Actos Warning Over Bladder Cancer Risk Added in Canada

Canadian health officials have issued new warnings that the diabetes drug Actos may increase the risk of bladder cancer. 

Health Canada issued the Actos warnings on Thursday, following a safety review launched last summer, when the FDA made similar warnings for users in the United States.

The Canadian regulatory agency indicated that the risk of bladder cancer from Actos appears to be dose-specific, meaning there may be an increased risk of cancer the longer someone took the drug and the higher the doses taken.

The warnings over bladder cancer will be added to all Actos drug labels in Canada. Health Canada recommended that Actos not be given to patients with active bladder cancer, a history of bladder cancer problems or blood in their urine.

Actos (pioglitazone) was developed by Takeda Pharmaceuticals and approved in the United States to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. The medication has grown in popularity in recent years, generating $4.3 billion in sales last year.

FDA officials began reviewing the potential risk of bladder cancer problems with Actos use in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug.

Both France and Germany instituted an Actos recall as a result of the risks associated with the medication, and the drug has seen increased label warnings in the United States and across the rest of the European Union.

The Canadian warnings come as the number of Actos lawsuits continues to increase in the United States, where dozens of complaints have been filed in courts throughout the country and new cases continue to be brought each week.

All of the complaints involve similar allegations that Takeda Pharmaceuticals, the manufacturer of the drug, failed to provide adequate Actos warnings for bladder cancer and actively attempted to conceal the risk from consumers and the medical community.

The federal Actos litigation has been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized in the U.S. District Court for the Western District of Louisiana.

In Canada, an Actos class action lawsuit was filed in December on behalf of all users in the country diagnosed with bladder cancer after using Actos. The complaint was filed by the estate of a Toronto woman who died in 2011 from bladder cancer after taking Actos for treatment of type 2 diabetes.