European officials are taking a cautious approach to evaluating Takeda Pharmaceutical's diabetes drug Actos. In the wake of suspensions in France and Germany--and new warnings from U.S. regulators--the EU's drug watchdogs had been scheduled to decide this week whether potential links to bladder cancer warranted action. But they decided to wait until July, saying there were "numerous issues that needed to be resolved."
For months, regulators have been looking at Actos. And that scrutiny intensified earlier this month, thanks to new data on potential links between long-term use of Actos and a higher risk of developing bladder cancer. A French study found new evidence of a connection between Actos use and bladder cancer, indicating that longer use of the drug slightly boosted the risk of developing the disease.
In announcing that study, French officials also said they would suspend use of the drug for now. German regulators quickly followed suit. Then, several days later, the FDA issued its verdict. The drug's label would get new information about the potential risk of bladder cancer with long-term use. Now, European countries who've been waiting to move until the European Medicines Agency delivered its opinion will have to wait until next month.
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