Suspension of medicinal products containing ranitidine in the European Union

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the sale of all ranitidine-based medicinal products be suspended in the European Union. This is due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).

Ranitidine
Ranitidine-based medicinal products are used to reduce the production of stomach acid in patients with conditions such as heartburn and gastric ulcers. They were available both over the counter and on medical prescription.

Alternative medicinal products based on other active substances which offer the same solution for this type of pathology are available.

NDMA
NDMA is a nitrosamine impurity which has also been found in other medicinal products, including those based on sartans. Based on animal studies, NDMA is classified as a probable human carcinogen (a substance which may cause cancer). It is present in certain foodstuffs and in water resources, but it is not expected to be harmful when ingested in very small quantities.

Available studies do not show that ranitidine increases the risk of cancer. However, levels of NDMA beyond those considered acceptable have been found in several ranitidine-based medicinal products and some questions regarding the source of these impurities remain unresolved.

For this reason, as a precautionary measure and while awaiting further data from the manufacturers, the CHMP has recommended the suspension of these medicinal products in the European Union.

Belgium

In Belgium, the medicinal products in question are Zantac, Ranitidine EG, Ranitidine Mylan and Ranitidine Sandoz. Raw materials used by pharmacists to make magistral preparations are also concerned.

In September 2019, as a precaution, these companies recalled or quarantined ranitidine-based medicinal products after the detection of said impurity in these medicinal products.

These medicinal products have therefore been unavailable for purchase on the Belgian market since September 2019.

Recommendations for patients

Alternative treatments with medicinal products based on other active substances are available. Contact your doctor and/or pharmacist if you have questions regarding your treatment.

Last updated on
08/05/2020