title: Ulceration of the oral mucosa following direct contact with ferrous sulfate in elderly patients: a case report and a review of the French National Pharmacovigilance Database.
abstract: OBJECTIVE
  To report a series of cases of ulceration of the oral mucosa linked to direct contact with ferrous sulfate in elderly patients.
  
  
  METHODS
  The first case report concerns the occurrence of widespread oral ulceration in an 87-year-old woman with Alzheimer's disease. The ulceration extended from the side of the tongue to the floor of the mouth. No clear explanation was found and various local treatments were ineffective. Once it was realized that the ferrous sulfate tablets (given as an iron supplement) were crushed prior to administration (due to the patient's deglutition disorder), withdrawal of this treatment led to rapid resolution of the ulceration. Nine other cases of oral ulcerations associated with ferrous sulfate were identified in the French National Pharmacovigilance Database. All but one of the patients were over 80 years of age and the youngest patient (a 54-year-old) had dysphagia associated with facial paralysis.
  
  
  CONCLUSIONS
  Only two other reports of oral ulceration due to ferrous sulfate have been published to date. Mucosal toxicity of ferrous sulfate (which is probably related to oxidative stress) has previously been reported for the hypopharynx, the esophageal lumen, and (after inhalation of a tablet) the tracheobronchial tree.
  
  
  CONCLUSIONS
  The mucosal toxicity of ferrous sulfate must be taken into account when deglutition disorders are present (as in elderly patients) and appropriate pharmaceutical formulations (such as syrups) should be administered to at-risk patients. The use of iron salts other than ferrous sulfate could be considered.
authors.affiliation: Regional Pharmacovigilance Center, Division of Clinical Pharmacology, Amiens University Medical Center and Jules Verne University of Picardy, Amiens, France ; Clinical Research Centre, Clinical Pharmacology Division, Amiens UniversityMedical Center and the Jules Verne University of Picardy, Amiens, France ; INSERM U1088, Amiens, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Liabeuf
authors.affiliation: Regional Pharmacovigilance Center, Division of Clinical Pharmacology, Amiens University Medical Center and Jules Verne University of Picardy, Amiens, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Gras
authors.affiliation: Regional Pharmacovigilance Center, Division of Clinical Pharmacology, Amiens University Medical Center and Jules Verne University of Picardy, Amiens, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Moragny
authors.affiliation: Regional Pharmacovigilance Center, Department of Pharmacology, Toxicology and Pharmacovigilance, Limoges University Medical Center, Limoges, France.
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Laroche
authors.affiliation: Regional Pharmacovigilance Center, Division of Clinical Pharmacology, Amiens University Medical Center and Jules Verne University of Picardy, Amiens, France ; INSERM U1088, Amiens, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Andrejak
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications; D016208:Databases, Factual; D019587:Dietary Supplements / Q000009:adverse effects; D005260:Female; D005296:Ferrous Compounds / Q000009:adverse effects*; D005602:France / Q000453:epidemiology; D006801:Humans; D009061:Mouth Mucosa / Q000187:drug effects*; D019226:Oral Ulcer / Q000139:chemically induced* / Q000150:complications; D013607:Tablets
chemical_list: D005296:Ferrous Compounds; D013607:Tablets; C020748:ferrous sulfate
keywords: drug ulceration; elderly; ferrous sulfate; oral ulceration