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Actos drug maker Takeda Pharmaceutical Co. Ltd. was hit in California yesterday with what is expected to be the first of thousands of lawsuits accusing the company of failing to warn customers that taking its diabetes drug Actos could lead to a severe and aggressive form of bladder cancer. PREVIOUS ARTICLE
The lawsuit alleged that Japan-based Takeda concealed studies that showed a connection between prolonged use of Actos, a drug used to improve blood sugar control in adults with Type 2 diabetes, and increased risk of bladder cancer.
Before its approval by the U.S. FDA in 1999, the complaint claims Actos underwent a study on male and female rats. Researchers found drug-induced tumors in many of the male rats, but Takeda concealed these results to avoid a delay in FDA approval.
In one other study, the drug company allegedly became aware that a significantly higher percentage of cases of bladder cancer occurred in patients receiving Actos versus patients who underwent other diabetes treatments.
“Neither during the study nor in the actual final paper did the researchers or defendants publish these statistically significant increases of bladder cancer,” the complaint said.
The lawsuit stated that patients who used Actos for more than 12 months were 40 percent more likely to have bladder cancer. That resulted in 27.5 excess cases of bladder cancer per 100,000 people.
“With the knowledge of the true relationship between long-term use of Actos and developing bladder cancer, rather than take steps to pull the drug off the market, defendants promoted Actos as a safe and effective treatment for Type 2 diabetes,” the complaint said.
In June, the FDA issued a safety announcement that explained the correlation between Actos and bladder cancer. They also ordered drug companies to add the data to warning labels on their drugs that contain pioglitazone.
Takeda declined to comment.
Source: Berck v. Takeda Pharmaceuticals, Inc.,