Ranitidine-containing medicinal products Article 31 referral: Recommended precautionary suspension to be considered by the European Commission

News Category: 3rd party

Date: 01/05/2020

Ranitidine medicines in tablet and other forms previously recalled in Ireland as a precaution while European Medicines Agency review was ongoing

The 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. As a result, the CHMP is recommending a precautionary suspension to be considered by the European Commission.

It is expected that this recommendation will result in little impact on the Irish market. Many ranitidine medicines have not been available in the EU for several months. This is because national authorities, including the HPRA, recalled them as a precaution while the EMA review was ongoing. In Ireland, the recall of most ranitidine products in tablet and other forms in Autumn 2019 resulted in those medicines being unavailable. Patients, who will have already been switched to alternative medicines as appropriate, can contact their doctor or pharmacist if they have any questions about the medicine they are taking.

The HPRA has requested marketing authorisation holders who continue to have any ranitidine containing medicines on the Irish market to provide a risk-based justification for the continued availability of these products. This relates to a small number of intravenous (IV) presentations of ranitidine at hospital level. The HPRA is also actively working to source suitable alternatives to these products.

More about the procedure

A review of ranitidine was initiated on 12 September 2019 at the request of the European Commission, under Article 31 of Directive 2001/83/EC. The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency’s opinion. The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.

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