The European Medicines Agency (EMA) has announced (PDF) that it is conducting a safety review of pioglitazone containing medicines. The Food and Drugs Administration (FDA) is conducting a similar review.
This review is being conducted as a result of a recently completed French study which found an increased risk of bladder cancer. The French authorities have suspended the product license as a result of this finding pending a full review.
The results of the review are expected to be available in July. The EMA also state that the association between bladder cancer and pioglitazone use has been under continuous review since the product license was granted in 2000. Three previous reviews have failed to confirm a clear association but have indicated a potential increased risk in those with longest exposure and highest cumulative dose.
Action: Clinicians should be aware of this review. It would be prudent to avoid initiating new treatment with pioglitazone until the review is completed. Patients currently taking pioglitazone who are concerned about the potential increase in risk could be reviewed and have their treatment changed if this will maintain patient-clinician trust.