“In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death. In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5 percent to 7.9 percent over a 3-year period – about 0.5 percent per year,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.
As in other drugs that inhibit blood clotting, bleeding is the most commonly reported adverse reaction. The drug's label information includes a Boxed Warning to alert health care professionals about this risk. Zontivity must not be used in people who have had a stroke, transient ischemic attack (TIA), or bleeding in the head, because the risk of bleeding in the head is too great.
 FDA Press Release, "FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients," May 8, 2014.