CHMP Recommends Suspension of All Ranitidine Medicines in the EU

May 6, 2020

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of N-nitrosodimethylamine (NDMA).

According to an April 30, 2020 press release issued by EMA, the precautionary recommendation comes after some evidence was found that NDMA may form from the degradation of ranitidine itself with increasing levels over the duration of its shelf life. It is not apparent whether NDMA is formed from ranitidine within the body, some studies suggest it does not and some other studies suggest it does. 

NDMA is classified as a probable human carcinogen, and although the currently available safety data do not demonstrate an increased risk of cancer with ranitidine, NDMA has been found in multiple ranitidine medicines at levels higher than considered acceptable. Additionally, the agency states in the press release that there are unresolved questions surrounding the source of the impurities.

As a result of actions by several national authorities throughout the EU, many ranitidine medicines have not been available in the region for several months. EMA has issued recommended conditions for the suspension to be lifted. These conditions include requirements for companies to provide more data.

Source: EMA