Pioglitazone has favourable long-term risk benefit profile: TGA

The review, published in the latest Medicines Safety Update, was prompted by research in 2011 linking long-term use of pioglitazone to an increased risk of bladder cancer as well as ongoing safety concerns with another drug in the class, rosiglitazone.

From June 2011 to September 2013, the TGA received 212 adverse event reports involving pioglitazone. Most reports concerned cardiac failure, oedema and weight gain, but there were 11 reports of bladder cancer. 

The TGA found the "potential for bladder cancer increased by 40% (three in 10,000) after two years", with risk appearing to increase with duration of use. 

Other identified risks included a doubling of the fracture risk (from 0.5 to one per 100 patients) for women when compared with non-thiazolidinedione drugs, and an increase in the incidence of heart failure (11% vs 7.5%) and oedema (22% vs 13%) compared with placebo.

In evaluating the benefits, the TGA found