FRANKFURT (Reuters) - Bayer faces a growing number of reports of suspected undesirable side-effects from its stroke prevention pill Xarelto, German magazine Der Spiegel reported, citing data from a federal authority.
There was a total of 968 cases of suspected undesirable side-effects related to Xarelto in the first eights months of 2013, including 72 cases of death, the magazine reported, citing Germany’s Federal Institute for Drugs and Medical Devices (BfArM).
This compares to 750 cases of side-effects, including 58 cases of death, for the whole of 2012, the magazine said. BfArM said there was no clear proof of a correlation between the drug and side effects, the report said.
Jointly developed with U.S. peer Johnson & Johnson, Xarelto is one of Bayer’s most important new drugs, expected to earn annual peak sales of more than 2 billion euros ($2.63 billion).
In the second quarter, Bayer made 219 million euros in sales from the anti-clotting pill, more than three times as much as during the same period last year.
When asked about the report on Sunday, a spokesman for Bayer said Xarelto’s risk-benefit profile was still intact.
BfArM was not immediately available for comment.
Reporting by Frank Siebelt, Hans Seidenstuecker and Christoph Steitz, editing by William Hardy