Multiple Sclerosis Research Repository

Thank you for your inquiry regarding the recent Drug Safety Communication for Copaxone, issued on January 22, 2025. Since at least 2001, labeling for Copaxone has listed “anaphylactoid reaction” as an adverse reaction identified in the postmarketing experience. FDA and other regulatory agencies became aware of fatal and delayed anaphylaxis cases associated with Copaxone more recently, which led to a comprehensive safety evaluation of all available postmarket data (since 1996) and the determination that labeling changes and a Drug Safety Communication were warranted in the context of this new safety information.