Frequently Asked Questions for our Actos Bladder Cancer

Actos is the brand name for the drug pioglitazone. The FDA approved the drug in 1999 for use in the treatment of Type II diabetes, the most common form of diabetes in North America.

Pioglitazone is also sold as:

• Actoplus Met (pioglitazone combined with another diabetes medication called “metformin”)
• Actoplus Met XR (extended release)
• Duetact (pioglitazone combined with the diabetes medication glimepiride).

Actos is manufactured by Takeda Pharmaceuticals of Japan and marketed in the United States by Eli Lilly & Co.

Actos (pioglitazone) has been linked to bladder cancer, which can be fatal if not diagnosed early enough. Even at its earliest stages, bladder cancer must be treated with surgery plus chemotherapy, immunotherapy or radiation.

A clinical trial showed that humans who took Actos developed bladder cancer at a rate 2.5 times greater than patients given a placebo.

In 2011, the FDA said complaints to its Adverse Event Reporting System (AERS) demonstrated “a definite signal for bladder cancer associated with [Actos] use” after 6 to 24 months of use.

Elsewhere, the French National Health Insurance Plan followed diabetes patients for up to four years and found a statistically significant increase in the risk for bladder cancer in patients using pioglitazone when compared to patients who took different diabetes medications, the FDA reports.

The FDA notified the public in June 2011 that using Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.

The FDA also directed that information about the risk of bladder cancer would be added to the “Warnings and Precautions” section of the label of pioglitazone-containing medicines. The patient guide for these medicines would also be revised to include information on the risk of bladder cancer, the FDA said.

The FDA advised doctors to not prescribe pioglitazone to patients who have active bladder cancer and to “use pioglitazone with caution” in patients who have a history of bladder cancer.

France suspended the use of Actos after a French National Health Insurance Plan study determined that pioglitazone increased patients’ risk of developing bladder cancer, and Germany has recommended that Actos not be prescribed to new patients.

The FDA says it continues to evaluate data from an ongoing 10-year epidemiological study of pioglitazone and will conduct a comprehensive review of the French study. The FDA will update the public when more information becomes available.

Meanwhile, The Driscoll Firm, LLC, is actively litigating lawsuits on behalf of diabetes patients who developed bladder cancer after taking pioglitazone in Actos, Actoplus Met, Actoplus Met XR and/or Duetact. Our firm continues to review and accept Actos cases.

The lawyers of The Driscoll Firm, LLC, can investigate your case and advise you of the legal options available to you. If you or a loved one of yours developed bladder cancer because they took Actos, we will pursue all compensation available to you.

The Driscoll Firm, LLC, has a successful record of representing clients who have been harmed by dangerous pharmaceuticals and medical devices. We will apply all of our firm’s skills and experience to your case.

We do not charge our clients unless and until we obtain a monetary award for them, either through a settlement or verdict. If we agree to pursue a claim on your behalf and secure a recovery for you, we will be paid a percentage of that recovery.

Contact The Driscoll Firm, LLC, at our toll-free phone number or through our online form to speak with a lawyer experienced with Actos claims.

Additional information about Actos (pioglitazone) from the Food and Drug Administration is available here:

• FDA safety announcement and update for patients
• FDA labeling revisions
• FDA 2010 safety review