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.
Regional Pharmacovigilance Center, Division of Clinical Pharmacology, Amiens University Medical Center and Jules Verne University of Picardy, Amiens, France.
Clin Interv Aging. 2014 Apr 25;9:737-40. doi: 10.2147/CIA.S58394. eCollection 2014.
To report a series of cases of ulceration of the oral mucosa linked to direct contact with ferrous sulfate in elderly patients.
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.
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.
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.
报告一系列与老年患者直接接触硫酸亚铁有关的口腔黏膜溃疡病例。
首例报告涉及一位患有阿尔茨海默病的 87 岁女性广泛发生口腔溃疡。溃疡从舌侧延伸到口腔底部。未找到明确的解释,各种局部治疗均无效。一旦发现硫酸亚铁片(作为铁补充剂给予)在给药前被压碎(由于患者吞咽障碍),停止这种治疗导致溃疡迅速愈合。在法国国家药物警戒数据库中还发现了其他 9 例与硫酸亚铁相关的口腔溃疡病例。除了一名患者之外,所有患者的年龄都在 80 岁以上,最年轻的患者(54 岁)患有与面瘫相关的吞咽困难。
迄今为止,仅报道了另外两例因硫酸亚铁引起的口腔溃疡。硫酸亚铁的黏膜毒性(可能与氧化应激有关)以前曾报道过下咽、食管腔和(吸入片剂后)气管支气管树。
当存在吞咽障碍(如老年患者)时,应考虑硫酸亚铁的黏膜毒性,并应向有风险的患者给予适当的药物制剂(如糖浆)。可以考虑使用除硫酸亚铁以外的铁盐。