Earlier this year, Xarelto was approved for use as an anti-coagulant following knee or hip replacement surgery.
In September scientists at the FDA recommended that the regulatory agency restrict use of the companies’ blood thinner Xarelto over concerns that users would be at greater risk of suffering a stroke.
Analysts have predicted that Xarelto would generate sales of at least $1 billion as a more convenient substitute for warfarin, a stroke prevention drug that has been used for seven decades.U.S. pharmacies filled 32 million prescriptions for warfarin in 2010, according to data tracker IMS Health.
As part of the drug’s labeling, Xarelto has a boxed warning that people using the drug should not discontinue it before talking with their health care professional, as discontinuing the drug can increase the risk of stroke, according to a press release from the FDA.