1.3.1 H2-receptor antagonists

Ranitidine

30 April 2020: The European Medicines Agency has recommended the suspension of all ranitidine medicines due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal studies. It is present in some foods and water supplies and is not expected to cause harm when ingested at very low levels.

Available safety data, including clinical and epidemiological data, do not show that ranitidine increases the risk of cancer, and any possible risk is likely to be very low. However, NDMA has been found in several ranitidine medicines above levels considered acceptable, and there are unresolved questions about the source of the impurities.

The EMA has recommended conditions for lifting the suspension of ranitidine medicines, including requirements for companies to provide more data.

Further information is available here

 

Home > Formulary > Chapters > 1. Gastrointestinal > 1.3 Antisecretory drugs and mucosal protectants > 1.3.1 H2-receptor antagonists

 

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