- New 10-year data show that taking Takeda and Eli Lilly's type 2 diabetes drug Actos (pioglitazone) does not increase the risk of bladder cancer, contradicting findings from a five-year interim analysis.
- A court ruling in April resulted in $9 billion in punitive damages in response to claims that Takeda and Lilly hid potential Actos-related cancer risks.
- Lilly and Takeda are appealing the prior court decision.
In 2011, the FDA issued a Drug Safety Communication citing the link between Actos and an increased risk of bladder cancer. According to the communication, results of a five-year interim analysis showed that patients who took Actos for 12 months had a 40% increased risk of bladder cancer. At that point, Actos' label was updated with a black box warning. Numerous studies have been conducted showing an increased risk of bladder cancer in patients taking the drug, including one that showed an 83% increased risk.
Now, however, Lilly and Takeda have completed 10 years of post-marketing surveillance and started to compile the study data, as requested by the FDA. The 10-year results show no statistically significant correlation between Actos and bladder cancer risk. Type 2 diabetes patient advocates hailed the findings, asserting that Actos is a "valuable treatment" option for diabetics.