ACTOS linked to bladder cancer – again!

by Jim Orr

A recently published study found that the diabetes drug Actos can double the risk of getting bladder cancer. The FDA  warned in June 2011 that taking Actos for at least a year increased the risk of bladder cancer by at least 40%, and ordered the drug’s manufacturer, Takeda Pharmaceutical North America, to note the risk on the drug’s label.

The generic name for Actos is pioglitazone.  Although Actos is intended to be taken over the long term, this new study suggests that people who use the drug for more than two years have almost double the risk of developing bladder cancer than people who have not taken the drug.

The latest study was done by researchers from McGill University and Montreal’s Jewish General Hospital. It was published May 31, 2012 in the journal BMJ, formerly known as the British Medical Journal.  The researchers found that 470 patients were diagnosed with bladder cancer in the average 4.6 years of follow-up, a rate of 89 cases per 100,000 person-years. They compared that to the rate of bladder cancer in the general U.K. population over 65 years of age: 73 per 100,000 person-years.

Thus, they found that if a patient had ever taken pioglitazone, the patient was at an 83% increased risk of developing bladder cancer, i.e., 74 cases per 100,000 person-years.  The more exposure to the drug, the greater the risk: a rate of 88 cases per 100,000 person-years for those who had taken the drug for at least two years, and 137 per 100,000 cases for patients who had taken a cumulative total of at least 28,000 milligrams of the drug.

Dr. David Juurlink, head of the division of clinical pharmacology at the University of Toronto, has said the Montreal study “leaves little doubt that pioglitazone is a potential risk factor for bladder cancer” and “adds fuel to the argument that this is a class of drugs that people should simply not be prescribing — doctors should simply not be prescribing.”

Heygood, Orr & Pearson is pursuing Actos cases on behalf of clients and will be involved closely with the Actos MDL and other Actos bladder cancer litigation matters, so you can expect to find more information here.  Of course, feel free to contact us if you have any questions about Actos.