ADE Risk and Study Concerns Halt FDA's Xarelto Expansion
Last week an FDA advisory panel decided six-to-four against expanding the use of the prescription anticoagulant Xarelto (rivaroxaban). The drug's manufacturer, Johnson & Johnson, was hoping to gain the FDA's approval for Xarelto's use in treating acute coronary syndrome, a potentially life-threatening condition where a clot reduces blood flow to the heart. The syndrome is commonly treated through the use aspirin or Plavix, another anticoagulant drug similar to Xarelto.
Even though preliminary data suggests that Xarelto could be effective, doubts about the 15,500-patient study's data integrity and possible drug-drug interactions between Xarelto and Plavix concerned the panel members. While the panel acknowledged that Xarelto would be effective at treating the syndrome, they were unconvinced that the potential benefits outweighed the increased risk of bleeding events or other adverse drug effects.
The FDA will take the advisory panel's decision into account and release their final decision by June 29th. It is expected that they will follow the panel's opinions.
This decision does not affect Xarelto's use in treating previously approved conditions such as atrial fibrillation.