New Actos Bladder Cancer Warning

Facing thousands of legal challenges about its type 2 diabetes drug Actos, Takeda Pharmaceuticals unveiled the drug’s new warning label following an announcement last week from Canadian officials about the Actos-bladder cancer link.



On April 16, Takeda officials penned a “Dear Doctor” letter to health-care professionals, warning them of the risk. The letter says, “findings from new studies reveal that there is a potential increased risk of bladder cancer in patients treated with pioglitazone-containing products.”

The letter points to several studies that indicate a higher bladder cancer risk for patients taking the diabetes medicine for longer than a year. Two three-year studies that used either pioglitazone or a placebo showed that there was a 44 percent incidence of bladder cancer in patients taking pioglitazone compared to 14 percent in patients not taking the drug.

All of this comes after the recent official announcement from Health Canada, the country’s national healthcare regulation group, that taking Actos for longer than a year is linked to bladder cancer. Although Takeda has repeated denied a link, the drug’s label now carries the warning in Canada and the United States. Other countries, such as Germany and France, pulled Actos from the shelves, making it only available with a special prescription.

The letter from Takeda to Canadian doctors goes on to say, “ Actos is now contraindicated in patients with active bladder cancer, a history of bladder cancer or under investigation for macroscopic hematuria (blood in the urine.)” The warning says patients should be assessed before taking the drug. Risk factors include age, smoking history, a family history of bladder cancer, cancer treatments, radiation treatments and chemical exposure.

Patients who are taking Actos and have blood in the urine or any symptoms of urinary problems are urged to seek immediate medical attention.




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