Since the Food and Drug Administration (FDA) in June issued a Drug Safety Communication Update for Actos, Sheller, P.C. has continued to investigate the link between Actos and bladder cancer.
The FDC warns that patients using Actos (pioglitazone) for a year or longer have a substantially increased risk of bladder cancer. (Read announcement here).
The FDC update follows on the heels of the FDA’s September 17, 2010, Safety Communication, which revealed that patients taking Actos over several years had an increased risk of bladder cancer. That Safety Communication was based on a planned five-year interim analysis of an ongoing, ten-year study that found as patients’ bladder cancer risks increased with patients’ exposure.
In its latest Communication, the FDA noted a French Study which found a statistically significant increase in the risk of bladder cancer in Actos patients as compared to patients using other diabetic medications. The most significant increase in risk was observed in males.
Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.
If you or someone you know has taken Actos and developed bladder cancer, please call 1-800-833-2299.