F.D.A. Panel Votes Against Expanding Use of an Anticoagulant
A federal advisory panel narrowly recommended against expanding the use of the Johnson & Johnson drug Xarelto on Wednesday, saying concerns over dangerous bleeding outweighed evidence that the drug helped reduce the risk of blood clots in patients with serious heart problems.
Xarelto is an anticoagulant drug that was approved last year to prevent blood clots in patients undergoing knee or hip replacement surgery and for people with a common form of heart arrhythmia called atrial fibrillation. Janssen, Johnson & Johnson’s pharmaceutical unit, is asking the Food and Drug Administration to allow the drug to also be used in patients with a condition called acute coronary syndrome in addition to the common treatment of aspirin plus clopidogrel, or Plavix.
Six members of the panel voted against approval, four voted for it and one abstained. The agency often, but not always, follows the advice of its outside experts. An F.D.A. staff reviewer had recommended that the panel approve the new use, saying that it significantly reduced the risk of cardiovascular death.
Several members expressed concern about the idea of adding a third drug to the two that are already the standard, aspirin and clopidogrel, and said the benefits of doing so did not outweigh the risks. Members of the panel also expressed concern that more than 15 percent of the study’s participants dropped out, calling into question the quality of the data.
“We really want to have very compelling evidence” that the drug helps patients, said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, who voted no.
He said that evidence of increased bleeding should not be taken lightly, and that when the bleeding was in the brain it could lead to irrevocable damage, a complication that he said some considered worse than death.