In its July meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency finalised the benefit-risk assessment for medicinal products containing pioglitazone. This confirms a slightly increased occurrence of bladder cancer due to pioglitazone. As a risk-minimising measure it recommends that physicians should only administer pioglitazone to patients if it is proven that they will benefit from this therapy. This decision should consider the risk profile of the patients in terms of the occurrence of bladder cancer.

risk information - full text (available in German only)

Pressemitteilung der EMA vom 21.07.2011 (European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer)