Active Ingredient in Actos Still Being Linked to Bladder Cancer
Actos is a medication that is prescribed to regulate blood sugar levels in those who have been diagnosed with Type 2 diabetes. Though the drug has been on the market for almost twenty years, its use is extremely controversial because its long term use has been linked to a number of serious health complications. Among these is an increased risk of bladder cancer. This has led to numerous personal injury Actos lawsuits being filed against the company’s manufacturer, Takeda Pharmaceuticals, and to the U.S. Food and Drug Administration (FDA) requiring that the drug’s label include a warning about the risk. Though Takeda has argued that their medication is safe, pointing to some studies that indicate that there is no causal link between the drug’s active ingredient and bladder cancer, more recent studies have continued to suggest a link.
The active ingredient in Actos is pioglitazone. Since concerns have been raised about the link between pioglitazone and bladder cancer, the FDA has asked Takeda to perform a 10-year study of their drug. In addition to reviewing interim results of this study, the agency has also reviewed other studies that have been done since the Actos lawsuits began to be filed, and these results have continued to point to a link. One study published in the BMJ in early 2016 reported a 63% higher risk for bladder cancer following patients being treated with pioglitazone. That study indicated that the longer the medication was taken and the higher the dose, the greater the risk. Another study published in The New England Journal of Medicine identified an additional source of concern. Patients taking the medication were shown to gain more weight, experience water retention and swelling, and be at higher risk for serious bone fractures leading to surgery or requiring hospitalization.
As a result of these negative studies and in spite of some other research drawn from a 10-year study drawn from the database of Kaiser Permanente of Northern California, the FDA has indicated that they continue to believe that there may be a link between pioglitazone and an increased risk for bladder cancer, and that they plan to order that the medication’s labeling add the newer study results to its list of warnings.
Prior to the FDA’s intervention, Takeda Pharmaceutical’s own preclinical trials had already shown that in animal studies there was evidence of a link between the medication and bladder tumors. There have been thousands of Actos lawsuits filed against the drug manufacturer, as well as against its partner Eli Lilly, seeking compensation for the damages suffered by those who were prescribed the drug and who were later diagnosed with bladder cancer. Individuals have been awarded millions of dollars in jury trials and in April 2015 the company settled thousands of bladder cancer claims for over $2 billion dollars. If you have been harmed by Actos, the attorneys at Jonathan Perkins Injury Lawyers can help. Contact us today to set up a free consultation.