Last reviewed: June 2020
Last updated: November  2019
22 Apr 2020

FDA requests withdrawal of ranitidine from the market

The Food and Drug Administration (FDA) has requested that manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately following concerns that they may contain unacceptable levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen.

In an ongoing investigation, the FDA found that NDMA increases in some ranitidine products over time, and when stored at higher than room temperatures, which may result in people being exposed to unacceptable levels. 

The FDA advises that patients taking prescription ranitidine should consult their health care provider before stopping to discuss alternative options; currently, the FDA has not found NDMA in famotidine, cimetidine, esomeprazole, lansoprazole, or omeprazole. Patients taking OTC ranitidine are advised to stop taking any they currently have and consider other approved OTC products if they wish to continue treatment.

See Management: treatment algorithm

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Summary

Definition

History and exam

Other diagnostic factors

  • dysphagia
  • bloating/early satiety
  • laryngitis
  • globus
  • enamel erosion
  • halitosis
  • dyspepsia

Risk factors

  • family history of heartburn or GERD
  • older age
  • hiatal hernia
  • obesity
  • lower esophageal sphincter (LES) tone-reducing drugs
  • psychological stress
  • asthma
  • nonsteroidal anti-inflammatory drugs (NSAIDs)
  • smoking
  • alcohol consumption
  • peroral endoscopic myotomy (POEM)
  • dietary factors

Diagnostic investigations

Investigations to consider

  • esophagogastroduodenoscopy (EGD)
  • ambulatory pH monitoring
  • esophageal manometry
  • combined impedance-pH testing
  • barium swallow
  • esophageal capsule endoscopy
More investigations to consider

Treatment algorithm

Contributors

Professor of Medicine

Chief of Division of Gastroenterology

Texas Tech University Health Sciences Center

El Paso

TX

Disclosures

MJZ has been a speaker for Synergy Pharmaceuticals and for Allergan Pharmaceuticals. He is an author of a reference cited in this topic.

Assistant Professor of Clinical Medicine

Division of Gastroenterology and Hepatology

University of Miami

Miami

FL

Disclosures

AFC declares that he has no competing interests.

Dr Marc J. Zuckerman and Dr Andres F. Carrion would like to gratefully acknowledge Dr. Sheila Feit and Dr. Mohamed Othman, previous contributors to this topic.

Peer reviewersVIEW ALL

Professor of Medicine

Chief of GI Endoscopy

Rikshospitalet University Hospital

Oslo

Norway

Disclosures

LA declares that he has no competing interests.

Consultant

Department of Internal Medicine

Copenhagen University Hospital

Hellerup

Denmark

Disclosures

LLG declares that she has no competing interests.

Professor of Medicine

Department of Gastroenterology & Hepatology

Center for Swallowing & Esophageal Disorders

Cleveland Clinic

Cleveland

OH

Disclosures

GWF has received fees from: Astra Zeneca (consultant, speakers bureau, grant support); Takeda (grant support); Pentax (speaker, travel); Wyeth (consultant); and C2 Therapeutics (consultant).

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