Anaphylaxis and glatiramer acetate
As these reactions have implications for prescribing decisions and patient management, the FDA issued a labeling change notification to update the WARNINGS AND PRECAUTIONS section and add a BOXED WARNING to the United States prescribing information for GA. A Drug Safety Communication was also issued to inform the public about this update.
Authors
- Jenni Yoon Lee
- Laura Baldassari (ORCID: https://orcid.org/0000-0003-1795-1542)
- Allen Brinker
- Tiffany Kim (ORCID: https://orcid.org/0009-0008-1556-9861)
- Daniela A Pimentel Maldonado
- Alice Hughes
- Paul R. Lee (ORCID: https://orcid.org/0000-0002-6681-562X)
- Vicky Chan (ORCID: https://orcid.org/0000-0003-4638-3855)
Institutions
- Center for Drug Evaluation and Research (US)
Publication Details
- Journal
- Multiple Sclerosis Journal
- Published
- 2025-10-26
- DOI
- https://doi.org/10.1177/13524585251382397
- Citations
- 1
- Primary Topic
- Drug-Induced Adverse Reactions
- Type
- article
- Field-Weighted Citation Impact
- 1.39