В препаратах от язвы желудка обнаружены канцерогенные примеси
16 сентября 2019
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№188, сентябрь 2019
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В препаратах от язвы желудка обнаружены канцерогенные примеси
Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (Food and Drug Administration, FDA) сообщает об обнаружении канцерогенных примесей в препаратах, содержащих ранитидин. Пресс-релиз с соответствующим заявлением опубликован 13 сентября на сайте управления.
Речь идет о наличии в ранитидине малых количеств вещества N-нитрозодиметиламин (NDMA), которое является канцерогеном и в некоторых случаях может привести к развитию онкологических заболеваний. Источник примесей NDMA в лекарственных препаратах не установлен. FDA продолжает дальнейшие исследования.
Управление отмечает, что пациентам не следует прекращать прием ранитидина, поскольку польза от лекарств превышает возможные риски. Несмотря на канцерогенный характер примесей, обнаруженное FDA количество вещества в ранитидине почти не превышает «естественных» значений концентрации MDMA, которое могут содержать некоторые пищевые продукты.
Тем не менее, FDA продолжит дальнейшие исследования препаратов с ранитидином на рынке для определения их возможной опасности. Пациентам, желающим прекратить терапию ранитидином, управление советует обратить внимание на другие ЛС, которые имеют схожие показания к применению.
Ранитидин — блокатор гистаминовых H2‑рецепторов. По данным ГРЛС, показаниями к применению ЛС является язвенная болезнь желудка и двенадцатиперстной кишки.
Напомним, что примеси N-нитрозодиметиламин (NDMA) и N-нитрозодиэтиламин (NDEA) в прошлом году были обнаружены в препаратах с валсартаном, изготовленным из индийской и китайской фармацевтических субстанций. В результате из оборота в России было отозвано более 600 серий ЛС. В июне этого года Росздравнадзор выпустил официальное заявление, что все сартаны, находящиеся в данный момент на рынке, безопасны для применения.
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