Bladder Cancer Risk Puts Actos in Legal Crosshairs

Litigation involving the drug <"">Actos (pioglitazone) is heating up, as hundreds of bladder cancer victims are expected to file personal injury lawsuits against Takeda Pharmaceuticals in the coming months. Actos has been the subject of warnings in both the U.S. and Europe because of a suspected bladder cancer link.

Since warnings were issued in June, several Actos bladder cancer lawsuits have been filed in U.S. Courts. One of the first was filed by Nancy Rios, 54, who took Actos for nearly a decade. According to the Associated Press, Rios was diagnosed with bladder cancer in 2009, and has undergone two surgeries to remove tumors. She has missed work and is worried about paying her medical bills. She may end up losing her bladder, and could require chemotherapy.

Rios’ lawyer told the Associated Press that his firm has 100 Actos bladder cancer lawsuits pending, and is receiving up to 40 inquiries per week from potential plaintiffs.

A lot of people take Actos. Its sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year. According to the Associated Press, Actos got a big boost when a rival medication, Avandia, was linked to an increased risk of heart problems in 2007, ultimately resulting in a European ban and tough restrictions in the U.S. Though Actos has also been linked to heart problems, it became a favorite among doctors and patients because it makes the body more sensitive to insulin, only needs to be taken once per day, and even allowed patients to reduce or delay use of injected insulin, the Associated Press said.

But for a while, troubling signs have been cropping up pointing to a possible connection between Actos and bladder cancer. Last September, the U.S. Food & Drug Administration (FDA) decided to begin a safety review of Actos, after 5-year results from a study conducted by Takeda showed an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.

This past May, a review of adverse events reported to the FDA database, published in Diabetes Care, suggested a “disproportionate risk” of bladder cancer associated with Actos, in comparison with other anti-diabetics. The study looked at a half million reactions to various diabetes medications reported between 2004 and 2009. The reports included 138 people who developed bladder cancer, with the most – a fifth of the cases – occurring in Actos patients.

In June, the FDA mandated that new information regarding bladder cancer be added to the “Warnings and Precautions” section of the Actos label, based on the review of the Takeda study that it started in September 2010. Just days earlier, France, and then Germany, suspended sales of Actos in those countries, after a separate study commissioned by the French government found an increased risk of bladder cancer among people who took Actos the longest, and at the highest cumulative doses.

The European Medicines Agency has also called for new bladder cancer warnings for Actos. Its recommendations include a six month review for every patient taking Actos. A statement from the agency also said Actos bladder cancer risks may be reduced by appropriate patient selection and exclusion.

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