The study was published in the British Journal of Clinical Pharmacology (12/10/13; online ahead of print) and involved researchers conducting a meta-analysis of medical literature linking the use of thiazolidinediones (a class of drug that includes Actos) and the development of bladder cancer. Among 230 citations, researchers found 18 studies, including five randomized controlled trials and 13 observational studies.
Researchers found an increased risk of bladder cancer in patients with the highest doses of pioglitazone (the generic version of Actos) and in patients who either took Actos between 12 and 24 months or more than 24 months. Furthermore, the researchers found a higher overall risk of bladder cancer in patients who used pioglitazone than those who used rosiglitazone (Avandia).
“A modest but clinically significant increased risk of bladder cancer with pioglitazone was found that appears related to cumulative dose and duration of exposure,” researchers wrote. They further recommended that use of pioglitazone be limited to shorter durations.
The study was published just more than a month before the first federal Actos bellwether trial began in Louisiana federal court. The lawsuit, and other pending lawsuits, alleges patients developed bladder cancer after using Actos to treat their diabetes. Plaintiffs claim Takeda either ignored or downplayed the risk of developing bladder cancer.
Possibly damaging Takeda Pharmaceutical’s (maker of Actos) defense is a ruling from the judge that Takeda must allow a jury to hear claims that files related to Actos were deliberately destroyed.
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Actos bellwether trials have gone ahead in state courts, with conflicting results, including an award to a plaintiff that was overturned by the judge and an award to the plaintiff that was reversed because the jury found the plaintiff contributed to his development of cancer.
Consolidated federal Actos lawsuits are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana. The first federal bellwether case to go to trial is Allen v. Takeda Pharmaceuticals North America Inc., 12-cv-00064, U.S. District Court, Western District of Louisiana.