The European Medicines Agency (EMA) has initiated a review of ranitidine medicines after tests showed that some of these products contained the impurity N-nitrosodimethylamine (NDMA).
NDMA is classified as a probable human carcinogen on the basis of animal studies. The EMA is now evaluating data to assess whether patients using ranitidine are at any risk from NDMA. The agency says it will provide information about this as soon as it is available.
In 2018, NDMA and other nitrosamines were found in a number of sartan products, leading to some recalls and to an EU review, which set strict new manufacturing requirements for these medicines.
This latest review of ranitidine medicines was initiated on 12 September 2019 at the request of the European Commission (EC). The review will be carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion will then be forwarded to the EC, which will issue a final legally binding decision applicable in all EU Member States.
The CHMP is also currently working to provide guidance on avoiding nitrosamine impurities in human medicines containing chemically synthesised active substances. The committee will also advise regulatory authorities on actions to take if nitrosamines are found in medicines.