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.

18 September 2020: The EMA's human medicines committee (CHMP) has confirmed its recommendation to suspend all ranitidine medicines in the EU due to the presence of low levels of the impurity NDMA. This follows a re-examination of CHMP's April 2020 opinion, which was requested by one of the companies which markets ranitidine medicines.

Further information is available here.

Other H2RAs

Shortages of H2RAs are expected throughout 2020. Please check availability before prescribing

Last updated: 14-10-2020

 

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

 

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