Takeda Pharmaceuticals is the maker of Actos® (pioglitazone), which is a treatment for Type II Diabetes. Actos (R)® was approved by the FDA in 1999. It has been prescribed to more than 10 million users worldwide since its approval. However, increased rates of bladder cancer have since been linked to the prolonged use of Actos®, and Takeda is now facing consequences for allegedly failing to adequately warn its users of the risks associated with taking Actos®.
Actos® treats Type II Diabetes by controlling and balancing blood sugar. As a result of the popularity of the drug, Actos® accounted for nearly $4.5 billion in sales in 2011, representing about 27% of the overall revenue for Takeda Pharmaceuticals. However, studies began to emerge indicating a link between Actos® and bladder cancer. A French study between 2006 and 2009 indicated users who had taken Actos® had a 22% greater likelihood of developing bladder cancer than those who have never used Actos®. These results led the French and German governments to recall Actos® in June 0f 2011. The FDA did not recall the drug, but it did mandate Takeda Pharmaceuticals to include a warning of the increased risk of bladder cancer on the Actos® label.
The FDA continues to investigate the risks of Actos® as relates to bladder cancer. A study in the January 2013 issue of Diabetic Medicine showed increased risks of bladder cancer in Actos® users of approximately 20%. Additional studies were conducted in 2014 and 2015 (Journal of American Medical Association) which did not show any leads into bladder cancer. However, a subsequent study by The BMJ indicated a 64% higher risk for bladder cancer, especially taken over a long period of time in higher dosages. This new data led the FDA to update the warning labels once more in December 2016.
Users of Actos ® may not be aware of the possible association between the drug and bladder cancer. Therefore, any current or past users should be aware of the possible side effects, such as:
- Blood or blood clots in the urine
- Frequent need to urinate
- Pain during urination
- Abnormal color of urine
- Frequent urinary tract infections
- Back or abdominal pain
Contact Our Trusted Louisville Medical Malpractice Attorney Today
There are allegations against Takeda Pharmaceuticals, claiming the company was aware of the increased risks before the FDA imposed the mandatory label warning. If you or someone you know has had serious health problems which can be linked to the use of Actos®, you should consider reaching out to a Louisville medical malpractice lawyer you can rely on in your time of need, such as ours at Brett H. Oppenheimer, PLLC.
Please don’t hesitate to schedule an initial consultation with a member of our team by sending us a message online or calling (502) 242-8877.
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