In the continuing controversy over the link between the type 2 diabetes drug Actos (pioglitazone) and bladder cancer, a new lawsuit was filed in June 2016 by a man who was diagnosed with bladder cancer after taking Actos for six years.
According to the Louisiana Record, the lawsuit alleges that the man’s bladder cancer is directly linked to his Actos use. The legal complaint says he suffers permanent injuries, pain, and mental anguish.A number of Actos lawsuits have been consolidated for pretrial proceedings in a multidistrict litigation (MDL) in the federal court for the Western District of Louisiana. As of June 15, 2016, there were more than 4,500 lawsuits consolidated in the MDL. Court documents in pending Actos cases claim that Takeda Pharmaceuticals concealed data linking the use of Actos to the development of bladder cancer.
Studies of the possible link between Actos and bladder cancer have thus far not yielded definitive proof, but research has shown increased bladder cancer risk among those who have taken the drug for more than one year. The risk also seems to increase with a cumulative dosage of 28,000 mg or more.
In June 2011, medical regulators in France and Germany suspended sales of Actos because of the possible link to bladder cancer. The decision followed a study commissioned by the French Medicines Agency that found that people taking Actos were more likely to develop bladder cancer, an aggressive form of cancer. The study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009, and 1.3 million other diabetics who were not taking Actos. The study found that the risk of bladder cancer was about 22 percent higher among those taking the drug compared with diabetics taking other medications. The bladder cancer risk was highest in those receiving a cumulative dosage of 28,000 mg or more during the study period.
A study published earlier this year in the BMJ (British Medical Journal) found that Actos is linked to a 63 percent increased risk of bladder cancer and, further, that the risk is specific to Actos and is not seen in other drugs in its class. The researchers also found that the duration of Actos use and the cumulative dose were factors in the bladder cancer risk.
On April 28, 2016, Takeda agreed to a settlement program that would pay out $2.37 billion if 95 percent of eligible plaintiffs agree to participate and $2.4 billion if at least 97 percent choose to participate. To be eligible for the settlement program, the individual must have been prescribed an Actos medication (Actos, ACTOplus Met, ACTOplus Met XR, or Duetact) before December 1, 2011, and must have been diagnosed with bladder cancer before April 28, 2015, Bloomberg News reports. Each eligible plaintiff could receive more than $296,000, with the amount adjusted for factors such as age, smoking history, and exposure to toxins.