Ranitidine is a medication that works by decreasing the amount of acid the stomach produces [1]. It is used to treat and prevent ulcers in the stomach and intestines, as well as to treat gastroesophageal reflux disease (GERD) and a condition called Zollinger-Ellison syndrome, which causes the stomach to produce too much acid [1].
Why was ranitidine recalled?
In 2019, the U.S. Food and Drug Administration (FDA) requested the withdrawal of all prescription and over-the-counter (OTC) ranitidine products from the market due to the presence of N-Nitrosodimethylamine (NDMA), a probable human carcinogen [1][2]. NDMA was found to be present in unacceptable levels in some ranitidine products, and it was discovered that NDMA could form over time in the medication [2].
What are the risks associated with NDMA?
NDMA is classified as a probable human carcinogen [1]. Exposure to NDMA has been linked to an increased risk of developing cancer, although the specific risks depend on the dose and duration of exposure [2].
What are the alternatives to ranitidine?
Several alternatives are available for treating conditions previously managed with ranitidine. These include other histamine-2 (H2) blockers, such as famotidine, and proton pump inhibitors (PPIs), such as omeprazole and lansoprazole [3]. These medications also work by reducing stomach acid production [3].
When did ranitidine products become unavailable?
Following the FDA's request in April 2020, manufacturers began voluntarily recalling ranitidine products from the market [2]. This effectively made ranitidine unavailable for prescription and over-the-counter use in the United States.
Sources:
[1] U.S. Food & Drug Administration. (n.d.). Ranitidine. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/ranitidine
[2] U.S. Food & Drug Administration. (2020, April 1). FDA requests withdrawal of all ranitidine products from U.S. market. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-requests-withdrawal-all-ranitidine-products-us-market
[3] Mayo Clinic. (n.d.). Ranitidine (oral route). Retrieved from https://www.mayoclinic.org/drugs-supplements/ranitidine-oral-route/proper-use/drg-20063393