TOKYO/LONDON Germany has joined France in suspending the use of Takeda Pharmaceutical's Actos diabetes drug, due to worries about a possible link to cancer.
The move is a blow for the Japanese firm, whose best-selling drug has worldwide sales of close to $5 billion, though the financial impact will be limited by the fact the drug faces looming generic competition in key markets.
Shares in Takeda fell 2.9 percent on Friday, against a 0.5 percent rise in the benchmark Nikkei average.
On Thursday, France's drug safety authority suspended use of both Actos and Competact -- which combines Actos and an older drug called metformin -- after an official French study found they appeared to slightly raise the risk of bladder cancer.
Germany's Federal Institute for Drugs and Medical Devices (BfArM) said it had decided to follow suit after receiving results of the study by France's national health insurance body, which tracked patients on diabetes drugs between 2006 and 2009.
"BfArM recommends the suspension of approval of pioglitazone (Actos) until further clarification. Doctors should not put new patients on pioglitazone," the German regulator said in a statement.
A Takeda spokesman had earlier said the German authorities had informed the company of their intentions.
Both the French and German regulators said patients currently being prescribed Actos should continue to take their medicines until they could consult with their doctors, since they could be in danger if they stopped treatment.
Other European countries are holding fire on Actos and a spokeswoman for the European Medicines Agency said it was not aware of any other national authorities taking action.
The European agency, based in London, initiated a review into the safety of Actos in March and its experts will discuss the latest data on the drug at a June 20-23 meeting.
Britain's drugs regulator said it was not recommending any changes to Actos use while the European review was going on and the Danish medicines agency also told Reuters it had no plans to "go it alone" on suspending the drug.
NO ACTION FROM FDA
In the United States, the FDA initiated a safety review of Actos last September, but Takeda said U.S. regulators had not signaled any intention to request a recall.
Japan's health ministry also said the body had no plans for a recall of the blockbuster product, which had global sales of 387.9 billion yen ($4.8 billion) in the year ended on March 31, accounting for 27 percent of Takeda's revenues.
Actos 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.
Interim results from trials being conducted by U.S. health insurer Kaiser Permanente, one of which began in 2003 and is slated to last 10 years, have so far not confirmed a clear association between Actos and bladder cancer.
(Additional reporting by Frank Siebelt in Frankfurt and Mette Fraende in Copenhagen; Editing by Chris Gallagher, Joseph Radford and Sophie Walker)