Medicinal products containing the active substance ranitidine have been recalled from the Swiss market since they contain traces of the nitrosamine NDMA (N-nitrosodimethylamine). Analyses by the Swissmedic Official Medicines Control Laboratory (OMCL) found small quantities of this impurity in all ranitidine preparations authorised in Switzerland. While there is no acute risk to health, patients who have been prescribed any of the medicines listed below are asked to contact their doctor to discuss a switch in their treatment.
23.09.2019
Following a notification of suspected presence in the USA, in Summer 2019 regulatory authorities worldwide started analysing ranitidine preparations for contamination with the nitrosamine NDMA.
As a precautionary measure, Swissmedic stopped the delivery of ranitidine products during its investigations. After measurements by Swissmedic and the marketing authorisation holders responsible confirmed the presence of contamination with NDMA in finished products containing the active substance ranitidine, Swissmedic ordered the withdrawal of affected batches.
Consequently, no medicinal products containing the active substance ranitidine will be available in Switzerland until further notice. The medicines concerned are currently being withdrawn from the market in other countries as well. Various other medicinal products are available for the same indications applicable to ranitidine.
Patients treated with any of the following products should contact their doctor so that their treatment can be switched.
| Preparation | Authorisation number/dispensing category | Withdrawal of batches |
|---|---|---|
| Ranimed, film-coated tablets | 54057 (B) | all batches |
| Ranitidin-Mepha, Lactab | 53664 (B) | all batches |
| Zantic solution for injection 50 mg/5 mL | 44374 (B) | all batches |
The reasons for contamination are being investigated at international level. Swissmedic is working closely with other national regulatory authorities and partners such as the EDQM (European Directorate for the Quality of Medicines) to draw up guidelines designed to ensure that medicinal products remain free of nitrosamine-containing impurities in future.
Information for patients
Medicines containing ranitidine are used for controlling gastric acid production in heartburn and reflux and for protecting the stomach.
Since the very slight contamination of ranitidine products with nitrosamines does not pose an acute risk, those affected should not stop taking these medicines on their own initiative.
Patients who are currently being treated with ranitidine medicines should contact their doctor or pharmacist if they have any questions. They must discuss any switch in treatment with their doctor. Various medicines with active substances other than ranitidine can be used as alternative treatments for the same illnesses.
Nitrosamines
In the summer of 2018, NDMA and related substances (so-called nitrosamines) were detected in a number of blood pressure lowering medicines containing sartans. This resulted in recalls worldwide and new requirements relating to the manufacture of sartan-containing medicinal products.
The potential risks of nitrosamines in medicinal products are associated with very long-term treatment. Nitrosamines also occur in nature, in smoking products or certain foods. If NDMA is absorbed in very small amounts, additional risks are very low.