Multiple medical studies link the Type 2 diabetes medication Actos to the onset of bladder cancer. That life-threatening side effect, as well as heart failure, led thousands of people to seek compensation for damages caused by the drug. Drug maker Takeda Pharmaceuticals in April 2015 settled about 9,000 Actos-related lawsuits for $2.37 billion.
Each year in the United States, about 70,000 people are diagnosed with bladder cancer. If caught before it spreads, the cancer can usually be treated. However, it has a high recurrence rate. Takeda does not acknowledge any links between Actos and bladder cancer.Learn More
The FDA considers the risk of congestive heart failure from Actos to be significant enough to require a black-box warning on the drug's label. Avandia, another drug in the same class, is also known to cause severe heart problems.Learn More
Takeda and Eli Lilly launched Actos, a thiazolidinedione (TZD). Pre-approval studies showed tumors in rats given the drug. Its label said the relationship between the tumors in rats and possible tumors in humans is "unclear."
Two clinical studies that were a part of Takeda's PROactive study revealed a higher percentage of bladder cancer in people taking Actos as opposed to another drug.
Eli Lilly stops marketing Actos. The drug's label is changed to add the findings from a two-year study that showed bladder tumors in rats given a high dose of Actos.
FDA begins reviewing data from 10 year Actos study
French study finds increased bladder cancer risk in patients taking Actos. The drug is pulled off market in France, and Germany recommended not starting Actos in new patients.
FDA releases safety announcement warning that using Actos for over a year "may be associated with an increased risk of bladder cancer."
First Actos bladder cancer suits are filed.
Takeda settles about 9,000 claims filed about Actos for at least $2.37 billion, one of the largest Big Pharma settlements in U.S. history. As part of the agreement, the drug maker does not admit any wrongdoing.
Louisiana resident Darin Andrews filed a lawsuit against Takeda in 2012 after being diagnosed with bladder cancer several months after he started taking Actos. His lawsuit states the drug was "inadequately tested, dangerous to human health and lacked proper warnings."
Edwene Person's husband, James, was diagnosed with and died from bladder cancer after taking Actos. Her lawsuit states that James' injuries were a result of the defendants' "wrongful conduct, acts, omissions, [and] fraudulent misrepresentations."