The European Medicines Agency recommended Thursday that a warning be
added to the label of Takeda's Actos (pioglitazone) regarding a "small
increased risk of bladder cancer." The agency said that after conducting
a review of the drug's active ingredient, its benefits outweigh its
risks only "in a limited population" of people with type 2 diabetes.
The risk could be reduced by "appropriate patient selection and
exclusion," including regular reviews of how well the diabetes drug is
working for individual patients, according to the EMA. The agency noted
that in a meta-analysis of randomised studies, 19 out of 12 506
patients, or 0.15 percent, who took Actos developed bladder cancer,
compared with seven out of 10 212 patients, or 0.07 percent, who didn't
receive the drug.
In June, the FDA issued a similar warning for the product, while earlier that month regulators in France and Germany
suspended use of the drug. The results of a French study that followed
patients taking Actos between 2006 and 2009 suggested that the product
carried a slightly increased risk of bladder cancer.
Actos generated sales of 387.9 billion yen ($4.9 billion) in the last fiscal year.