European Medicines Agency (EMA) urges new warnings about possible link to bladder cancer
(Reuters) – Takeda Pharmaceutical’s diabetes pill Actos should carry new warnings about its possible link to bladder cancer, Europe’s drug regulator said on Thursday, following a safety review of the medicine.
The Japanese company’s medicine remains a valid treatment option for certain patients with type 2 diabetes, despite the small increased risk of bladder cancer, the European Medicines Agency (EMA) said.
The EMA said the risk could be reduced by appropriate patient selection and exclusion, including a requirement for periodic review of the efficacy and safety of the individual patient’s treatment.
Last month both France and Germany suspended use of Actos and Competact — which combines Actos and an older drug called metformin — after an official French study found a link to a slightly increased risk of bladder cancer.
Other European countries, however, decided to hold fire pending a decision by the EMA.
Takeda said it would update its physician and patient information for Actos, known generically as pioglitazone, once the new recommendations from the EMA were endorsed by the European Commission.
“Takeda is confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes, and remains committed to pioglitazone and pioglitazone-containing medications,” the company said in a statement.
The U.S. Food and Drug Administration said recently it was adding information to the drug’s label about the potential risk of bladder cancer from long-term use, while keeping the product on the market for the time being.
The FDA initiated a safety review of Actos last September, while its European counterpart started a probe in March.
Actos had global sales of 387.9 billion yen ($4.8 billion) in the year ended March 31, accounting for 27 percent of Takeda’s revenue.
It belongs to the same drug class as GlaxoSmithKline’s Avandia, which was pulled from the market in Europe and had severe restrictions imposed on its use in the United States last September after being linked to heart risks.
GSK’s drug has not been associated with bladder cancer.
Actos was approved for use in Europe in 2000 but its potential bladder cancer risk, seen in tests of male rats, has long been a topic of discussion. (Reporting by Ben Hirschler; Editing by Hans-Juergen Peters and Will Waterman)