The National Medicines Directorate suspended the marketing and consumption in the country of drugs containing ranitidine.
El Salvador joined the list of countries that have suspended oral use of ranitidine-containing drugs following warnings from international experts that they could cause cancer.
Ranitidine has been used to treat peptic acid disease: heartburn, gastritis, stomach ulcer, esophageal reflux, among others.
Consumption of this drug can also cause adverse reactions, according to the US National Library of Medicine, according to international media, including:
– Constipation
– Diarrhea
– Stomach upset
– Vomiting
– A stomachache
The National Medicines Directorate (DNM) indicated that the decision to withdraw this drug from the Salvadoran market is in line with the health alerts issued in this regard by the United States Food and Drug Administration (FDA). in English) and the European Medicines Agency (EMA).
The two bodies have noted that the presence of an impurity identified as N-Nitrosodimethylamine (NDMA), a substance that could cause cancer, has been detected in ranitidine-based medicines, according to international media publications.
READ MORE: Medicines with ranitidine are banned in El Salvador
The executive director of the DNM, Francisco Cortez Morales, explained through a memorandum dated February 2, 2021 that both the FDA and the EMA established that under normal storage conditions, and even more so at high temperatures exceeding established by the manufacturer, increase NDMA levels in ranitidine, thereby increasing the risk of cancer in people exposed to higher than acceptable NDMA levels over a long period of time.
The DNM will not only report that it withdrew these drugs from the List of Over-the-Counter Medicines in El Salvador, but will also monitor their sales; it will also notify health professionals about the new provision, so that they can give their patients other therapeutic alternatives.
“It is not omitted to state that this measure does not affect the supply of drugs, since there are other drugs on the market, with other active ingredients, which have the same therapeutic indications as omeprazole, pantoprazole or lansoprasole; and receptor antagonists. H2, like famotidine, “the DNM noted.
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