* U.S. regulator says Actos drug can raise risk of bladder
* Says warning should be added to label
* France, Germany last week suspended sales of the drug
* Takeda shares down 1.1 percent vs 0.9 percent fall in
(Adds analyst comment, background, updates share price)
TOKYO, Jun 16 Japan's Takeda Pharmaceutical Co
shares fell after U.S. regulators said Takeda's Actos
diabetes drug can raise the risk of bladder cancer if used for
more than a year and that a warning should be added to the
top-selling drug's packaging.
Last week, France and Germany suspended sales of Actos over
similar fears, and attention had shifted to the U.S. Food and
Drug Administration, which oversees the biggest market for
"The FDA's action is extremely mild, when compared with the
measures taken by France or Germany," said Jefferies analyst
Naomi Kumagai. "The FDA is not taking Actos off the shelves or
asking doctors to stop prescribing it. It is merely telling
professionals to inform patients of the risk-benefit balance."
"This on its own will not have an immediate impact on sales.
Still, it is certainly not a positive," she said.
Takeda's shares were down 1.1 percent at 3,670 yen after
flirting with a three-month low, against the Nikkei's
0.9 percent fall.
The FDA, which is conducting an ongoing 10-year study of
Actos, said that patients who had the highest cumulative dose of
the drug had an increased risk of bladder cancer, but that Actos
did not lead to an increased risk of bladder cancer in the study
Takeda is set to lose patent protection for Actos in the
U.S. market soon, and will be exposed to competition from
generic pills next summer. It said in a statement that it would
add the appropriate warnings.
Actos, which has captured close to $5 billion in worldwide
sales for Takeda, is also under review by the European Medicines
Agency, based in London. Its decision could have an impact on
the FDA, analysts said.
Actos competes with Merck and Co's Januvia and
Janumet, which uses a different mechanism. Actos belongs to the
same drug class as GlaxoSmithCline's Avandia, which was
pulled from the European market and had its use restricted in
the United States last September, after studies linked it to
(Reporting by Mayumi Negishi; Editing by Joseph Radford)