Health Canada Issues Actos Warning

Ottawa, CanadaHealth Canada has issued a warning about the risk of Actos bladder cancer, following in the footsteps of the US Food and Drug Administration (FDA). As Actos side effects lawsuits mount, and concerns grow about a possible link between Actos and bladder cancer, some experts recommend doctors and patients stay away from the medication.

The warning was issued by Health Canada following a safety assessment of Actos. According to Health Canada, taking Actos may increase the patient's risk of developing bladder cancer. Health Canada now requires Takeda update the Actos warning label to reflect the risk. Studies are currently being done on Actos to determine whether or not the drug is actually associated with an increased risk of cancer. According to The Canadian Press (4/20/12), a five-year data review of a 10-year study conducted by Takeda suggests there is a link between Actos and the development of bladder cancer.

At least one province in Canada—Ontario—has moved Actos off the list of drugs that can be freely prescribed and onto a list that requires approval before prescription. Some experts in Canada say the drug should only be used in patients who have done well on it in the past.

Health Canada says the risk appears to be highest in patients who took the drug for the longest periods or at the highest doses. But, the agency does not rule out a risk of bladder cancer even in short-term Actos use. Health Canada recommends Actos not be used to treat patients with active bladder cancer, a history of bladder cancer or unexplained blood in their urine.

Lawsuits have been filed against Takeda Pharmaceuticals alleging Actos caused some patients to develop bladder cancer. The first lawsuits were reportedly filed in August 2011, with some experts predicting thousands of Actos bladder cancer lawsuits could be filed, according to The Washington Post (8/5/11).

Actos sales were suspended in Germany and France because of safety concerns. In 2011, the FDA issued its own warning about a possible link between Actos and bladder cancer, although sales of Actos in the US continue.

Actos became the top-selling diabetes medication after rival drug Avandia was shown to increase the risk of heart attack in patients. Use of Avandia was severely restricted after an FDA advisory panel meeting, although patients can still use Avandia under limited circumstances. Actos was thought to be safer than Avandia, but concerns about the risk of bladder cancer put a damper on the drug's sales.