ongoing 10-year epidemiological study, and it will also conduct a comprehensive review of the results from the French study. The public will be updated when more information is available.
[February 6, 2011] The FDA has notified healthcare professionals and patients that it is reviewing data from a 10-year epidemiological study that aims to evaluate the association between Actos (pioglitaszone), an oral hypoglycemic medicine used in patients with type II (non-insulin dependent) diabetes mellitus, and the increased risk of bladder cancer. While inconclusive, findings from studies carried out on animals and humans suggest that there is a potential safety risk and that further studies are ongoing to ascertain this.
In the meantime, healthcare professionals should continue to follow recommendations in the drug label when prescribing Actos. Patients should also continue taking Actos unless advised differently by their healthcare professional.