The U.S. Food and Drug Administration (FDA) has approved Zontivity (vorapaxar) tablets to lower the risk of heart attack and stroke.
Zontivity is an anti-platelent agent designed to prevent blood clotting. It helps keep platelets from clumping together, which reduces the likelihood of a heart attack and stroke. It also keeps procedures such as those for heart blood flow restoration in patients who have had previous heart attacks or blocked leg arteries at bay.
The drug is the first in a new class of drugs called protease-activated receptor-1 (PAR-1) antagonist. To study it, the FDA conducted a clinical trial that involved over 25,000 people. It was found that when Zontivity is added to other anti-platelet drugs like aspirin and clopidogrel, it brought down the rate of heart attack, stroke, and cardiovascular death, as well was urgent procedures to increase blood flow to the heart (coronary revascularization).
The Director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research Ellis Unger, M.D., said in a news release. "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."
The FDA warns that due to Zontivity's anti-blood-clotting abilities, the risk of bleeding is greater. People who have had a previous stroke, transient ischemic attack (TIA), or bleeding in the head cannot use it because of the high risk of bleeding.
Health professionals are also cautioned to inform patients of bruising and bleeding more easily when taking the drug. In addition, patients have to watch for bleeding and signs of blood in their stool and urine.
To address these risks, Zontivity will be packaged with an FDA-approved patient Medication Guide with usage instructions and other safety information. It will also come with a boxed warning.
