Canada Becomes Latest Nation to Warn of Actos Bladder Cancer Risks

Last week Health Canada, the nation’s public health department, officially warned diabetes patients of the increased risk of bladder cancer that is possible for those taking Actos.  The labeling on this medication in Canada will also receive changes to reflect that cancer warning. 

Actos (pioglitazone hydrochloride) is authorized for use by Canadian patients with Type 2 diabetes who cannot control their blood sugar with just diet and exercise.  However, the new warning cites the five-year interim analysis of an ongoing 10-year study in patients taking this medication which suggests an increased risk of bladder cancer for those who take it longer than 12 months.    

This safety communication from the Canadian health department comes close to a year after the U.S. Food and Drug Administration (FDA) made a similar announcement last June.  The FDA announcement also cited preliminary results from the 10-year study on the medication, as well as an epidemiological study conducted in France.  The drug has since been pulled from the shelves in both France and Germany.                  

The Health Canada safety alert also warns that this medication should not be used by patients who have or have had bladder cancer, or those who have blood or red color in their urine.  Furthermore, patients taking this drug who begin to have red-colored urine, feel an increased need to urinate, or have pain while urinating are instructed to seek medical attention, as these may be the symptoms of bladder cancer.   

The announcement also notes the bladder cancer risk factors doctors need to evaluate for each patient before they start this medication.  These risks include age, smoking history, family bladder cancer history, workplace chemical exposure, cancer treatments, and radiation therapy.

In the U.S., the FDA’s warnings about the use of Actos have led to a string of lawsuits against the drug’s manufacturer, Takeda.  In fact, a Bloomberg Businessweek article from last month said that Takeda may face as many as 10,000 claims following last year’s FDA safety announcement. 

Bloomberg reports that those claims, which were consolidated in December, allege the manufacturer “withheld information about the risk and failed to provide adequate warnings.”  The FDA notes that from January to October 2010 the medication saw widespread use, as about “2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.”