Germany became the second European country to suspend sales of Takeda Pharmaceuticals' Actos drug, the company's top seller. Just after France announced that it would block sales of Actos because of research suggesting an association between long-term use and bladder cancer, Germany joined in. The rest of Europe is waiting for authorities to finish their analysis of the data.
France's move came in the wake of an official study, which found that Actos and its sister drug Competact appeared to slightly boost the risk of bladder cancer. After reviewing the French study, Reuters reports, Germany's Federal Institute for Drugs and Medical Devices announced that while patients currently using the drug should continue until they see their doctors, no new scrips should be written.
The European Medicines Agency started its review of Actos safety in March, after FDA launched its own analysis last fall. European experts are slated to discuss the latest data at a meeting beginning June 20, the news service reports. Meanwhile, Japanese authorities say they have no plans to recall Actos, which accounted for 27 percent of Takeda's revenues, with global sales of $4.8 billion.
Together with last year's European withdrawal of GlaxoSmithKline's Avandia, the moves against Actos leave France and Germany without diabetes drugs in that class, known as glitazones. Avandia, of course, was pulled because of links with cardiac problems, and Actos was seen as a safer alternative.