Studies Link No. 1 Diabetes Drug To Bladder CancerNovember 7, 2011
According to reports, the maker of the world's bestselling diabetes drug, Takeda Pharmaceuticals Co. Ltd., is facing hundreds of lawsuits as suspicion grows that taking the pill for more than a year raises a patient's risk of bladder cancer. Reportedly, Takeda has already halted the sale of Actos, its diabetes drug, in Germany and France following pressure from regulators.
More recently, sources say the U.S. Food and Drug Administration and the European Medicine Agency have issued warnings about Actos' ties with bladder cancer. However, both agencies have allowed the sale of Actos to continue. Sources say doctors are being told not to prescribe Actos for people who have or have had bladder cancer. Further, sources say the warnings will probably limit diabetes patient drug choices and might spell the end of a once promising class of Type 2 diabetes drug. Reportedly, the Actos pill was appealing to patients because it consisted of a once a day pill which helped control blood sugar and had few side effects. Further, sources say Actos was thought to boost the effect of other diabetes drugs and even allow patients to reduce or delay insulin injections.
According to reports, Actos became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found to increase the risk of heart attacks in 2007. Sources say Avandia was banned in Europe and is heavily restricted in the United States. Reportedly, Actos became the No. 1 diabetes pill despite having links to heart failure and other serious side effects. According to reports, once Avandia was restricted, Actos' sales jumped from $2.9 billion in 2006 to $4.3 billion in 2010. Pharmaceutical industry sources say those billions may now shift to Takeda's rivals.
Recently, sources say the first of what attorneys predict to be thousands of lawsuits were filed in courts across the United States of America. Reportedly, the lawsuits allege the drug Actos, sometimes fatally, triggered bladder cancer in patients who took the drug daily for years.
Reportedly, Nancy Rios, a 54 year old hospital secretary, is suing Takeda for her recurrent bladder cancer after taking the drug Actos for more than a decade. Nancy says she was diagnosed with bladder cancer in 2009 and has had two surgeries to remove tumors. Nancy says she is worried about missing work and not being able to pay her medical bills. Nancy's attorney, Paul Pennock, has commented that "when a manufacturer distributes a drug, they owe it to the public to ensure that their product is safe for use and it appears that Takeda Pharmaceuticals failed to fulfill that fundamental duty."
Sources say that many law firms across the country are undertaking the necessary preparation to handle Actos Cases. Reportedly, Takeda has declined to comment on the lawsuits. However, the Japanese company has issued statements that it's committed to keeping Actos available for patients who need it. According to a Takeda spokeswoman, an April study in the journal Diabetes Care found Actos "used for more than two years was weakly associated with increased risk."
However, sources say the FDA has analyzed data from the first five years of a 10-year Actos safety study Takeda begun in 2002. According to the FDA, the risk of bladder cancer was 40 percent higher for patients taking Actos for at least a year. Sources say this number amounts to an extra 28 cases a year for every 100,000 people taking Actos.
According an analyst and professor at University of Michigan's Ross School of Business, the new safety questions are "a big deal" for Takeda, particularly since the Actos patent expires in August 2012. They mean Actos will not make as much money as expected in the final months, and they dampen prospects for two experimental drugs Takeda was hoping would succeed Actos.
However, pharmaceutical sources doubt the cost of the bladder cancer litigation will hit the level of Vioxx. The drug Vioxx is a painkiller that was pulled off the market in 2004 because it doubled risk of heart attacks and strokes which triggered more than 50,000 lawsuits and concluded with a $4.85 billion settlement to end most of them.
Medical sources say whatever the outcome of the Actos litigation, diabetes patients and their doctors will be considering their options now. According to a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, a more long-term data on the effects of Actos is needed. The professor feels that it is not clear if the bladder cancer risk is real, but Actos and Avandia both are linked to heart risks, weight gain and possibly bone loss and fractures. The professor says that Actos should only be considered after patients have exhausted all other options.
If you believe you or any of your loved ones have been affected by the drug Actos or have been diagnosed with bladder cancer after taking Actos, please contact the Amaro Law Firm locally at 713-864-1941 or toll free at 877-292-8797 for information on how we may help you.