On the websites of regulatory agencies worldwide, since September 2019, ambiguous information has been appearing about impurities known as N-nitrosodimethylamine (NDMA) in products containing the active substance ranitidine.
NDMA is classified as a probable human carcinogen (a substance that can cause cancer) based on animal studies. It is present in some foods and water and is not expected to be harmful when consumed at very low levels.
In connection with the publication on the official website of the U.S. Food and Drug Administration (FDA) of 01.04.2020 of information on the requirement for manufacturers of medicinal products to withdraw from sale all products containing the active substance ranitidine due to NDMA impurities https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market, the State Expert Center of the Ministry of Health of Ukraine in April 2020 contacted the FDA to clarify the data on these issues.
In the same month, a response was received from the FDA containing links to publicly available web pages with information on nitrosamine impurities that is currently known:
Best Regards,
KC
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov
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It is also known that the European Medicines Agency (EMA) has published a press release 30.04.2020 https://www.ema.europa.eu/en/news/suspension-ranitidine-medicines-eu, which states that the 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 was detected in several ranitidine medicinal products above levels considered acceptable, and the question of the source of the impurities remains unresolved. The EMA will continue to work with national authorities, the EDQM, the European Commission and international partners to ensure that effective measures are taken to prevent the presence of these impurities in medicinal products. The CHMP opinion will be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU member states.
Thus, a final decision has not yet been made on the use or prohibition of medicinal products containing the active substance ranitidine, but the EMA recommends:
For patients
- Medicines containing ranitidine are being suspended in the EU as a precaution because of the presence of low levels of impurities called NDMA.
- Alternative medicines are available. Consult your doctor or pharmacist if you have any questions about alternatives.
- If you have been prescribed ranitidine, your doctor will recommend an alternative.
For healthcare professionals
- Medicines containing ranitidine are being suspended in the EU due to the presence of NDMA impurities.
- Although the exact source of the ranitidine impurity has not yet been determined, NDMA may possibly form from the degradation of ranitidine even under normal storage conditions. Some studies have shown that ranitidine may cause additional formation of endogenous NDMA through its degradation or metabolism in the gastrointestinal tract, although other studies have not.
- Available clinical and epidemiological data do not show that ranitidine increases the risk of cancer.
- Although ranitidine medicines are unavailable, advise patients on alternative medicinal products.
- Healthcare professionals should advise patients who need help, including those who took ranitidine without a prescription, on how to treat and manage conditions such as heartburn and stomach ulcers.
