This week, a consumer watchdog group known as Public Citizen issued a letter to the U.S. Food and Drug Administration regarding the stroke prevention drug, rivaroxaban (Xarelto). The group urged the FDA not to approve the drug for use in patients with atrial fibrillation because uncertainties still remain about the medication’s overall safety and effectiveness.

In its letter to the FDA, Public Citizen expressed concern over a recent discrepancy in opinion between an FDA advisory committee’s recommendation about the drug and a clinical review of the medication. In September, an FDA advisory committee recommended approval of rivaroxaban for stroke prevention in those with atrial fibrillation. However, clinical staff reviewers of the drug said that is should not be approved, citing more tests should be conducted to shed additional light on safety and efficacy issues.

Public Citizen also wrote, “Given the uncertainty surrounding the efficacy and safety of this drug, and the fact that there are already two existing therapies for the same indication, rivaroxaban should not be approved until appropriate clinical studies are performed.” The group also outlined concerns surrounding the phase III ROCKET-AF trial for the drug, citing ethical concerns relating to study protocol and conduct.

The drug, which is marketed by Johnson & Johnson and Bayer AG, is slated for final review by the FDA in early November. Xarelto is one of three new anti-blood clotting medications expected to replace warfarin, which has been on the market for decades.


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