The inevitable has happened for Bayer's fast-selling anticoagulant blockbuster, Xarelto. Someone in the U.S. has filed a lawsuit over its safety concerns. In fact, a number of lawsuits have been filed, according to reports in a German newspaper.
Citing the Frankfurter Allgemeine Zeitung, Reuters reports that a company insider disclosed lawsuits have been filed over Xarelto in the U.S. where it is marketed by Johnson & Johnson's ($JNJ) Janssen unit, although so far fewer than 10. A Bayer spokesperson declined to comment on the report, saying only that Xarelto's safety profile since being launched in 2011 has been consistent with the results of clinical studies that involved more than 75,000 patients, Reuters said.
The ease of using new oral anticoagulants like Xarelto and Pradaxa from Boehringer Ingelheim have made them big sellers as they take over the market for the old standard warfarin, a drug that is difficult to dose and has safety issues as well. Xarelto generated sales of €949 million ($1.3 billion) last year and Bayer CEO Marijn Dekkers has said he expected sales could reach €3.5 billion. Already approved for 6 indications Bayer and J&J have been trying to get Xarelto approved for use in acute coronary syndrome (ACS) patients, a big market, but the FDA in February turned them down for the third time.
Still, Xarelto and Pradaxa are scarfing up market share and as they have, the number of people suffering from side effects has grown. German media reports last fall said that in the first 8 months of 2013 Bayer reported 968 side-effect reports to German regulators tied to Xarelto, including 72 deaths. That was up from the 750 reports of adverse reactions and 58 deaths in all of 2012.
Pradaxa was approved in 2010, a year ahead of Xarelto, so it has for the most part paved the way in the market. It already has racked up a significant number of lawsuits in the U.S. filed over alleged problems. Boehringer Ingelheim last month agreed to pay $650 million to settle about 4,000 lawsuits. The concerns over the number of adverse reaction reports generated by Pradaxa has prompted the FDA to take a closer look. Last month it announced that Pradaxa was safer than warfarin in most cases. It said that among new users, Pradaxa has a lower risk of clot-related strokes, bleeding in the brain and death than warfarin. However, the risk of major gastrointestinal bleeding was higher, while the MI risk of the two drugs was about the same.