Link Between Actos and Bladder Cancer Being Reviewed in Canada

Canadian health officials are launching their own review of the possible risk of bladder cancer from Actos, after warnings were issued last week in the United States and several European countries decided to suspend the medication earlier this month.  

Health Canada announced on June 17 that it was reviewing the status of Takeda Pharmaceutical’s Actos due to studies that suggest an increased bladder cancer risk.

The review comes days after the FDA issued an drug safety communication about the link between Actos and bladder cancer, requiring new information be added to the warning label for the popular type 2 diabetes drug. 

Earlier this month, an Actos recall was issued in France and Germany, after a review of public insurance data identified an increased incidence of bladder cancer with Actos use. Other European countries are also reviewing the risks associated with Actos, including a hearing scheduled for today by the European Medicines Agency. 

Canadian officials said they will take any appropriate action if they determine that the studies represent new safety information that affects the potential risk of the drug. Currently, Health Canada considers the benefits of Actos to outweigh the risks when used as directed, and recommends Canadian citizens talk to their pharmacist of physician if they have any questions about the drug’s safety. 

In the United States, the FDA has concluded that new warnings should be added to the drug indicating that use of Actos for more than one year may increase a patient’s chances of being diagnosed with bladder cancer. The warnings will also be added to other medications that contain pioglitazone, the active ingredient in Actos, including Actoplus Met, ActoplusMet XR and Duetact.

The FDA began reviewing the possible connection between bladder cancer and Actos in September 2010, after preliminary data from an on-going 10 year study suggested that there may be an increased risk the longer the drug is taken.

Actos (pioglitazone) was approved in July 1999, and is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.

Sales have increased in recent years, after a number of studies have suggested that Actos may be safer than its primary competitor, Avandia, which has been linked to an increased risk of heart attacks and deaths.

Last month, a study by Italian researchers found a disproportionate number of Actos bladder cancer reports in the FDA’s own Adverse Event Reporting System Records. However, that study did not establish a causal effect between Actos and bladder cancer.

Since information about the potential bladder cancer risk associated with Actos first surfaced last year, a number of former users diagnosed with bladder cancer are considering pursuing an Actos lawsuit against Takeda Pharmaceuticals for failing to fully research the side effects of the medication or adequately warn about the potential risk of bladder cancer.