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

ObjectiveTo report a series of cases of ulceration of the oral mucosa linked to direct contact with ferrous sulfate in elderly patients.Case summaryThe 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.DiscussionOnly 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.ConclusionThe 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.

Oral medicine modification for older adults: a qualitative study of nurses

“…Modifications of ODFs are of concern for healthcare professionals as they can potentially affect therapeutic outcomes for patients and adverse events have been reported as a consequence of medicine modification. 23 24 There are numerous potential mechanisms by which ODF modifications may alter drug action and therefore, therapeutic outcomes. Administration of a portion of a dosage form, for example, half a tablet, may result in inaccurate dosing.…”

Oral drug therapy in elderly with dysphagia: between a rock and a hard place!

“…A number of APIs, including ferrous sulfate, 61 bisphosphonates, 62 potassium chloride, 63 nonsteroidal anti-inflammatory agents (NSAIDs), 64 and tetracycline, 65 have been identified as being responsible for GIT mucosal injuries. Sample endoscopic and microscopic views of GIT mucosae damaged by NSAIDs are shown in Figure 3 .…”

“…Liabeuf et al 61 reported a series of cases of ulceration of the oral mucosa linked to direct contact with ferrous sulfate in elderly patients, particularly when swallowing disorders were present, and advised that appropriate pharmaceutical formulations (eg, syrups) should be administered to at-risk patients. The mucosal damage caused by high local iron concentrations may be related to the formation of reactive oxygen species.…”

“… 69 Mouth ulcerations and necrosis have been found after administering crushed tablets containing ferrous sulfate. 61 …”

Production, iron analysis and consumer perception of functional Thai Sinlek iron rice (Oryza sativa) drink

“…However, the oxidative mucosal toxicity of ferrous sulphate tablets was found when deglutition disorders were present among elderly patients. Accordingly, appropriate iron‐fortified staple foods have been produced and tested clinically in infants to reduce the prevalence of IDA which can have a negative impact on growth, development and the quality of life of the population (Arcanjo et al ., 2008; Liabeuf et al ., 2014). Examples of the iron‐fortified foods include ferric ethylenediaminetetraacetate (FeEDTA)‐fortified cowpea flour, FeEDTA and ferrous sulphate‐fortified galacto‐oligosaccharides (Abizari et al ., 2012; Ahmad et al ., 2013).…”