In a series of shocking recalls, the popular heartburn medicine, Zantac, was associated with the carcinogen, N-Nitrosodimethylamine (NDMA). Zantac is a brand-name version of the drug ranitidine, which was first connected to NDMA on September 13, 2019.
September 9 – The online pharmacy, Valisure, submits a petition to the U.S. Food and Drug Administration (FDA) after finding “high levels” of NDMA in ranitidine products, including Zantac.
September 13 – The FDA releases Safety Information regarding Zantac and other ranitidine medications. According to the announcement, some products contained “low levels” of NDMA, a probable human carcinogen or “substance that could cause cancer.” In the recommendation section, the FDA does not call for individuals to stop taking ranitidine but does encourage them to reconsider their intake.
September 24 – The FDA announces a voluntary recall of ranitidine capsules distributed by Sandoz Inc., due to a nitrosamine impurity.
September 26 – Apotex Corp. issues a voluntary recall of their generic ranitidine tablets on a precautionary basis. Brands include Walgreen’s Wal-Zan® and store brands at Rite Aid and Walmart.
October 1 – USA Today reports about suspended sales of Zantac and other ranitidine products at CVS and Walgreens. The publication confirms recalls from Apotex, Sandoz, and GlaxoSmithKline, but asserts Sanofi, the maker of Zantac, has “no plans to stop distributing or manufacturing the drug outside Canada.”
October 2 – The FDA continues to perform in-house tests on ranitidine products from multiple manufacturers and encourages drug makers to conduct their own laboratory testing for NDMA. In their official statement, the FDA includes: “To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.”
October 6 – The online publication, 24/7 Wall St. questions if the FDA is going “too soft” on Zantac, and reasserts USA Today’s claim that Sanofi has not recalled the drug in the United States.
October 23 – Dr. Reddy’s recalls its generic ranitidine tablets from shelves at Sam’s Club, Walgreens, Walmart, Kroger, CVS, and Target due to confirmed NDMA contamination. Sanofi finally issues a precautionary, voluntary recall on Zantac OTC in the United States. The FDA releases a new, more advanced form of testing called liquid chromatography-mass spectrometry, encourages patients to consider switching their medication, and releases an NDMA Q&A.
October 28 – Perrigo Company plc issues a voluntary, worldwide product recall of their ranitidine products due to possible NDMA impurity. Novitium Pharma LLC and Lannett Company, Inc. recall their ranitidine capsules and syrups, respectively, due to elevated levels of the unexpected impurity, NDMA. After testing, the FDA recommends treating heartburn with products that do not show NDMA, including:
- Pepcid (famotidine),
- Tagamet (cimetidine),
- Nexium (esomeprazole),
- and Prilosec (omeprazole).
**Updates emerge regularly as the FDA investigation continues. Check the FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) here.
Am I At Risk?
Typically, Zantac and other ranitidine medications are only recommended for short-term use. This is good news for you.
NDMA is an environmental contaminant found in water and foods, including grilled meat, dairy products, and some vegetables. Consuming a small amount of NDMA will not cause cancer, but the significant buildup of NDMA over time could be dangerous.
If you were prescribed Zantac (or ranitidine), you should not be at immediately at risk of developing cancer. If you have been taking it for a while, however, you may want to talk to your doctor.
In the event you used Zantac OTC or another over-the-counter ranitidine medication for a sustained period of time, you should also keep an eye on your health.
If you do develop cancer as a result of NDMA exposure, our attorneys at Pratt Clay, LLC are here for you. Start your case against Sanofi or any manufacturer listed above by calling 404-566-9460 and requesting a free consultation today.