The lawsuit alleges that Actos’ manufacturer, Takeda Pharmaceuticals North America (and other entities including: Takeda Global Research & Development Center Inc., Takeda Pharmaceuticals Company Ltd., Takeda Pharmaceuticals America, Takeda San Diego Inc., Takeda Pharmaceuticals International Inc and Eli Lilly and Company), was negligent for not providing any warnings regarding the increased bladder cancer risk associated with Actos use.
Connection between Actos and bladder cancer
The lawsuit against Takeda comes on the heels of an announcement and product labelling change ordered by the FDA associating long-term Actos use with a substantial increase in the development of cancer in the bladder.
Much of the concern is related to a study of Actos users over a 10 year term which firmly established that people taking Actos were 40% more likely to develop bladder cancer than those not taking the drug. The study published in the journal Diabetes Care further concluded that bladder cancer rates increased as the duration of use and dosage levels increased.
Similar studies conducted by researchers in France confirmed the increased risk of bladder cancer in Actos users compared with other types of diabetes drugs. In response to the European study, both France and Germany have pulled Actos from the market altogether.
The increased popularity of Actos
After the medical community discovered the association between heart problems and Avandia usage in diabetic patients, many doctors switched their patients to Actos as a safer alternative. The popularity of Actos quickly increased to the point that it was the most popular drug used to treat people with diabetes. In 2010 alone, more that 2.3 million people were prescribed Actos or similar medications containing pioglitazone.
The popularity of Actos has been extremely good for its manufacturer, Takeda Pharmaceuticals. In the past year alone, sales of Actos have produced revenues of $3.4 billion for Takeda!
Takeda’s duty to protect its users
Given the prevalence of Actos use, it is likely that we are only in the initial phase of discovering how many people have been irreparably harmed by this drug. As early lawsuits are initiated, we will likely learn a good deal more about just how much Takeda knew about the increased rates of bladder cancer in people using their drug.
Given the long-term studies that have already demonstrated a clear connection between Actos and bladder cancer, Takeda’s failure to warn seems apparent.
Legal options for Actos users who have developed bladder cancer
Bladder cancer is a painful, embarrassing and potentially fatal disease. Depending on when the disease is diagnosed, patients may face years of invasive treatments such as: chemotherapy, radiation treatment, surgery or immunotherapy. In lawsuits against Takeda, damages can be recovered for all related medical care, pain and even death.
Rosenfeld Injury Lawyers remain committed to fully protecting the legal rights of those who have suffered following Actos usage. We have a team of medical experts to effectively screen cases and help move cases forward as quickly as feasible. Call our office or fill out the contact form and we will provide you with a consultation regarding your rights.
Related Actos Information:
Lawsuit accuses diabetic drug manufacturer Takeda of not warning of risks of bladder cancer The Louisiana Record September 16, 2011
Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration, The New England Journal of Medicine by Janet Woodcock, M.D., Joshua M. Sharfstein, M.D., and Margaret Hamburg, M.D., N Engl J Med 2010; 363:1489-1491October 14, 2010
Risk of Bladder Cancer Among Diabetic Patients Treated With Pioglitazone (pdf) DIABETES CARE, VOLUME 34, APRIL 2011