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More News On Pioglitazone & Bladder Cancer

Darrell Hulisz, RPh, PharmD

June 27, 2012

In August 2011, the FDA issued a press release that the agency had issued new labeling for pioglitazone-containing medicines. The new labeling was issued to warn that use of pioglitazone (Actos) for more than one year may be associated with an increased risk of bladder cancer. 1 The updated labeling recommends that healthcare professionals should not use pioglitazone in patients with active bladder cancer and should use pioglitazone with caution in patients with a prior history of bladder cancer. Patients were advised to contact their healthcare professional if they experience any sign of blood in the urine or new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.

The advisory and labeling changes were based on a study that had not been fully published until last week. In a recent study in the British Medical Journal, 2 investigators identified 116,000 patients with type 2 diabetes on oral antidiabetic drugs. After a mean follow-up of 4.6 years, 470 patients had received diagnoses of bladder cancer. Pioglitazone use was associated with a significant 83% higher-risk for bladder cancer, relative to non-pioglitazone users. The rate of bladder cancer increased significantly with duration of pioglitazone use, with the highest rates in patients who were exposed for more than 2 years. The results of this study support the FDA advisory from last year. However, it is important to note that the study was not a prospective, randomized trial; it was not designed to prove cause-and-effect between pioglitazone use and bladder cancer. Nonetheless, pharmacists should warn patients of this potential association.

FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines. August 4, 2011. http://www.fda.gov/Drugs/DrugSafety/ucm266555.htm

Azoulay L, Yin H, Filion KB, Assayag J, Majdan A, Pollak MN, Suissa S. The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study. BMJ. 2012 May 30;344:e3645.

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