The head office of Japanese pharmaceutical company Takeda Pharmaceutical Co., Ltd. is seen in Tokyo July 9, 2009.
Credit: Reuters/Stringer
TOKYO | Fri Jun 10, 2011 11:43am BST
TOKYO
On Thursday, France's drug safety authority suspended use of both Actos and CoTmpetact -- which combines Actos and an older drug called metformin -- saying an official study had found they appeared to slightly raise the risk of bladder cancer.
The French Medicines Agency have told doctors to stop prescribing the two drugs, but said people who use them should continue to do so until they could consult their doctors.
A Japan-based Takeda spokesman said German authorities informed them they will take the same measures.
The European Medicines Agency, based in London, said earlier it was reviewing all relevant data about the safety of Actos and the possibility of a link to bladder cancer, but was not recommending any changes in use in the meantime.
In the United States, the FDA initiated a safety review of Actos and its potential to increase the risk of bladder cancer last September, but Takeda said earlier that U.S. regulators had not signaled any intention to request a recall.
Earlier on Friday, an official at Japan's health ministry said the body also has 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.
News of the suspension caused Takeda's shares to fall 2.9 percent and settle at 3,665 yen on Friday, against a 0.5 percent rise in the benchmark Nikkei average.
($1 = 80.305 Japanese Yen)
(Reporting by James Topham; Editing by Chris Gallagher and Joseph Radford)
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