FDA approves heart attack drug
The Food and Drug Administration approved Zontivity (vorapaxar) tablets last week. The medication is meant to reduce the risk of heart attack, stroke, cardiovascular death or a need to operate to restore blood flow for patients with a previous heart attack or blockages in the arteries.
Zontivity is the first in a new class of drug called a protease-activated receptor-1 (PAR-1) antagonist. It is an anti-platelet agent. Bleeding is the most commonly reported adverse reaction in people taking Zontivity.
The drug cannot be used by people who have had a stroke, transient ischemic attack (TIA), or bleeding in the head because the risk of bleeding is too high. Healthcare professionals should tell patients that they may bleed and bruise more easily when taking Zontivity, but clinical trials showed the drug reduced the risk of death from a heart attack or stroke, officials said.
“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.