FDA Reaffirms Bladder Cancer Risk With Use of Pioglitazone

The FDA has released an updated safety announcement following a fresh review of data on the type 2 diabetes (T2D) treatment pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni). Following this recent review, the FDA has reaffirmed that the drug may increase a person’s likelihood of developing bladder cancer.

Original reports of the existence of such a risk were published about 5 years ago in 2011, when a study designed by researchers at Kaiser Permanente examined the association between pioglitazone therapy and risk of bladder cancer among 193,099 patients. The study concluded that long-term (more than 2 years), not short-term use, was the culprit. However, a study published in JAMA more than a year back contradicted these findings to report that pioglitazone use was not associated with any such risk of bladder cancer. However, the study found that additional research was necessary on the drug’s impact on developing pancreatic or prostate cancer.

Following the 2011 report, the FDA updated the drug label for pioglitazone-containing medications. The updated label recommended that healthcare professionals should:

• Not use pioglitazone in patients with active bladder cancer.
• Use pioglitazone with caution in patients with a prior history of bladder cancer.

The label also recommended that patients should contact their healthcare professional if they experience:

• Blood or a red color in the urine
• New or worsening urge to urinate
• Pain when urinating

Subsequently, the FDA directed the drug manufacturer, Takeda Pharmaceuticals, to continue a 10-year follow-up study with the drug.

A more recent study in BMJ, which followed patients in the United Kingdom for an average period of 4.7 years, has confirmed the original findings. Of the 145,806 patients included in the study who were newly treated with antidiabetic drugs, 622 developed bladder cancer—compared with rosiglitazone, pioglitazone significantly increased the risk of developing bladder cancer in these patients.

Taking all these studies into consideration, the FDA believes that pioglitazone use may be linked to an increased risk of bladder cancer. “We urge patients and healthcare professionals to report side effects involving pioglitazone or other medicines to the FDA MedWatch program,” the FDA announcement stated. This can be via telephone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by visiting https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.