The Food and Drug Administration (FDA) has formally withdrawn the H2 blocker ranitidine (Zantac) from the market. This follows a withdrawal issued in September 2019 for 14 lots of prescription ranitidine capsules. The withdrawal of ranitidine now affects all products containing the drug-both prescription and over the counter-and all routes of administration.
The FDA is taking this action because of concerns about levels of the contaminant N-nitrosodimethylamine (NDMA) in the drug, which can increase with time and temperature and pose a risk of cancer. Nitrosamine impurities may increase the risk of cancer if drugs containing them are used over long periods of time in high doses (normal doses are not believed to increase cancer risk). The exact source of NDMA in ranitidine has not been determined, though it appears to be within the drug itself rather than the result of interaction with gastric or intestinal fluid.
Other products approved for similar uses as ranitidine, such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec), do not appear to contain NDMA. NPs should help patients transition to one of these products to manage their gastric hyperacidity and ulcers. Nurses should tell patients to dispose of previously purchased ranitidine by mixing the medication in an unappealing substance (dirt, kitty litter, or used coffee grounds, for example), placing it in a sealed bag, and disposing of it in the household trash.
To read the FDA news release regarding the removal of ranitidine from the U.S. market, go to http://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-rani.