In May 2014, the US Food and Drug Administration (FDA) approved vorapaxar (Zontivity; Merck), an oral antiplatelet agent, for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction or peripheral arterial disease.1 The FDA acted after a 10 to 1 vote in favor of approval in January 2014 by the Cardiovascular and Renal Drugs Advisory Committee; both of us were members of this committee, and one of us (M.J.K.) cast the negative vote. Physicians should understand the benefit-risk balance of vorapaxar: the important benefit is the drug’s potential role in clinical practice as part of a 3-drug antiplatelet regimen for secondary prevention of myocardial infarction and in peripheral artery disease; the serious risk is clinically significant bleeding, including intracranial hemorrhage.
Krantz MJ, Kaul S. Secondary Prevention of Cardiovascular Disease With VorapaxarA New Era of 3-Drug Antiplatelet Therapy?. JAMA Intern Med. 2015;175(1):9-10. doi:10.1001/jamainternmed.2014.5802