மூலக்கூறு மருந்துகள் & ஆர்கானிக் செயல்முறை ஆராய்ச்சி இதழ்

சுருக்கம்

Diverticulitis Associated with BaricitinibUse:Adverse Events- Signal Review

RoaaAlamri

Baricitinib is   antirheumatic drug that belongs to disease-modifying antirheumatic drugs (DMARD). Diverticular disease (diverticulosis, diverticulitis) is a broad term that refer to the presence of diverticula. It is a small pouches in the large intestinal (colonic) wall. A signal of Baricitinib and diverticulitis was retrieved from Pharmacovigilance Risk Assessment Committee (PRAC) new signals. Saudi Food and Drug authority (SFDA) has conducted this safety review based on that.The purpose of this review is to evaluate the risk of diverticulitis in association with Baricitinib use. Methods: Signal Detection team at SFDA have retrospectively searched World Health Organization (WHO) database (Vigibase) and the National Pharmacovigilance Center (NPC) database to retrieve all reported cases of Baricitinib and diverticulitis.Local Cases:The search in the National Pharmacovigilance Center (NPC) database resulted in zero cases.On March 25th, 2020, a search in the World Health Organization (WHO) database (Vigibase) was conducted to retrieve all reported cases between 2017 and 2020 via signal detection tool (Vigilyze).The search resulted in 23 Individualized Case Safety Reports (ICSRs).One report was excluded due to duplication.