Ranitidine, commonly known by the brand name Zantac, is a medication that reduces stomach acid production [1]. It belongs to a class of drugs called H2 blockers [2].
What is Ranitidine used to treat?
Ranitidine is prescribed to treat and prevent ulcers in the stomach and intestines [3]. It is also used to treat gastroesophageal reflux disease (GERD), a condition where stomach acid flows back into the esophagus, causing heartburn [4]. Additionally, ranitidine can be used to treat erosive esophagitis, a condition where GERD has caused damage to the lining of the esophagus [5].
Why was Ranitidine recalled?
Ranitidine was voluntarily recalled by manufacturers and subsequently by the FDA due to the presence of N-Nitrosodimethylamine (NDMA), a probable human carcinogen [6][7]. NDMA was found to be present in ranitidine products at unacceptable levels [8]. While NDMA can be present in some foods and water, the levels found in ranitidine were higher than considered safe [8].
When did the Ranitidine recall happen?
Major manufacturers began recalling ranitidine products in September 2019 [6]. The U.S. Food and Drug Administration (FDA) requested the withdrawal of all prescription and over-the-counter ranitidine products from the market in April 2020, due to the persistent presence of NDMA [7].
What are alternatives to Ranitidine?
Several alternatives to ranitidine are available for treating conditions like GERD and ulcers. These include other H2 blockers and proton pump inhibitors (PPIs) [9]. Examples of other H2 blockers include famotidine (Pepcid) and cimetidine (Tagamet) [10]. Proton pump inhibitors, which are generally more potent in reducing stomach acid, include omeprazole (Prilosec) and lansoprazole (Prevacid) [9].
What are the risks associated with Ranitidine use?
The primary risk identified that led to the withdrawal of ranitidine was the contamination with NDMA, a substance classified as a probable human carcinogen [6][7]. Long-term exposure to NDMA has been linked to an increased risk of certain cancers [8].
Can you still get Ranitidine?
Following the FDA's request for withdrawal in April 2020, ranitidine products are no longer legally marketed or available in the United States [7].
What is the difference between Zantac and other heartburn medications?
Zantac (ranitidine) was an H2 blocker, a class of drugs that works by reducing the amount of acid your stomach produces [2]. Other heartburn medications include other H2 blockers like famotidine and cimetidine, as well as proton pump inhibitors (PPIs) such as omeprazole and lansoprazole, which work differently by more effectively blocking acid production [9][10]. The key difference that led to ranitidine's removal was its contamination with NDMA [7][8].
Sources:
[1] https://www.ncbi.nlm.nih.gov/books/NBK537221/
[2] https://www.medicinenet.com/ranitidine/article.htm
[3] https://www.nhs.uk/medicines/ranitidine/
[4] https://www.drugs.com/ranitidine.html
[5] https://www.rxlist.com/ranitidine-side-effects-drug-center.htm
[6] https://www.drugpatentwatch.com/news/ranitidine-recall-zantac-ndma-fda-drug-safety
[7] https://www.fda.gov/drugs/drug-recalls/ FDA-requests-removal-all-prescription-and-over-counter-ranitidine-z-drugs-products-market
[8] https://www.cancer.org/latest-news/why-was-zantac-recalled.html
[9] https://www.health.harvard.edu/diseases-and-conditions/gerd-medications
[10] https://www.mayoclinic.org/drugs-supplements/ranitidine-oral-route-parenteral-route/proper-use/drg-20068211