Bladder Cancer Risk Leads to Actos Limitations in Ontario

The Canadian province of Ontario is limiting patient access to Actos, due to the risk of bladder cancer associated with long-term use of the diabetes drug. 

The Ontario Public Drug (OPD) Program has announced that it is removing Actos from its regular list of approved drugs, which will require patients go through special steps to get it.

The decision comes just days after Health Canada issued an Actos bladder cancer warning, indicating that the longer someone takes the drug and the higher the dose taken, the greater the risk of developing bladder cancer.

Actos has been added to the OPD’s Exceptional Access Program (EAP), meaning that doctors cannot prescribe it at will. Instead, patients will have to submit a request for the drug, explaining to EAP why use is necessary. The move went into effect on April 24.

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.

Bladder cancer concerns with Actos have resulted in stronger label warnings in the United States and European Union as well, and an Actos recall was issued last summer in France after a review of insurance data found an increased rate of bladder cancer among users of the drug.

Several hundred people throughout the United States have already filed an Actos lawsuit against Takeda Pharmaceuticals after developing bladder cancer while on the drug. The complaints involve similar allegations that Takeda failed to provide adequate warnings about the bladder cancer risk from side effects of Actos.

In the U.S. federal court system, the 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.