Ranitidine is a medication that was used to decrease the amount of acid produced in the stomach. It belongs to a class of drugs called histamine H2-receptor antagonists, commonly known as H2 blockers [1]. These medications work by blocking the action of histamine, a substance that stimulates the stomach to produce acid [1].
What was ranitidine used to treat?
Ranitidine was prescribed to treat and prevent ulcers in the stomach and intestines, as well as gastroesophageal reflux disease (GERD) and a condition called Zollinger-Ellison syndrome, which causes the stomach to produce too much acid [1].
Why is ranitidine no longer available?
The availability of ranitidine was affected by concerns over a contaminant called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen [2]. In 2019, regulatory agencies like the U.S. Food and Drug Administration (FDA) announced that some ranitidine products contained unacceptable levels of NDMA [3]. This led to voluntary recalls by manufacturers and eventually the removal of ranitidine products from the market [3].
What are alternatives to ranitidine?
Other medications are available to treat conditions like GERD and stomach ulcers. These include other H2 blockers, such as famotidine and cimetidine, as well as proton pump inhibitors (PPIs) like omeprazole and lansoprazole, which are generally more potent in reducing stomach acid [1].
What is NDMA and why was it found in ranitidine?
N-nitrosodimethylamine (NDMA) is a chemical compound that can form during the manufacturing process of some medications or can develop over time as a drug degrades [2]. Investigations suggested that NDMA could form in ranitidine products due to the inherent instability of the ranitidine molecule itself [2].
What are the risks associated with NDMA exposure?
Long-term exposure to NDMA may increase the risk of cancer [2]. The levels of NDMA found in some ranitidine products exceeded the acceptable daily intake levels set by regulatory bodies [3].
Sources:
1. https://www.drugpatentwatch.com/drug/ranitidine
2. https://www.fda.gov/drugs/drug-safety-and-availability/ranitidine-and-ndma-contamination
3. https://www.drugpatentwatch.com/blog/ranitidine-ndma-contamination-and-recalls