The U.S. FDA (Food and Drug Administration) approved Zontivity or vorapaxar on May 8 followed by a recommendation for its safe use by the agency's advisory panel. The new medication reduces the risk of stroke, heart attack, death from cardiovascular diseases and need for medical procedures to restore blood flow to the patient's heart after a heart attack or artery blockages to the legs.
Zontivity is produced by Merck & Co., a pharmaceutical manufacturer in the U.S. After being delayed due to safety concerns over serious and even fatal bleeding in patients during clinical trials, the FDA approved it with 10-1 votes in favor of it.
Zontivity is the first protease-activated receptor-1 (PAR-1) antagonist. The new drug is an anti-platelet agent, used to deter the platelets from clumping together and forming a blood clot. By lessening the forming of blood clots, the drug lessens the risk of stroke and heart attack as well.
Around 19,000 Americans have a repeated heart-related event every year. Zontivity will be used to supplement a standard therapy prescribed to prevent a second event which is typically the clot preventer Plavix or aspirin.
Zontivity will decrease the risk of stroke, heart attack or death from a cardiovascular disease of people who have clogged arteries in their legs (peripheral arterial disease) or have already had a heart attack. According to the study that backed the approval of Zontivity, it decreased the risk from 9.5 percent to 7.9 over the course of three years.
Patients who have had previous heart attacks are still at an increased risk of repeated heart attack, death or stroke even while using anti-clogging drugs currently available in the market. "The approval of vorapaxar is a welcome decision as it fills an unmet need and can reduce the risk of the above events further," Dr. Sripal Bangalore, associate professor of cardiology at NYU Langone Medical Center, New York City said.
However, Zontivity increased the risk of bleeding just like other blood-clot preventers. It hinders blood platelets from forming a cluster. The FDA recommends patients who have already suffered from traumatic head injuries and stroke to avoid this new drug.
Health care professionals must inform their patients that they may bruise or bleed more easily while taking this medication. Those who experience unanticipated, excessive and prolonged bleeding or see blood in their urine or stool should report it immediately to their health care professional.
