Diabetes medicine pioglitazone linked to bladder cancer
19 July 2011
The Therapeutic Goods Administration (TGA) has warned about the safety of the diabetes medicine pioglitazone following research linking long-term use to an increased risk of bladder cancer.
Pioglitazone (e.g. Actos) is an oral tablet that may be prescribed for patients with type 2 diabetes to help control their blood sugar levels.
A US study found patients with type 2 diabetes taking the medicine for more than 24 months had 1.4 times the cancer risk of patients not taking it.
A preliminary assessment of data from a French trial also showed an increased risk of bladder cancer in patients taking the drug for more than 12 months, according to the TGA, the regulatory authority for medicines in Australia (TGA safety advisory, online 18 Jul 2011).
"The TGA is advising health professionals and consumers that use of the diabetes medicine, pioglitazone, for more than a year may be associated with an increased risk of bladder cancer," the regulator said.
Health professionals should not prescribe pioglitazone for patients with bladder cancer or a history of it, and anyone taking the drug should be informed of the risk and alert to the cancer's symptoms, it said.
"The TGA is undertaking a comprehensive review of the data from the French trial and will provide further information to health professionals and consumers once this has been completed," the TGA said.
Regulators in Europe and the US had issued updated safety advisories, while France, Germany and Mauritius had suspended use of the drug.
More than 474,000 prescriptions for pioglitazone were filled in the 12 months to May in Australia.
A spokesperson for Eli Lilly, manufacturer of Actos, said the product information had been updated to note the risk of bladder cancer.
"Eli Lilly and Company will continue to carefully monitor adverse events through ongoing surveillance and analysis, in addition to ongoing epidemiologic investigations," the spokesperson said.
Healthcare professionals should report any adverse reactions suspected to be associated with the use of pioglitazone to Eli Lilly Australia Global Product Safety or to the TGA.
Last Reviewed: 19 July 2011
- 1. Therapeutic Goods Administration. Pioglitazone and risk of bladder cancer: safety advisory (last updated 18 July 2011). http://www.tga.gov.au/safety/alerts-medicine-pioglitazone-110718.htm (accessed Jul 2011).
