FDA распорядилось исключить беременность из противопоказаний к статинам
22 июля 2021
Фото: depositphotos.com
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№211, июль 2021
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FDA распорядилось исключить беременность из противопоказаний к статинам
Управление по контролю за продуктами и лекарствами США (FDA; Food and Drug Administration) обращается к производителям лекарственных препаратов группы статинов (аторвастатин, ловастатин, флувастатин, питавастатин, правастатин, розувастатин, симвастатин) с требованием изменить инструкции по применению. Из них должно быть исключено противопоказание «Применение во время беременности». Заявление об этом опубликовано 20 июля на сайте управления.
FDA напоминает, что противопоказание означает полный запрет на использование лекарственного средства, поскольку риск его влияния на организм значительно превышает пользу от применения. Однако в управлении считают, что статины в некоторых случаях могут быть единственным средством, способным предотвратить потенциально смертельные случаи, связанные с сердечно-сосудистыми заболеваниями.
В связи с этим FDA считает, что риски осложнений во время беременности следует перенести в раздел «Особые указания» с подробным описанием опасности приёма статинов. Это позволит врачам назначать препараты пациентам в исключительных случаях, например женщинам, перенёсшим инсульт, инфаркт миокарда или имеющим другие тяжёлые заболевания.
При этом в инструкции должно остаться указание на прекращение приёма статинов, если пациентка узнает о беременности, а также запрет на грудное вскармливание во время терапии препаратами.
Ранее компания «АстраЗенека» внесла изменения в инструкцию по применению противоопухолевого препарата «Тагриссо». В неё было добавлено новое показание к применению.
Катрен Стиль
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