The U.S. Food and Drug Administration (FDA) has warned that use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. This safety information is based on FDA’s review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study.
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 this systematic review, Usher-Smith and colleagues looked at 46 studies of more than 24 000 children from 31 countries. They found that multiple factors affect the risk of developing diabetic ketoacidosis at the onset of type 1 diabetes in children and young adults, and there is potential time, scope, and opportunity to intervene between symptom onset and development of diabetic ketoacidosis for both parents and clinicians. In a linked editorial, Sasigarn A Bowden says that the findings from this study should heighten the awareness of clinicians caring for children and adolescents and continuing education should be provided on the presentation of diabetes.” – bmj.com