Cancer Risk Warning for Takeda’s Actos as per EMA Recommendation

Earlier on Thursday, the European Medicines Agency recommended adding a warning label regarding a “small increased risk of bladder cancer” to Takeda’s Actos (pioglitazone). The benefits of the drug were found to prevail over its risks only “in a limited population” of type 2 diabetes patients, reported the agency that conducted a review of the drug’s active ingredient.

According to the EMA, “appropriate patient selection and exclusion” including regular reviews of individual patient benefits of the drug could significantly reduce cancer risk. During a meta-analysis of randomized studies, the agency noted that compared to 7 out of 10,212 patients (0.07%) patients who did not receive the drug, 19 out of 12,506 patients (0.15%) who were administered Actos developed bladder cancer.

Not only had the FDA issued a similar warning for the product in June but also the French and German regulatory agencies had suspended use of the drug earlier that month. Between 2006 and 2009, results of a French study conducted to track patients taking Actos revealed that the product carried somewhat of an increased risk of bladder cancer.

In the last fiscal year, Actos generated 387.9 billion yen ($4.9 billion) worth of sales.