Argentina: Suspension of marketing of medicinal preparations containing ranitidine

 

As a preventive measure, the marketing throughout the national territory of medicinal preparations containing ranitidine as an active pharmaceutical ingredient (API), as a monodrug or in association with other APIs, in its oral pharmaceutical forms, and in all its concentrations and presentations, has been suspended in Argentina.

So was it announced in the decision DI-2020-9209-APN-ANMAT#MS.

The laboratories holding certificates of medicinal specialties that contain RANITIDINE as an Active Pharmaceutical Ingredient (API), as a monodrug or in association with other IFAs, in oral pharmaceutical forms, must withdraw from the market all the units covered by this measure, in a period of 30 calendar days from the entry into force of this provision, and must submit the corresponding supporting documentation to the National Institute of Medicines.

The decision was justified with the following facts:

The Department of Pharmacovigilance and Risk Management reported that, at the request of the European Commission, the European Medicines Agency (EMA) had begun a review of medicines containing ranitidine after observing an impurity called N-nitrosodimethylamine (NDMA) in the tests carried out on these products.

NDMA is classified as a probable human carcinogen based on animal studies and is present in some foods or water supplies, but is not expected to cause harm when ingested at very low concentrations.

The EMA, in April 2020, reported that there was some evidence that NDMA could be formed from the degradation of ranitidine itself, with increasing concentrations during its useful life, that it was not clear if NDMA could also be formed within the organism and that the Committee for Medicinal Products for Human Use (CHMP) had recommended preventively suspending all medicines containing ranitidine in the European Union.

For this reason, Argentina has made a similar decision.