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UT Health Austin Heartburn and Esophageal Disorders Center


STATEMENT ON ZANTAC/RANITIDINE RECALL

Millions of Americans suffer from GERD and many find relief with Zantac and its generic equivalent Ranitidine. You may have heard that the FDA recently announced a voluntary recall by several manufactures of Ranitidine. The reason for the recall is that these medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). NDMA is classified by the FDA as a probable carcinogen and environmental contaminant found in water and foods. It is important to note that only exposure to high levels for long periods of time has been deemed unsafe. However, out of an abundance of caution, the manufacturers have stopped production.

What patients should know:

  • Interestingly, the FDA did NOT recommend stopping Zantac or Ranitidine at this time.
  • While many retailers like CVS, Walgreens, and Walmart are removing the drug, this is not an official recall.
  • No brands of the generic Ranitidine are affected and Novartis, the maker of the brand-name Zantac, continues to manufacture and ship the product.
  • If your physician prescribed Ranitidine or Zantac, contact your physician prior to stopping your medication or ask to be switched to another medication, as there are multiple alternatives.
  • If you have been prescribed or take any of the H2 blockers (Pepcid/Famotadine or Zantac/Ranitidine) or PPIs (Prilosec, Nexium, Dexilant, Aciphex, Protonix), perhaps now is a great time to discuss GERD with a healthcare professional. At UT Health Austin we have assembled a multi-specialty team of GERD experts to help patients get and stay healthy.

UT Health Austin surgeon Tripp Buckley, MD states, “Over 40 million Americans suffer from gastro-esophageal reflux disease (GERD) and often find temporary relief from heartburn from over the counter or prescription medications like Zantac, Pepcid, Nexium, or Prilosec and there generic forms. It is important to note however that the D in GERD is for disease and patients that suffer from just more than occasional heartburn should have their GERD properly diagnosed and managed by a medical expert. 15% of patients with long-standing GERD (even those on medical therapy) will develop Barrett’s esophagus which is associated with increased risk of developing esophageal cancer.”

For additional information follow this link to the official statement from the FDA: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine

If you have acid reflux particularly uncontrolled symptoms or have been on medication for many years, you should speak to your Gastroenterologist (GI) about this and having an endoscopy. You can speak to your primary care provider to help obtain a referral to see a specialist if you do not have a gastroenterologist already. We are happy to help you at the Heartburn and Esophageal Disorders Center here UT Health Austin as well. Patients can reach our clinic or learn more information by calling 1-833-UT-CARES.

About the UT Health Austin

UT Health Austin, the group practice designed and managed by the faculty and staff of the Dell Medical School, focuses the expertise of a team of experienced medical professionals to deliver personalized, whole-person care of uncompromising quality. Our experienced healthcare professionals treat each patient as an individual, with unique circumstances, priorities and beliefs. Working with you, your care team creates an individualized care plan to help you reach the goals that matter most to you — in the care room, and beyond. For more information, call us at 1-833-UT-CARES or request an appointment here.