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European Medicines Agency recommends new contraindications and warnings for pioglitazone-containing medicines

Notice type: Advisory

Date: 21/07/2011

  

Product name or type:
Actos and Glustin (pioglitazone hydrochloride). Competact and Glubrava (pioglitazone hydrochloride and metformin hydrochloride). Tandemact (pioglitazone hydrochloride and glimepiride).

Problem Or Issue:
The European Medicines Agency (EMA) has today published an update on the outcome of its review of pioglitazone-containing medicines and the occurrence of bladder cancer, previously highlighted in June 2011. The EMA’s scientific committee, the Committee for Human Medicinal Products (CHMP), concluded that the evidence from different sources shows that there is a small increased risk of bladder cancer with pioglitazone. However, the benefit-risk balance remains positive in a limited population of type 2 diabetics. The CHMP concluded that the small increased risk could be reduced by appropriate patient selection and exclusion. Use of pioglitazone is now contraindicated in patients with current or a history of bladder cancer and in patients with uninvestigated macroscopic haematuria. 

In addition to other recommendations, the CHMP advised that risk factors for bladder cancer should be assessed before initiating treatment and patients should be reviewed after three to six months (and regularly thereafter) to assess adequacy of response to treatment. 

The product information for these medicines will be updated to reflect these new recommendations.

Background Information Or Related Documents:
European Medicines Agency recommends new contraindications and warnings for pioglitazone-containing medicines Document

Further Information:
See EMA press release for further information.

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