October 24, 2019
Following the discovery of a potential human carcinogen in ranitidine-containing products, the U.S. FDA has released multiple updates regarding manufacturer recalls and the current status of its investigation.
On September 12, 2019, the agency announced that certain products containing the active pharmaceutical ingredient (API) ranitidine were found to contain N-nitrosodimethylamine (NDMA). Ranitidine is the active ingredient in the popular over-the-counter (OTC) heartburn medication Zantac®, which is manufactured by Sanofi. Ranitidine is also found in generic versions of Zantac, as well as in prescription medications approved to treat gastroesophageal reflux disease and prevent stomach or intestinal ulcers. NDMA is considered a potential human carcinogen, or cancer-causing agent, and was the reason for multiple recalls of angiotensin II receptor blocker (ARB) medications throughout much of 2018.
A growing number of manufacturers have voluntarily recalled their ranitidine-containing products, while retailers such as Walgreens, Wal-Mart, CVS, and Rite-Aid have pulled OTC ranitidine from their shelves regardless of the particular brand and product’s recall status. To help the American public track the current status of ranitidine recalls and NDMA investigations, the FDA has established a central webpage for press announcements and updates, as well as a separate “Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)” page. Specific information regarding individual manufacturers’ recalls can be found on the FDA’s website.
As of October 24, 2019, manufacturers who have issued recalls of their ranitidine products include Apotex, Dr. Reddy’s, Perrigo, Sandoz, and Sanofi. The FDA has identified several alternatives to OTC ranitidine that are free of NDMA, and advises that consumers who take OTC ranitidine may wish to switch. These alternatives include the following brand name medications and their generics: Pepcid® (famotidine – McNeil), Tagamet® (cimetidine – GlaxoSmithKline), Nexium® (esomeprazole – AstraZeneca), Prevacid® (lansoprazole – Takeda), and Prilosec® (omeprazole – Procter & Gamble). Consumers who take prescription ranitidine should speak to their healthcare provider about other treatment options. Multiple medications currently available in the US are FDA-approved for the same or similar indications.