EMA’s human medicines committee (CHMP) has recommended the suspension of all ranitidine medicines in the EU 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 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.
There is some evidence that NDMA may form from the degradation of ranitidine itself with increasing levels seen over its shelf life. It is not clear whether NDMA can also be formed from ranitidine inside the body. Some studies suggest that it can while others do not. Given the uncertainties, the CHMP has recommended a precautionary suspension of these medicines in the EU...
Full text at GMPnews.Net