The FDA ( Food and Drug Administration ) has informed the public that the Agency has approved updated drug labels for the Pioglitazone-containing medicines to include safety information that the 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 five-year interim analysis of an ongoing, ten-year epidemiological study. The five-year results showed that although there was no overall increased risk of bladder cancer with Pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to Pioglitazone, and in those exposed to the highest cumulative dose of Pioglitazone.

FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with Pioglitazone. 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.

FDA recommends that healthcare professionals should:

a) not use Pioglitazone in patients with active bladder cancer;

b) 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.

Pioglitazone-containing medicines: Actos ( Pioglitazone ), Actoplus Met ( Pioglitazone and Metformin ), Actoplus Met XR ( Pioglitazone and Metformin extended-release ), Duetact ( Pioglitazone and Glimepiride ).

Source: FDA, 2011

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