Published: 26/09/2019 18: 22
The action has caution and preventive character since animal studies rank the NDMA substance as a likely human anticancer agent. NDMA is A nitrosamine and can be found in water and food, but is not expected to cause damage when ingested at very low levels.
After detection of the impurity called N-nitrosodimethylamine (NDMA), the Brazilian Health Regulatory Agency (Anvisa) will suspend the importation, the use, and marketing of the ranitidine pharmaceutical input, Manufactured By Saraca Laboratories Limited, located in India.
The action has caution and preventive character since studies in animals rated NDMA as a likely human anticancer agent. NDMA is A nitrosamine, substance that can be found in water and in foods, but is not expected to cause damage when ingested at very low levels.
In the US, the agency responsible for the regulation of drugs, FDA (Food and Drug Administration), has identified low levels of impurities in medicaments, but there is still a definition of the actual risk of such drugs, since the identified quantities are somewhat higher than that which can be found in common foods.
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With the suspension, the active pharmaceutical input of this particular manufacturer may no longer enter the country. The Anvisa is evaluating the data and will provide more information so long as they are available.
[huge_it_slider id=”15″]Ranitidine medicaments have a well-established safety profile and are widely used for azole and stomach ulcers.
Patients who have some doubts on the current treatment may speak with their medical or pharmaceutical. At this time there is no suspension recommendation, but there are several other drugs used for the same indications that can be used as therapeutic alternatives.
Lastly, the Anvisa will continue to act to prevent nitrosamines in the medicaments and act with its international partners to protect the patient ‘s health, with the adoption of effective measures to prevent these impurities from being present in the medicaments.