FDA allows omega-3 medication to be marketed off-label

Abstract

Amarin’s icosapent ethyl (Vascepa) is FDA approved to treat extremely high triglyceride values of 500 mg/dL or above. Although physicians commonly prescribe the medication for offlabel use, the agreement would allow Amarin to market Vascepa to patients with high triglyceride levels of 200 mg/ dL to 499 mg/dL. “This is concerning to me because ef cacy has not yet been clearly established for this purpose,” said Joseph Saseen, PharmD, BCPS, BCACP, vice chair of the department of clinical pharmacy at University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences in Aurora.