As you may be aware, there have been statements from the FDA regarding N-nitrosodimethylamine (NDMA) being found in samples of ranitidine products. NDMA is considered a possible human carcinogen as it has been found to increase the occurrence of cancer in animal studies; moreover, this was the same carcinogen found last year in valsartan.
A brief timeline of events: (click to zoom in)
Here’s what you as a provider need to know:
If you have any questions or concerns regarding the recall or would like resources for your practice, please feel free to check the FDA website for regular updates or contact the SVHP Pharmacist for additional resources. We hope to continue providing safe and excellent quality care for our mutual patients.
References: 1. (2019). FDA Updates and Press Announcements on NDMA in Zantac (ranitidine). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine 2. Woodcock, JW (2019). Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. Retrieved from https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine 3. Garcia, SE (2019). Zantac pulled from shelves by Walgreens, Rite Aid and CVS over carcinogen fears. Retrieved from https://www.nytimes.com/2019/09/30/health/zantac-recall-cancer.html 4. (2015). Eight ways to prevent heartburn. University of Utah Health Care. Retrieved from: https://healthcare.utah.edu/healthfeed/postings/2015/08/080615_prevent-heartburn.php
(c) 2019, SVHP. This document contains proprietary and confidential information and shall not be used, disclosed, or reproduced, in whole or in part, without the prior written consent of St. Vincent’s Health Partners, Inc. The contents of this document are provided on an “as is” basis. Nothing in this publication is intended as medical advice and it should not be taken to replace, subvert, or otherwise modify medical advice from, or the clinical judgement of, a qualified medical practitioner.
Empowering health care delivery that ensures patients get the right care, at the right time, in the right place.