Risk monitoring of biologicals derived from adverse reaction management of natalizumab: A systematic review based on serious adverse reaction reports and related regulatory documents

Objective: To analyze the withdrawal reason of natalizumab in depth based on the serious adverse reaction reports and approval channel, and to provide decision references for more safe and effective report method of other biologicals. Methods: We searched MEDLINE, EMbase, and the official websites of Food and Drug Administration (FDA) for case reports, approval channel, and the relevant information of drug marketing or withdrawal. Results: Four …