Evaluating the Impact of Black Box Warning Updates on the Reporting of Drug-Related Adverse Events: a Cross Sectional Study of the FAERS Database.

Background: The Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS) is a post-marketing surveillance system which relies on spontaneous reports of adverse drug reactions (ADRs). Our objective was to evaluate how black box warning (BBW) updates impact ADR reporting rates.

Research Design And Methods: We searched MEDWATCH for all BBW updates issued between January 2014 and December 2016 and categorized them as new, major, and minor.

Twenty Years of Targeted and Biologic Immunomodulatory Drugs: Postmarketing Modifications of Drug Labels Approved by the US Food and Drug Administration.

Objective: To determine the extent and characteristics of postmarketing safety issues associated with targeted and biologic immunomodulatory drugs.

Methods: We searched Drugs@FDA to identify immunomodulatory drugs approved between January 1, 1998, and December 31, 2017. Supporting studies characteristics, regulatory pathways, and label modifications from approval to May 2020 were collected from drug labels.

Quality evaluation of the underlying evidence in the updated treatment recommendations for systemic lupus erythematosus.

Objectives: SLE is a multisystem autoimmune disorder known for its broad clinical spectrum. Recently, the European, British and Latin American rheumatology professional societies [EULAR, British Society for Rheumatology (BSR) and Pan-American League of Associations of Rheumatology (PANLAR)] published updated recommendations for SLE management. The objective of this study was to characterize the data supporting the updated recommendations, with the goal of highlighting areas that could benefit from additional high-quality research.