A recent Actos drug lawsuit alleges that the diabetes medication increases the risk of developing bladder cancer.

Plaintiff Fredrick W. and his wife Lois W. recently filed an Actos drug lawsuit against various Takeda Pharmaceuticals subsidiaries and Eli Lilly.

The couple says that after taking Actos, Fredrick was diagnosed with bladder cancer, which he claims was a direct result of his treatment with the diabetes medication. He has since filed an Actos drug lawsuit.

Actos is a type-2 diabetes medication that was launched by Takeda Pharmaceuticals and Eli Lilly in 1999. The drug is part of the insulin-sensitizing diabetes medications known as thiazolidinediones (TZDs). Actos is also sold in combination with other diabetes drugs such as metformin and glimepiride.

However, the Actos drug lawsuit claims that the diabetes medication can increase the risk of developing bladder cancer.

“As a result of the defective nature of Actos, persons who were prescribed and ingested Actos for more than twelve months, including Plaintiff, were at increased risk for developing bladder cancer, have suffered and may continue to suffer from bladder cancer,” the Actos drug lawsuit claims.

Before Actos was approved by the U.S. Food and Drug Administration, a two-year carcinogenicity study was conducted on rats. This study allegedly showed that drug-induced tumors were possible in male rates which blood drug levels equivalent to those resulting from a clinical dose.

In 2005, the results of a separate three-year cardiovascular study showed that there was a “statistically significant demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators”.

Despite the results of these studies, Takeda allegedly chose not to warn consumers of the risks associated with bladder cancer in order to protect their profits and prevent regulatory actions.

“Defendants willfully, wantonly and with malice withheld the knowledge of an increased risk of cancer in users of Actos to prevent any chance of its products’ registrations being delayed or rejected by FDA,” the Actos drug lawsuit claims.

However, the alleged deception did not last. In September 2010, the FDA announced that it was reviewing the results of an ongoing ten-year study evaluating the link between Actos and the development of bladder cancer. The five-year interim analysis reportedly showed that the risk of developing bladder cancer reaches statistical significance after 24 months of treatment with Actos.

In June 2011, after international regulatory bodies suspended the use of Actos, the FDA announced that the use of Actos for over one year may increase the risk of bladder cancer. The agency then ordered that this information be added to Actos labeling to inform consumers of the risks.

Despite regulatory actions and scientific results showing that Actos was linked to bladder cancer, Takeda allegedly refused to recall the drug or warn consumers. The Actos drug lawsuit claims that if Fredrick had been warned about the risks associated with the medication, he and his doctor would not have chosen to treat his diabetes with Actos – a choice which may have saved him from bladder cancer.

The Actos Drug Lawsuit is Case No. 3:18-cv-05977 in the U.S. District Court for the Western District of Washington.