Actos and cancer have been associated in recent injury reports, which spurred the FDA to add the risk of bladder cancer to the drug’s warning label in 2011. However, the medical community has been concerned over the alleged correlation between Actos and cancer since soon after the medication’s release in 1999.

The FDA recently warned the public against a potential Actos and cancer correlation in 2016, stating that the diabetes medication could increase the risk of bladder cancer.

Actos (pioglitazone) is a type-2 diabetes medication that lowers blood sugar levels by decreasing the insulin resistance and the amount of glucose made in the liver. This allows the patient to process excess blood sugar levels more efficiently and can help avoid diabetic ketoacidosis.

The recent association between Actos and cancer has left many patients and prescribing physicians wary. The FDA initially stated that the risk of bladder cancer increases if the patient takes Actos for over a year, based on the provisional results of a 10-year study. This study examined the records of type-2 diabetes patients in the database of Kaiser Permanente in northern California, which indicated a potential link between Actos and cancer.

The 2011 label revision suggested that physicians should not prescribe Actos to patients with pre-existing bladder cancer, and they consider alternative treatments with patients who have a history of bladder cancer.

Overview of Actos and Cancer Correlation

The provisional study results were analyzed at the five-year mark of a 10-year Actos study. Research showed that patients faced an increased risk of bladder cancer if they were exposed to high doses of the medication. Other inquiries found that the longer the duration of the Actos prescription, the higher likelihood of bladder cancer.

One of these studies was published in 2015 in the Journal of the American Medical Association, which analyzed the entire 10-year study from the Kaiser database but could reportedly not find an increased bladder risk in the interim results. However, an earlier study published in BMJ found a 63 percent increased risk of bladder cancer and that the risk increases with longer prescription periods and larger doses.

The results of the studies spurred the FDA to make a recent announcement regarding Actos and cancer, stating that the medication “may be associated with an increased risk in urinary bladder cancer, and we have updated the drug labels to include information about these additional studies.”

In addition to these studies, the medical community is currently evaluating the risk-benefit calculation for Actos. According to a study published in February 2016 in the New England Journal of Medicine.

The study found that Actos lowers the risk for recurrent stroke or myocardial infarction in patients with insulin resistance, but also increased the chances of weight gain, edema, and bone fractures requiring hospitalization or surgery.

According to some patients, manufacturer Takeda Pharmaceuticals allegedly knew that there was a potential risk between Actos and cancer, but allegedly failed to warn patients against the bladder cancer risk. This spurred serious litigation action against the pharmaceutical company from patients who allegedly developed bladder cancer due to Actos.