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Anaphylaxis and glatiramer acetate
Tiffany B Kim1, Jenni Yoon Lee1, Allen Brinker1
1Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.
Background:
Immediate post-injection reactions were commonly observed in registrational trials of glatiramer acetate (GA) for the treatment of multiple sclerosis. Immediate post-injection reactions, characterized by a constellation of symptoms that may occur immediately after injection, can involve signs and symptoms that resemble those of anaphylaxis.
Objective:
The objective of this study is to describe cases of serious anaphylaxis that supported the postmarketing safety labeling change for GA in the United States.
Methods:
A review of the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database and published medical literature was conducted.
Results:
We identified 82 cases of anaphylaxis with GA in FAERS and the medical literature. Six cases reported a fatal outcome (3 anaphylaxis, 3 sudden death). These cases reported anaphylaxis occurring in patients 1 week to 72 months following initiation of GA, including 19 cases that reported anaphylaxis more than 1 year following initiation of GA.
Conclusion:
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.
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