Last reviewed: July 2020
Last updated: November  2019
26 May 2020

EMA suspends ranitidine in Europe

The European Medicines Agency's (EMA's) human medicines committee has recommended the suspension of all medicines that contain ranitidine in Europe due to the presence of low, but unacceptable, levels of an impurity called N-nitrosodimethylamine (NDMA), a probable human carcinogen. Patients should be switched to an alternative medication.

Although the exact source of the impurity is yet to be determined, it is possible that it may form from the degradation of ranitidine even under normal storage conditions. Available clinical and epidemiological data do not show that ranitidine increases the risk of cancer. 

The US Food and Drug Administration also removed ranitidine from the US market last month. 

See Management: treatment algorithm

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Summary

Definition

History and exam

Key diagnostic factors

  • presence of risk factors
  • heartburn
  • acid regurgitation

Other diagnostic factors

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

Risk factors

  • family history of heartburn or GORD
  • older age
  • hiatus hernia
  • obesity
  • lower oesophageal sphincter (LOS) tone-reducing drugs
  • psychological stress
  • asthma
  • non-steroidal anti-inflammatory drugs (NSAIDs)
  • smoking
  • alcohol consumption
  • per-oral endoscopic myotomy (POEM)
  • dietary factors

Diagnostic investigations

Investigations to consider

  • oesophagogastroduodenoscopy (OGD)
  • ambulatory pH monitoring
  • oesophageal manometry
  • combined impedance-pH testing
  • barium swallow
  • oesophageal 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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