Actos Warnings for Bladder Cancer Remain Inadequate

Austin Kirk

By Austin Kirk
Posted February 2, 2012


Although Takeda Pharmaceuticals has known that side effects of Actos increase the risk of bladder cancer they introduced and sold the medication without warning consumers or the medical community. The FDA required new label information to be added to the drug, but the Actos warnings for bladder cancer remain inadequate.

▸ INFORMATION: Actos Cancer Lawsuit

Actos (pioglitazone) is a medication approved for treatment of type 2 diabetes. Research has suggested that use of the medication for long periods of time may increase the risk of users developing bladder cancer.

As a result of the risk, many experts believe that any potential benefits provided by the medication are outweighed by the risk of bladder cancer, and there have been calls for Takeda Pharmaceuticals it issue an Actos recall. In fact, Actos was removed from the market in France and some other European countries due to the risk.

The Actos package insert and bladder cancer warnings (PDF) in the United States were updated in August 2011. New information was added to the “Warnings and Precautions” section, which indicates:

Bladder Cancer: Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder caner in pioglitazone users. The observational data further suggest that the risk increases with duration of use. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer.

While the new Actos warning label does now acknowledge the risk of bladder cancer, it remains inadequate information for consumers and the medical community given the severity of the health risk involved.

If Actos is to remain on the market, at a minimum, the FDA should force Takeda to place the bladder cancer information within an Actos “black box” warning, which would be featured prominently at the beginning of the label. Such a boxed warning is the strongest warning that can be placed on a prescription label, and it is warranted because it is important that every prescription for Actos be made with full knowledge of the risk.

Information should also be provided to consumers and the medical community that encourages a three to six-month review of the drug’s performance for each individual patient, as regulators have recommended in Europe. The potential Actos cancer risk could be reduced by appropriate patient selection and exclusion, as well as limiting long-term exposure to Actos, which may increase the chances of developing bladder cancer.


The Actos lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a lawsuit against Takeda over their failure to adequately warn about the risk of bladder cancer. Actos lawsuits allege that Takeda continues to put their desire for profits before patient safety by failing to recall Actos or provide adequate warning information.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

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