The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the suspension of all ranitidine medicines in the European Union due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).
Ranitidine medicines are used to reduce the production of stomach acid in patients with conditions such as heartburn and gastric ulcers.
Based on animal studies, NDMA is classified as a probable human carcinogen (a substance that could cause cancer). 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 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.
For this reason, as a precautionary measure and while awaiting further data from the manufacturers, the CHMP has recommended that the sale of all ranitidine-based medicinal products be suspended in the European Union.