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Health Canada Announces Actos Bladder Cancer Warning

Apr 23, 2012 | Parker Waichman LLP

Canadians are now being officially warned about the risks of bladder cancer associated with taking the Type 2 diabetes drug Actos.

According to The Canadian Press, Health Canada and Takeda Canada have issued a statement alerting the public there about this specific risk now being linked to this top-selling diabetes drug treatment. This statement follows others issued elsewhere around world, including the U.S. where many Actos users have already begun developing bladder cancer and have filed lawsuits against Takeda Pharmaceuticals for failing to warn of this side effect.

Actos is a top-selling treatment for Type 2 diabetes. It has supplanted a previous drug, Avandia, atop the market after that drug was found to carry its own set of serious and life-threatening side effects and because attention was mostly focused on Avandia’s woes, research on the effects of Actos had largely gone unnoticed or unfinished. Now that it’s topping the market and so many people taking Actos in place of Avandia, more attention is being drawn to its side effects.

Though this warning comes a few months after other statements made on Actos’ link to bladder cancer, the report indicates the drug had already fallen out of favor in Canada. A researchers at Toronto’s St. Michael’s Hospital said many doctors have been taking patients off Actos for several years so the warning doesn’t come as much of a surprise.

Furthering this theory is the fact that Actos has been placed in a group of drugs in the province of Ontario listed as “exceptional access” meaning only select patients can receive it, usually only those who’ve gotten clinical benefit from the drug in the past.  In most cases, Actos should not be considered the go-to treatment, especially initially, for treating Type 2 diabetes.

In Health Canada’s statement, it cites an ongoing clinical trial of Actos being conducted by Takeda, the makers of the drug. In that study, patients not taking the drug have developed bladder cancer at a rate of 7 in 10,000 patients. Those taking Actos developed the mostly irreversible disease at the rate of 10 in 10,000.

The agency also notes that people taking Actos for longer periods of time appear to be facing the greatest risk of developing bladder cancer. People currently suffering from bladder cancer or have a history of bladder cancer in their family should also avoid taking Actos, Health Canada warned.

Physicians can determine who is most at risk of bladder cancer by considering several factors, including family history, whether the patient is a smoker or is exposed to some chemicals or radiation in the workplace.  


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