Under Article 31 of Directive 2001/80/EC, the review of
ranitidine containing medicines was initiated at the request to the European
Commission. This review will be carried out by the Committee for Medicinal
Products for Human Use (CHMP). The CHMP opinion will then be forwarded to the
European Commission, which will issue a final legally binding decision
applicable in all EU Member States.
NDMA is classified as a probable human carcinogen (a
substance that could cause cancer) on the basis of animal studies. It is
present in some foods and in water supplies but is not expected to cause harm
when ingested in very low levels. In 2018, NDMA and similar compounds known as
nitrosamines were found in several blood pressure medicines known as ‘sartans’
leading to recalls.
EMA is
evaluating the data to assess whether patients using ranitidine are at any risk
from NDMA and will provide information about this as soon as it is available.
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