The use of the diabetes drug pioglitazone for more than 1 year may be associated with an increased risk of bladder cancer, the US Food and Drug Administration (FDA) warned on June 15.
The FDA is advising health care professionals to not use pioglitazone in patients with active bladder cancer and to prescribe the drug with caution for patients with a prior history of bladder cancer, weighing the benefits of blood glucose control “against the unknown risks for cancer recurrence” (http://tinyurl.com/3owghao).
The FDA also advised health professionals to counsel patients to report any signs or symptoms that may be due to bladder cancer (such as blood in the urine, urinary urgency, pain during urination, or back or abdominal pain) and to encourage patients to read the medication guide that accompanies the drug.
The warning is based on the FDA's review of data from an ongoing, 10-year epidemiological study. Results based on 5 years of data showed that although pioglitazone use was not associated with an overall increased risk of bladder cancer, there was an increase in the risk of the malignancy among patients with the longest exposure to pioglitazone and in those exposed to the highest cumulative dose of the drug.
In addition to the ongoing study, another epidemiological study conducted in France suggested that pioglitazone use is associated with a risk of bladder cancer, and that country has suspended the use of pioglitazone based on this study's findings, the FDA said. In addition, Germany has warned that pioglitazone should not be prescribed for patients who have not previously used the drug.
The new information about the risk of bladder cancer will be added to the warnings and precautions section of the label for medications containing pioglitazone. The agency also noted that the patient medication guide for these medicines will be revised to include information on the risk of bladder cancer.
The FDA said that it will continue to evaluate data from the ongoing US study and that it will also conduct a comprehensive review of the results from the French study.
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