Reporting on Adverse Clinical Events

Abstract

Over a 6-month period, 36 people reported episodes of bleeding associated with the use of a falsified dietary supplement between April and July 2017. Based on an investigation conducted by the Public Health Department in Antioquia, Colombia, the supplement (Vitacerebrina) was identified as being the associated product, which contained warfarin, a nondeclared prescription anticoagulant ingredient on the label. The mean age of the case patients was 52.3 years (range: 15-8 years). Approximately one third of the patients were younger than 18 years of age. The majority were female (66.7%), with three quarters of them taking the supplement for 9 to 30 days. The most common symptoms were ecchymosis, hematuria, abdominal pain, and gingivorrhagia. All patients were hospitalized. On hospitalization, the majority (81%) had elevated coagulation tests (international normalized ratio). The median duration of the hospital stay was 6 days (range: 2-11 days). Most patients (67%) received either intravenous or oral vitamin K as treatment. No patient deaths were recorded. All patients recovered and were discharged in good clinical condition. The authors concluded that these patients developed hemorrhagic illness related to the inadvertent administration of warfarin, which was not listed as an ingredient in a falsified dietary supplement. Dietary Supplement [“Vitacerebrina”] Pena-Acevedo L et al (L Pena-Acevedo, LIME, IPS Universitaria Sede Prado, Cra. 51A # 62-42, 2nd Floor, Medellin, Antioquia, Colombia; e-mail: lina.pena@udea.edu.co) A counterfeit multivitamin product inducing severe bleeding disorders in humans. Clin Toxicol (Phila) 58:846–848 (Aug) 2020