FDA Warns About Risk of Bladder Cancer from Actos

Federal health regulators are warning that side effects of Actos, Takeda Pharmaceutical’s popular diabetes drug, may increase the risk of bladder cancer when it is taken for more than a year.

The FDA issued an Actos bladder cancer drug safety communication on Wednesday, indicating that new information will be added to the warning label for the diabetes drug to ensure consumers and the healthcare community are aware of the potential risk of bladder cancer from Actos.

The warning comes just days after France and Germany issued an Actos recall after a review of public insurance data identified an increased incidence of bladder cancer with Actos use. Other European countries are also reviewing the risks associated with Actos, and are expected to determine how to respond in the near future.

FDA officials began reviewing the potential Actos bladder cancer side effects in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug. Data from the study conducted by Takeda Pharmaceuticals, the makers of Actos, indicated that after 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance.

New Actos warnings are being required by the FDA, which indicate that use of Actos for more than one year may increase a patients’ chances of being diagnosed with bladder cancer. The warnings will also be added to other medications that contain pioglitazone, the active ingredient in Actos; including, Actoplus Met, ActoplusMet XR and Duetact.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.

Sales have increased in recent years, after a number of studies have suggested that Actos may be safer than its primary competitor, Avandia, which has been linked to an increased risk of heart attacks and deaths.

Last month, a study by Italian researchers found a disproportionate number of Actos bladder cancer reports in the FDA’s own Adverse Event Reporting System Records. However, that study did not establish a causal effect between Actos and bladder cancer.

The FDA reached its determination by studying data from Takeda’s ongoing 10-year Actos cohort study, involving 193,099 patients with diabetes. The agency has determined that a patient taking Actos for 12 months or longer had a 40% increased risk of developing bladder cancer. The risk increased with both dose size and duration of treatment. 

The agency said it will continue to evaluate the ongoing study and will look at other data as well.

Since information about the risk associated with Actos, a number of former users diagnosed with bladder cancer are considering pursuing a Actos bladder cancer lawsuit against Takeda Pharmaceuticals for failing to fully research the side effects of Actos or adequately warn about the potential risk of cancer.