Having nearly eclipsed $5 billion in sales just two years ago, Actos (generic: pioglitazone) has established itself as the unquestionable flagship product of Takeda Pharmaceuticals. Accordingly, Actos has assisted in the treatment of type 2 diabetes for millions of patients around the world. Of significant concern, however, are previous studies that have established an association between Actos treatment and the development of severe complications. According to the studies, those receiving Actos treatment for two or more years may double their risk in developing an aggressive form of bladder cancer. These findings may cause prescribers to question whether the benefit-risk ratio of pioglitazone is still acceptable for patients diagnosed with diabetes.
Takeda Pharmaceuticals, the world renown Japanese pharmaceutical manufacturer, introduced Actos to the U.S. market on July 15, 1999. Following regulatory actions taken by the U.S. Food and Drug administration (FDA), Actos gained the Agency’s approval to be sold in America with the implications of regulating blood sugar levels in patients diagnosed with type 2 diabetes.
Actos is indicated for the use in patients diagnosed with type 2 diabetes, a condition in which the body is unable to utilize insulin properly, and therefore can’t regulate levels of sugar in the blood. Pioglitazone, the active ingredient in Actos, belongs to a group of drugs known as thiazolidinediones. As a thiazolidinedione, pioglitazone initiates an increase in the body’s sensitivity to insulin, a chemical that regulates levels of sugar in the blood. By doing so, those diagnosed with type 2 diabetes are better able to regulate their blood sugar levels.
Unfortunately, Actos treatment may coincide with the development of catastrophic complications. According to a government funded study, taking Actos for more than two years may double a patient’s risk of developing bladder cancer. Data provided by the study encouraged two prominent members of the European Union, France and Germany, to remove Actos from their markets. Each believed that the risk of bladder cancer was too significant to justify the benefits of Actos treatment.
Quantifying the risk evaluation, is a recent study conducted by Canadian researchers. Their data was published online by the British Medical Journal (BMJ). Their research included a comprehensive analysis of more than 115,000 British patients who had been treated with Actos between 1988 and 2009. Their study acknowledged that Actos use of two years or more was associated with 88 extra cases of bladder cancer per 100,000 person years. This rose to 137 extra cases among patients who had taken more than 28,000 milligrams of the drug.
In addition to the recent study, an accompanying editorial acknowledged that these findings would cause healthcare professionals and consumers alike to reevaluate their stance on Actos. Dominique Hillaire-Buys and Jean-Luc Faillie from the Department of Medical Pharmacology and Toxicology in Montpellier, France believe “Prescribers who are ultimately responsible for therapeutic choices can legitimately question whether the benefit-risk ratio of pioglitazone is still acceptable for their patients with diabetes.”
Do I Have an Actos Bladder Cancer Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Actos bladder cancer lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has been diagnosed with bladder cancer after taking Actos you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.