Actos Increases Risk In Diabetes Patients

After becoming the best-selling diabetes drug worldwide in 2007, Actos has been banned in France and Germany. Since its release onto the market in 1999, studies have linked Actos to a 40 percent higher rate of occurrence for bladder cancer in patients who take the drug for an extended period. Consequently, France and Germany have ordered doctors to stop prescribing the drug due to the increased risk of developing bladder cancer. However, the European Medicines Agency, which regulates drugs in the European Union, has decided to perform a safety review, stating the drug may be safe in some instances. The French Medicines Agency also conducted a study which indicated that diabetes patients who use Actos have a 22 percent higher risk of developing bladder cancer than those who take other diabetes drugs. Actos has also been linked to increased incidence of heart disease, liver failure, bone fractures, and blindness.

Although Actos has been banned in France and Germany, the U.S. has been slow to limit sale of the drug. The FDA issued a drug-safety announcement stating that it will continually evaluate the findings of a study conducted by Takeda Pharmaceuticals, the makers of Actos, along with a French study that monitored 1.5 million diabetes patients. The French study found a “significantly significant increase” in the risk of developing bladder cancer in patients who were treated with Actos instead of other diabetes drugs. According to the FDA, it must first reach a general conclusion that there is a “reasonable probability” that the drug will cause death or serious negative consequences to one’s health. The FDA released a statement indicating that patients should consider the benefits of using Actos to control their blood sugar in light of the unknown risk of developing cancer.

While the FDA actively reviews the data from studies, it has issued advisories for those who might administer or take the drug. The drug’s label has also been updated to reflect that using Actos for a length of time longer than a year may be associated with a higher probability of developing bladder cancer. However, the FDA scaled back the advisory in May 2012 and now only requires that the warning be issued in a separate Medication Guide. Nevertheless, the FDA recommends that patients with active bladder cancer avoid Actos and that those with a history of bladder cancer carefully consider the risk of recurrence.