FDA approves clot-busting vorapaxar

FDA approved vorapaxar (Zontivity, Merck Sharp & Dohme Corp., a subsidiary of Merck) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.

Vorapaxar is the first in a new drug class, called a protease-activated receptor-1 (PAR-1) antagonist. It is an antiplatelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, vorapaxar decreases the risk of heart attack and stroke.

In a clinical trial with more than 25,000 participants vorapaxar, added to other antiplatelet agents (generally aspirin and clopidogrel), reduced the rate of a combined end point of heart attack, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart when compared to placebo.

“Stroke reduction is a prevailing health concern and the approval of [vorapaxar] provides another medication that will be available in the arsenal to reduce the incidence of stroke among Americans,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

Vorapaxar increases the risk of bleeding, including life-threatening and fatal bleeding, just as other drugs that inhibit blood clotting do. Bleeding is the most commonly reported adverse reaction in people taking vorapaxar. The drug comes with a Boxed Warning to alert healthcare professionals about this risk.

Vorapaxar 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.

Patients should be informed that they may bleed and bruise more easily when taking vorapaxar. They should report any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine. Vorapaxar will come with an FDA-approved patient Medication Guide.