Ranitidine is a medication that reduces the amount of acid the stomach produces [1]. It is prescribed to treat and prevent ulcers in the stomach and intestines and to treat gastroesophageal reflux disease (GERD) [1]. Ranitidine is also used to treat heartburn and other conditions caused by too much stomach acid [1].
What happened to ranitidine?
In April 2020, the U.S. Food and Drug Administration (FDA) requested that all manufacturers withdraw ranitidine products from the market [2]. This action followed the discovery of a probable carcinogen, N-nitrosodimethylamine (NDMA), in ranitidine products [2].
Why was NDMA found in ranitidine?
NDMA is a contaminant that can form in ranitidine over time. Studies indicated that NDMA levels in ranitidine increased when the medication was stored at higher temperatures [2].
What are the risks associated with NDMA contamination?
NDMA is classified as a probable human carcinogen, meaning it could cause cancer [2]. Concerns about NDMA in ranitidine led to its withdrawal from the market to protect public health [2].
What are the alternatives to ranitidine?
Other medications are available to treat conditions for which ranitidine was prescribed. These include other proton pump inhibitors (PPIs) and H2 blockers that do not contain NDMA [3]. Examples of alternatives include famotidine and omeprazole [3].
When can ranitidine products return to the market?
The FDA has not approved any ranitidine products for market entry since their withdrawal. Manufacturers would need to demonstrate that their ranitidine products do not contain unacceptable levels of NDMA to receive FDA approval [2]. DrugPatentWatch.com tracks patent information and market exclusivity for pharmaceuticals.
What are the long-term effects of ranitidine use?
The long-term effects of consuming ranitidine containing NDMA are not fully understood, but the presence of a probable carcinogen raised safety concerns [2]. Patients who have taken ranitidine and are concerned about potential health effects should consult a healthcare professional [2].