FDA Alert Concerning Ranitidine Products

FDA Alert Concerning Ranitidine Products
Released: 09/25/2019  

By: Heidi Dufrene, Pharmacy Director

Earlier this month, the U.S. Food and Drug Administration (FDA) released a statement alerting patients and health care providers that some formulations of ranitidine contain an impurity classified as a probable human carcinogen, NDMA. Ranitidine, the generic form of Zantac, is an H2 (histamine) blocker and is FDA approved to treat heartburn, peptic ulcer disease and gastroesophageal reflux disease (GERD). Ranitidine is available as a prescription medication and over-the-counter (OTC).

NDMA, N-nitrosodimethylamine, is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables. It is classified as a probable human carcinogen based on laboratory test results. NDMA was an issue with a previous recall of certain blood pressure medications listed as Angiotensin II Receptor Blockers (ARBs) such as losartan and valsartan.

The FDA has announced a consumer-level recall of certain lots of ranitidine manufactured by Sandoz. In addition, the pharmaceutical company, Novartis, has halted distribution of its ranitidine products, as a precaution pending the results of the FDA’s investigation.  Anyone who is taking ranitidine and is concerned should contact their health care provider before stopping any medications. Those taking OTC ranitidine can switch to another OTC medication for heartburn.

For further information, please see below:

For questions regarding the Sandoz recall, patients can call 800-525-8747.

The statement alerting patients and health care professionals of NDMA found in samples of ranitidine may be found at:https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine?elq_mid=21733&elq_cid=2282725

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