Multiple sclerosis (Houndmills, Basingstoke, England) · 2025
Anaphylaxis and glatiramer acetate.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kim Tiffany B, Lee Jenni Yoon, Brinker Allen, Lee Paul R, Baldassari Laura E, Pimentel Maldonado Daniela A, Hughes Alice, Chan Vicky
Аннотация
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.
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.