A nitrosamine impurity (NDMA, N-nitrosodimethylamine) has been detected in medicines based on ranitidine. The European Medicines Agency (EMA) has started a review. As a precautionary measure, the companies involved are recalling the medicine or placing the medicines in quarantine.
The companies are testing the active pharmaceutical ingredient (API) and end products to identify contaminated batches. As a precautionary measure, the medicines based on ranitidine are either placed in quarantine at the companies affected or recalled at the pharmacy level.
In Belgium, the medicines Zantac Ranitidine EG, Ranitidine Mylan and Ranitidine Sandozare concerned. Three marketing authorization holders of the active ingredient used by the pharmacies to make preparations (Fac secundum Artem; 2Pharma; Fagron group) are also testing their products.
Recommendations for patients
You can continue to use the medicines in your possession. When you can no longer get your medication, please contact your treating physician and/or pharmacist. Alternative treatments with medicines based on other active ingredients are available.
Medicines with ranitidine are used to reduce the production of gastric acid in patients with conditions such as heartburn and stomach ulcers. They are available both with and without a medical prescription. There are alternative medicines available based on other active ingredients that offer the same solution for these kinds of conditions.
NDMA is one of the impurities that is also found in medicines based on sartans. NDMA is classified as possibly carcinogenic for humans (a substance that could cause cancer) based on animal testing. It is present in some foodstuffs and in water sources, but is not expected to cause damage when ingested in very small quantities. Where nitrosamines are found in drugs, the risk of developing cancer is low.
After the detection of nitrosamines in sartans, the EMA set up guidelines for marketing authorization holders for the sale of drugs to prevent the presence of nitrosamines in drugs for human use that contain chemically synthesized active ingredients.