A number of recent studies have suggested that the link between Actos (pioglitazone) and bladder cancer was much stronger than was indicated in prior clinical trials. The U.S. Food and Drug Administration (FDA) published a “Drug Safety Communication” nearly two years ago that suggested that, based on the duration of use and dosage prescribed, there could be as much as a 40 percent increased risk of developing Actos-induced bladder cancer.
In prior clinical trials, investigators found evidence the drug could cause bladder cancer. Despite this, most patients and even their doctors had no clue that Actos had been linked to causing bladder cancer. If they had known, obviously they would have likely opted for an alternative route of treatment for their diabetes. All the latest studies on Actos have continued to find strong evidence linking the drug to bladder cancer, including one which showed that Actos users had an 83 percent increased risk for bladder cancer.
What is Bladder Cancer?
With an estimated 74,000 people diagnosed just last year, bladder cancer is one of the most common types of cancer in the United States. This disease claims the lives of thousands of people on an annual basis, and health care experts believe that the number of bladder cancer cases will increase over the next decade. Given the number of people affected by this disease, there is a significant amount of cancer research looking into alternative methods of prevention and treatment for bladder cancer.
Some of the leading causes of bladder cancer include long-term smoking and chemical exposure. Further research has shown that this disease is more common among men than women, and it is diagnosed in more Caucasians than African-Americans. Unfortunately, this disease also has a relatively high rate of recurrence.
Three Studies Highlighting the Link to Bladder Cancer
In regard to Actos bladder cancer, there are three studies which are cited more often than not. One of these was an extensive decade-long study that was conducted by Kaiser Permanente in Northern California. This research was initiated in 2002 following results from preclinical trials which showed an increase in urinary bladder tumors among tested lab rats. While the final results are still being held, the five-year interim analysis of the data indicated a 40 percent increased risk for bladder cancer amongst patients that had been on Actos for more than a year. This formed the basis for the label requirements on Actos that were set in place by the FDA two years ago.
Even more people are familiar with the three year international study that was conducted by the French Medicines Agency. A team of scientists tracked 1.5 million patients from 2006 to 2009. They discovered that the patients who took the active ingredient in Actos, pioglitazone, had a significantly greater risk of developing bladder cancer. Their findings were obviously quite similar to those of the Kaiser Permanente study.
About two years ago, the French Medicines Agency announced that they were suspending the use of Actos. Germany made a similar declaration soon afterwards, except their suspension was applied only to new cases. Later that year, Takeda officially withdrew their diabetes drug from those European markets. The American Diabetes Association also published their own report detailing the adverse side effects that had been reported to the FDA in connection to Actos.
Risk of Bladder Cancer Linked to Length of Drug Use
The most recent study on Actos and bladder cancer was published exactly one year ago in the British Medical Journal. Clinical investigators had examined 115,727 patients, and they concluded that the use of Actos could increase their risk of bladder cancer by up to 83 percent! They also noted that the overall increase in risk was directly related to how long someone took this drug.
Many prescription drugs come with the risk of negative side effects. Whether or not one chooses to take this risk is up to a patient and his or her physician. However, Actos has proven to be a medication of which one should be especially wary.