Катрен Стиль
Появились данные о риске опасного влияния импортного иммунодепрессанта на печень
Компания АО «Рош-Москва» сообщает о новых данных по безопасности лекарственного препарата «Эсбриет» (пирфенидон). Клинические испытания ЛС выявили риск лекарственного поражения печени. Информационное письмо об этом опубликовано 27 февраля на сайте Росздравнадзора.
«Эсбриет» (пирфенидон) является иммунодепрессивным средством. Препарат применяется для терапии идиопатического легочного фиброза у взрослых. «Эсбриет» — единственный зарегистрированный в России препарат с действующим веществом пирфенидон.
Производитель информирует, что у отдельных пациентов, принимавших препарат, были установлены клинически значимые случаи лекарственного поражения печени, включая случаи с летальным исходом. Это может быть вызвано идиосинкразической реакцией на действующее вещество — пирфенидон.
На основании этих данных производитель в ближайшее время обновит инструкцию по медицинскому применению лекарственного препарата. В нее будут добавлены описание рисков клинически значимого лекарственного поражения печени и рекомендации по дополнительному мониторингу функции печени при наличии клинических признаков или симптомов, указывающих на ее повреждение.
Ранее производители дерматологических препаратов «Неотигазон» и «Роаккутан» напомнили об опасном тератогенном действии этих ЛС.
28 февраля 2020
Фото: depositphotos.com
Выпуск: №193, февраль 20203110 просмотров
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