Japanese Company Takeda Pharmaceuticals America, Inc. (“Takeda”), the manufacturer of the Type II diabetes drug Actos, is one of the latest to join the growing list of pharmaceutical drug giants at the center of controversy. Recent studies linking Actos to an increased risk of bladder cancer expose the company to the risk of thousands of lawsuits.
Actos was approved by the FDA in 1999 as a treatment for patients with Type II diabetes to help lower a patient’s sensitivity to insulin in order to increase blood sugar levels. Actos became the world’s best-selling diabetes medication following the fall of rival drug Avandia, which in 2007 was linked to an increased risk of heart attack and other cardiovascular problems. In 2010, Actos had sales of $4.6 billion, making it Takeda’s number one selling drug, according to Business Week.
Recent studies, however, have found that Actos users are anywhere from 22% to 40% more likely to be diagnosed with bladder cancer than other diabetes drug users, and doctors are now being advised to prescribe the drug to patients with caution. Following this alarming statistic linking Actos and bladder cancer, in June 2011, health officials in both France and Germany ceased sales of the popular diabetes drug Actos because of the startling link of bladder cancer risk. In the United States, the Food and Drug Administration (“FDA”) issued a warning letter in June 2011 to advise that patients who take the Type II diabetes drug Actos for more than one year or those who are treated with the highest doses of the drug Actos are more likely to develop bladder cancer than those who take other diabetes medications. Despite the FDA’s warning about the link between Actos and bladder cancer, no recalls have been issued.
For patients that take Actos, the FDA advised that those individuals should be alert for signs and symptoms of bladder cancer, including blood or red color in the urine, urgent need to go to the bathroom, frequent small amounts of urination, frequent urinary tract infections, pain while urinating, and back pain or lower abdominal pain.
The first Actos lawsuit related to bladder cancer was filed early in August 2011 on behalf of a woman who was diagnosed with the disease in 2009 after taking Actos for more than 10 years. Lawyers and legal analysts have been predicting that thousands of lawsuits may eventually be filed on behalf of patients who are diagnosed with bladder cancer after taking Actos.
On August 31, 2011, a Motion for Coordinated Proceedings was filed, moving for an Order to transfer all currently pending and all subsequently filed Actos bladder cancer cases to the United States District Court Southern District of Illinois before Honorable G. Patrick Murphy. As of August 31, 2011, there were 11 actions pending in 8 district courts, including the Southern District of Illinois, Western District of New York, Eastern District of New York, Southern District of New York, Northern District of New York, New Jersey, Northern District of Ohio, and Central District of California.
Disclaimer: All use of the Actos mark is for informational and product identification purposes only. This post should not be taken as either medical or legal advice, but instead should act as a resource in providing general information that may be useful to the general public. Pope McGlamry is not affiliated with the manufacturer of Actos®, Takeda Pharmaceutical, or its distributors.