An investigation published by The BMJ today raises new concerns about the top-selling anti-clotting drug, rivaroxaban (Xarelto).
It questions the validity of a pivotal trial - known as the ROCKET-AF trial - that was used to gain approval for rivaroxaban from the US and European regulators.
The trial, published in the New England Journal of Medicine (NEJM) in 2011, compared rivaroxaban with the older anti-clotting drug warfarin for preventing strokes in patients with irregular heartbeat (atrial fibrillation).