Did Taking Actos Cause Your Bladder Cancer?

If you or someone you know has developed bladder cancer after taking the diabetes drug Actos for more than one year, you may be able to file a claim against Actos manufacturer, Takeda Pharmaceuticals, for compensation. Damages may include medical expenses, loss of income, and pain and suffering. Please contact us today for a free consultation during which we can discuss your experience and the best course of action for your case.

Contact us today for a free consultation. (855) 88-ELDER

June 2011: FDA Warns of Serious Complications

Read the warning here.

Actos Linked to Increased Risk of Bladder Cancer

According to an FDA Warning, those who take Actos for more than a year are 40 percent more likely to develop bladder cancer than those never exposed to Actos. Multiple studies have shown a connection between instances of bladder cancer and users who took Actos for more than one year or were exposed to the highest cumulative dose. In addition to the FDA safety warning, a study in France between 2006 and 2009 supports that there is a statistically significant correlation between exposure to Actos and the occurrence of bladder cancer. After the study was released, the use of Actos was suspended in France. German health regulators have also advised their doctors not to write any new patients Actos prescriptions. These results are similar to those obtained in the United States by a Kaiser Permanente Northern California study. If you have relied on Actos to treat your type 2 diabetes, you do not have to accept bladder cancer as a terrible side effect. You can file a claim against Takeda Pharmaceuticals to receive the compensation you deserve.

Safety Announcement

[6-15-2011] The U.S. Food and Drug Administration (FDA) is 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.

This safety information is based on FDA’s review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study1, described in FDA’s September 2010 ongoing safety review and in the Data Summary below. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.

FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.

    FDA recommends 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 benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.

FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.

Additional Information for Patients

  • There may be an increased chance of having bladder cancer when you take pioglitazone.
  • You should not take pioglitazone if you are receiving treatment for bladder cancer.
  • Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
  • Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
  • Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
  • Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals

  • Do not use pioglitazone in patients with active bladder cancer.
  • Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of glycemic control versus unknown risks for cancer recurrence with pioglitazone should be considered in patients with a prior history of bladder cancer.
  • Counsel patients to report any signs or symptoms of blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer.
  • Encourage patients to read the Medication Guide they get with their pioglitazone medicine.
  • Report adverse events involving pioglitazone medicines to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of this page.

Contact us today for a free consultation and case review. A member of our legal staff will return your inquiry promptly and schedule an appointment.

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