FRANKFURT, Sept 9 The number of reported side
effects linked to Bayer's stroke prevention pill
Xarelto is below worrisome levels, a German drugs regulator
said, responding to a media report highlighting risks from
taking the blood thinning drug.
"There is no new risk situation," a spokesman for Germany's
Federal Institute for Drugs and Medical Devices (BfArM) said on
German magazine Der Spiegel reported over the weekend that
Bayer faced a growing number of reports of bleeding in patients
taking Xarelto, citing BfArM figures.
Bayer shares had declined 1.7 percent by 1208 GMT, while
Germany's blue-chip index DAX was little changed.
"Xarelto is a major drug hopeful for Bayer and it's not good
if a shadow is cast over it," said NordLB-analyst Thorsten
Bayer won regulatory approval in Europe for the drug's main
use, preventing strokes in patients suffering from a common form
of irregular heart beat, in December 2011.
There were 968 cases of suspected undesirable side-effects
related to Xarelto in the first eight months of 2013, including
72 deaths, the magazine reported.
BfArM said that, while the figures were within a range that
was to be expected, the regulator would continue to monitor
reported side effects.
A spokesman for Bayer said Xarelto's risk-benefit profile
was still intact.
Jointly developed with U.S. peer Johnson & Johnson,
Xarelto is one of Bayer's most important new drugs, expected to
yield annual peak sales of more than 2 billion euros ($2.63
The stroke preventer, which is also used to treat and
prevent deep vein thrombosis and pulmonary embolisms, competes
with Eliquis, sold by Pfizer and Bristol-Myers Squibb
, and with Boehringer Ingelheim's Pradaxa.