Sales of Xarelto have topped $1 billion year-to-date, despite growing concerns that the anticoagulant could cause severe side effects. The blood thinner, manufactured in tandem by Johnson & Johnson and Bayer Pharmaceuticals, was approved by the U.S. Food and Drug Administration in 2011, though the FDA has now requested more research from the companies.
Xarelto is one of the first new blood thinner drugs since warfarin, but patients have already exhibited similar blood thinner side effects, such as excessive bleeding, pulmonary embolism and internal hemorrhaging. The FDA denied expanding use of Xarelto and ordered more clinical studies of the drug as patients have come forward with side effects.
Xarelto side effects could affect sales of the drug moving forward. Nearly 2,000 Xarelto adverse events cases have been reported since the drug was approved, including 891 cases of hospitalization and 183 deaths.