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Federal drug reviewers are investigating whether the side effects of Actos, a diabetes drug that is part of the same class of medications as Avandia, may be linked to an increased risk of bladder cancer.
On Friday, the FDA announced that it has launched a safety review of Takeda Pharmaceutical’s Actos after data from an ongoing study suggested that users of the medication may have an increased risk of cancer the longer they took the drug. While the FDA has not concluded that Actos is linked to bladder cancer, they are taking a closer look at the drug.
The data came from an ongoing 10-year study of Actos by Takeda Pharmaceuticals. The company sent its data to FDA at the five year mark. Concerns over Actos first developed when it was discovered that rats given the drug had a slightly higher rate of bladder tumors.
The five-year data was a cohort study of 193,099 patients with diabetes. The initial results indicated that there was no statistically significant association between Actos and bladder cancer. However, when researchers factored in the duration the patients had been taking the drug, they found that the risk increased the longer patients were on Actos. After 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance. They also found increased bladder cancer risk in patients with high cumulative exposure to Actos.
Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year. Sales have increased in recent years since a number of studies have suggested that Actos was safer than its competitor, Avandia, which has been linked to an increased risk of heart attacks and deaths. Some experts and even federal regulators have called for an Avandia recall, which would likely lead to even greater use of Actos to treat diabetes.
The FDA cautioned that it has made no decision on the drug yet, and advised healthcare professionals to continue to follow label recommendations when prescribing Actos. The FDA also advised patients to keep taking the drug, and to talk to their doctor if they were concerned about Actos bladder cancer.