The Department of Health and Social Care (DH) has announced that all preparations of ranitidine, including tablets, effervescent tablets, oral solution and injection, will continue to remain out of stock until further notice.
The latest supply restriction on the range of ranitidine products came after the Medicines and Healthcare products Regulatory Agency (MHRA) suspended all licenses for ranitidine products following a recommendation from European Medicines Agency (EMA).
All formulations of ranitidine are affected due to on-going regulatory investigations into the presence of N-nitrosodimethylamine (NDMA), a contaminant, in samples of ranitidine active substance.
Last year, the EMA’s human medicines committee recommended to suspend all ranitidine medicines in the EU due to the presence of low levels of the impurity.
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 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 this impurity.