German regulator sees no new risks from Bayer's Xarelto

FRANKFURT, Sept 9 Mon Sep 9, 2013 8:39am EDT

FRANKFURT, Sept 9 (Reuters) - 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 Monday.

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 Strauss.

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 billion).

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.

A couple walks along the rough surf during sunset at Oahu's North Shore, December 26, 2013. REUTERS/Kevin Lamarque

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