The U.S. Food and Drug Administration (FDA) has updated its review of the type 2 diabetes medication Actos (generic: pioglitazone), confirming that users of the drug may face an increased risk of bladder cancer.
Free Confidential Lawsuit Evaluation: If you or a loved one got bladder cancer after taking Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
December 15, 2016 – FDA added a bladder cancer warning to Actos labels in June 2011, based on interim results from a 10-year study of patients with type 2 diabetes in Kaiser Permanente’s database. The findings suggested that the cancer risk rose as the dose and treatment duration increased. The updated labeling warns doctors not to prescribe Actos to patients with active bladder cancer and to use caution when giving the drug to patients with a history of the disease.
A pair of subsequent studies published in 2014 and 2015 refuted the link between Actos and bladder cancer. The latter study, published in the Journal of the American Medical Association (JAMA), looked at the research that led to FDA’s 2011 Actos label change, but was unable to find the cancer signal detected in the interim results.
However, a retrospective cohort study published in the BMJ in August 2016 found a 63% increased risk for bladder cancer with pioglitazone, with longer duration of use and larger doses increasing the risk.
FDA confirmed the Actos / bladder cancer link Monday, stating that the drug’s labeling will again be updated to describe the additional studies reviewed by the agency.
In December 2011, thousands of Actos bladder cancer lawsuits were consolidated into a multidistrict litigation (MDL No. 2299) that is still underway in the U.S. District Court, Western District of Louisiana. Takeda later agreed to a $2.4 billion Actos settlement that ultimately resolved more than 8,000 such claims. Plaintiffs eligible to participate in the settlement included patients who were prescribed a pioglitazone-containing diabetes drug including Actos, ACTOplus Met, ACTOplus Met XR, or Duetact prior to December 1, 2011, and who were diagnosed with bladder cancer prior to August 28, 2015.
Do I Have an Actos Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. We are handling individual litigation nationwide and currently accepting new bladder cancer cases in all 50 states.
Free Case Evaluation: Again, if you got bladder cancer from Actos side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.