The General Directorate of Medicines has ordered the suspension of the sale of these medicines, as they may be carcinogenic.
The National Directorate of Medicines (DNM) has suspended the marketing and consumption of orally administered medicines containing the active substance ranitidine since the beginning of February.
Ranitidine has been used to treat peptic acid disease: heartburn, gastritis, gastric ulcer, esophageal reflux, among others.
DNM Executive Director Francisco Cortez Morales, in a memorandum dated February 2, 2021, notified the Minister of Health, Francisco Alabí, that the decision is made due to the fact that both the US Food and Drug Administration (FDA) stands for English) and the European Medicines Agency (EMA, same case) have issued a health alert in connection with this active ingredient.
According to Cortez Morales, the two organisms determined that under normal storage conditions, and even more so at elevated temperatures that exceed those set by the manufacturer, levels of N-nitrosodimethylamine (NDMA) in ranitidine increase, thus increasing the risk of cancer. in people exposed to higher than acceptable levels of NDMA over a long period of time.
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DNM reported not only that it had removed these medicines from the list of over-the-counter medicines, but that it would also monitor their sales; It will also inform health professionals about the new provision so that they can offer their patients other therapeutic alternatives.
DNM reported not only that it withdrew these drugs from the list of over-the-counter drugs, but that it would also monitor their sales.
‘It should not be overlooked that this measure does not affect the supply of medicinal products, as there are other medicinal products on the market, with other active ingredients, which have the same therapeutic indications as omeprazole, pantoprazole or lansoprasole; and H2 receptor antagonists, such as famotidine, “DNM noted.
Oncologist Raúl Lara said that ranitidine “has been suspended for some time by the FDA, because in high and sustained doses it showed a slight increase in certain cancerous tumors.”
According to Lara, in other countries this drug has been easily replaced by others available in pharmacies and hospitals.
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For Dr. Carlos Ramos Hinds, the measure taken by DNM is correct, “because it seems that due to inadequate storage, a compound that has been shown to be carcinogenic could be generated.”
Ramos Hinds explained that it was prescribed as an antacid to treat problems with acidic peptic disease and agreed that there are other options on the market.
This measure, as indicated, aims to minimize the risk of exposure of the population to this component.
Dr. Ricardo Lara, a health worker, confirmed that the DNM note regarding the aforementioned medicine has already started to be distributed to the medical staff, although he is not so convinced of the measure.
According to the doctor, it is feared that in the long run the population that is used to being prescribed ranitidine when consulted for stomach problems, will fall into the abuse of substitute drugs, which in the long run the institutions will provide.
The drug has been used to treat problems such as gastritis, esophageal reflux, among others. The measure is to avoid the risk of developing cancer.
DNM has published guidelines for drug withdrawal