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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

Authors Liabeuf S, Gras V, Moragny J, Laroche M, Andrejak M

Received 27 November 2013

Accepted for publication 20 January 2014

Published 25 April 2014 Volume 2014:9 Pages 737—740


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Sophie Liabeuf,1–3 Valérie Gras,1 Julien Moragny,1 Marie-Laure Laroche,4 Michel Andrejak1,3

On behalf of the French National Network of Pharmacovigilance Centers

1Regional Pharmacovigilance Center, Division of Clinical Pharmacology, Amiens University Medical Center and Jules Verne University of Picardy, Amiens, France; 2Clinical Research Centre, Clinical Pharmacology Division, Amiens University Medical Center and the Jules Verne University of Picardy, Amiens, France; 3INSERM U1088, Amiens, France; 4Regional Pharmacovigilance Center, Department of Pharmacology, Toxicology and Pharmacovigilance, Limoges University Medical Center, Limoges, France

Objective: To report a series of cases of ulceration of the oral mucosa linked to direct contact with ferrous sulfate in elderly patients.
Case summary: 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.
Discussion: 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.
Conclusion: 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.

ferrous sulfate, drug ulceration, oral ulceration, elderly

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