FDA recently issued a drug safety communication warning patients and health professionals that use of pioglitazone (Actos—Takeda) for more than 1 year may be associated with an increased risk of bladder cancer. This information will be added to the Warnings and Precautions section of the drug label and to the patient Medication Guide for all drugs containing pioglitazone.
This announcement was based on the agency's review of data from a 5-year interim analysis of an ongoing 10-year epidemiological study of more than 193,000 patients at least 40 years old with diabetes in the Kaiser Permanent Northern California health plan. While there was no significant increase in the overall risk of bladder cancer, FDA reported that the risk increased with increasing dose and duration of pioglitazone. Patients who were on pioglitazone therapy for more than 12 months had a 40% increased risk of bladder cancer compared with patients who had never used the drug.
FDA also cited a retrospective cohort study of approximately 1.5 million patients with diabetes conducted by the French National Health Insurance Plan from 2006 to 2009. In this study, there was a statistically significant increase in the risk of bladder cancer in patients who used pioglitazone compared with patients who used other antidiabetic agents after adjusting for age, sex, and use of other antidiabetic medications. This study also found that risk increased in patients with a cumulative dose of exceeding 28,000 mg or duration of treatment longer than 1 year. France has suspended the use of pioglitazone based on this study, while Germany has recommended that patients not start using the drug.
As a result of these findings, FDA recommended that health professionals avoid using pioglitazone in patients with active bladder cancer and use caution with prescribing the drug in patients with a prior history of bladder cancer. Patients were urged to contact their health care provider immediately if they experience any symptoms of bladder cancer, including blood or red color in urine, urgent need to urinate or pain while urinating, and pain in the lower back or abdomen. Any adverse events involving pioglitazone medications should be reported to FDA's MedWatch. |
