Diabetes Drug Actos Linked to Increased Risk of Bladder Cancer

Actos is a popular medication for the treatment of type-two diabetes that was originally approved for sale in the United State in July of 1999.  Originally licensed to Takeda Pharmaceuticals, USA, the medication has had a checkered history.  In 2007, the FDA required the makers of Actos to increase the strength of the warning regarding the link between Actos and heart failure.  The FDA required the strongest possible warning, a "black-box" warning.  The increased strength of the warning is one example of inadequate research on the safety of Actos prior to marketing and selling it in the United States.

But the unknown dangers of Actos did not end at heart failure.  Several years later, after epidemiological studies in France and the United States, the FDA again required a warning to be added to Actos.  This time to inform the public about the increased risk of bladder cancer for Actos users.

Actos Linked to Bladder Cancer

In June of 2011, The U.S. Food and Drug Administration (FDA) announced that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. The FDA ordered that the information about the risk of bladder cancer would be added to the Actos label in the Warnings and Precautions section of the label.  In fact, this ruling applied to all pioglitazone-containing medicines, not just Actos.

The FDA based its decision to require Actos to carry the warning of increased risk of bladder cancer after reviewing the results of several studies in the United States and Europe.  The U.S. study was based on data collected from January of 1997 through August of 2008.  The results of the study were shocking - use of Actos for more than one year was shown to increase the chances of contracting bladder cancer by 40%; use over two years was shown to increase the risks of bladder cancer by 140%.

Prior to 2011, Actos did not carry a warning for bladder cancer.  Because Actos was found by the FDA to significantly increase the risk of bladder cancer and because Actos did not carry a warning for bladder cancer, those who contracted bladder cancer because of taking Actos may have a lawsuit against the drug manufacturer.

Actos Bladder Cancer Lawsuits

Soon after the link between Actos and bladder cancer was announced, Actos users that contracted bladder cancer began filing lawsuits in State and Federal Courts.  The first Federal Court case was tried in April of 2014 and resulted in a historic verdict for the Actos plaintiff.  The award of $9 Billion (later reduced by the Judge) demonstrated that the Jury felt strongly that Takeda possessed, and failed to share, information regarding the link between Actos and bladder cancer.

The Federal Court Actos Bladder Cancer cases have been consolidated by the Panel on Multi-District Litigation.  Bellwether trials are set to begin in 2016, but the Defendant has already announced that it will pay $2.4 Billion to settle more than 8000 cases filed by Actos users who contracted bladder cancer.

Representation for Actos Users with Bladder Cancer

If you or a loved one used Actos for more than one year and were later diagnosed with bladder cancer, contact the Actos Lawyers at the Merman Law Firm immediately.  There are time limits on your ability to file a claim and you must act immediately.