PSA Regarding Zantac/ranitidine and NDMA impurities

Oct 17, 2019, 15:26 PM by Dr. Andrea Glaser

A-Glaser-PSA

Patient/Family Education Regarding Zantac/ranitidine and NDMA impurities:

There has been recent release of information regarding NDMA impurities found in some formulations of Zantac and its generic equivalent ranitidine.  The initial FDA report on this H2 receptor antagonist (Ranitidine and Zantac) was not a recall.  However, to date, at least 3 manufacturers of the over-the-counter preparation of Zantac have voluntarily recalled their product, and, at least 3 pharmacy chains (e.g. CVS) have also pulled Zantac from their shelves.  At this time there is still a great deal of unknown regarding this investigation and the FDA and other regulatory agencies are actively looking into this issue and sharing with the public as they learn more information.

The most recent update from the FDA is provided for your information below. 

The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patients who have been taking ranitidine. In addition, the agency has asked manufacturers of ranitidine to conduct their own laboratory testing to assess levels of NDMA in their ranitidine products and to send samples of ranitidine products to FDA to be tested by our scientists.

FDA will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors to help inform this ongoing investigation. To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. The agency will provide more information as it becomes available.

As per the initial announcement, The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition.

There are multiple drugs on the market that are approved for the same or similar uses as ranitidine (e.g. Pepcid AC (Famotidine) or Axid (Nizatidine) both of which are labeled for and have been studied in children).

Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’s MedWatch program to help the agency better understand the scope of the problem:

  • Complete and submit the report online at www.fda.gov/medwatch/report.htm
  • Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

The actual language from the agency, FDA, can be found at the following URL:  https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine

By Andrea M. Glaser, M.D.
Director, Division of Pediatric Gastroenterology
Medical Director, Adolescent & Childhood Weight Loss Clinic

Also see:  https://www.utmb.edu/pedi/academic-divisions/gastroenterology