On June 15, 2011, the U.S. Food and Drug Administration (FDA) released a ‘Drug Safety Communication,’ informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.
The FDA is recommending that healthcare professionals not use pioglitazone in patients with active bladder cancer and are urged to 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, the FDA added.
In a five-year interim analysis of the Kaiser Permanente Northern California, (KPNC) study, the FDA found that there was no significant increase in the risk for bladder cancer in patients taking pioglitazone. However, it was found that the risk for bladder cancer did grow with increasing dose and use longer than one year. The data showed that pioglitazone treatment for over 12 months carried a 40% increased risk of bladder cancer.
The French Medicines Agency suspended the use of pioglitazone-containing medicines on June 10, 2011. The decision by the French authorities was based on the results of a French retrospective cohort study, which became available on June 9, 2011. The German Federal Institute for Drugs and Medical Devices followed suit and advised physicians to stop prescribing the type 2 diabetes drug pioglitazone (Actos) to their patients based upon the French data.
The study, conducted by the French Health Insurance Agency, examined cancer rates in some 155,000 diabetics taking pioglitazone in France from 2006 to 2009 and 1.3 million other patients who were not receiving the agent. The researchers found an adjusted hazard ratio of 1.22 (95% CI 1.05 to 1.43) for bladder cancer among those on pioglitazone. There also appeared to be a dose effect, with a higher risk (HR 1.75, 95% CI 1.22 to 2.50)
FDA said it will continue to evaluate data from the ongoing ten-year epidemiological study and will conduct a comprehensive review of the results from the French study. The FDA will update the public when more information becomes available.
Roger Drake at Baum Hedlund Aristei Goldman has begun an investigation into the drug causing bladder cancer; “Patients diagnosed with bladder cancer face a difficult battle and require a long course of treatment,” said Drake. “If Actos caused bladder cancer, the drug company should not deny compensation for the harms and losses caused by their drug.”
Actos (pioglitazone) is a diabetes medication that was approved on July 15, 1999 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus. Actos is manufactured by the Japanese drug company Takeda Pharmaceuticals. Its U.S. subsidiary, Takeda Pharmaceuticals North America, Inc., is based in Deerfield, Illinois.