Reporting on Adverse Clinical Events

J. Dill, T. Mcevoy
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Abstract

An 80-year-old Caucasian male patient developed worsening confusion, irritability, delusions, persecution, and slurred speech approximately 3 weeks after starting melatonin (1 mg daily). Concurrent medications included enalapril, atenolol, chlortalidone, gliclazide, esomeprazole, atorvastatin, dutasteride, and silodosin. No other herbal-type medications were ingested. On admission, abnormal laboratory tests included a decreased serum sodium level (110 mEq/L). Other laboratory levels were in normal. Hematological and urinary screenings for infectious etiologies were negative. Based on these results, both melatonin and chlortalidone were discontinued. Treatment was initiated with hypertonic saline (3%), haloperidol, and sodium valproate. Symptoms gradually resolved over several days and was associated with normalization of serum sodium levels. By the fourth day serum sodium levels were within normal levels. At a 2-month follow-up assessment, chlorthalidone was reinitiated with no further events noted; serum sodium and other electrolytes were within normal limits. Rechallenge with melatonin was not performed. The patient was advised to not restart melatonin therapy. Based on the results of this case report, the author concluded that this patient experienced syndrome of inappropriate antidiuretic hormone related to melatonin therapy based on the temporal relationship between the administration of the product and the onset of symptoms. Melatonin [Melatonin] Famularo G (G Famularo, San Camillo Hospital, Rome, Italy) Syndrome of inappropriate antidiuretic hormone secretion in a patient treated with melatonin. Ann Pharmacother 55:131-132 (Jan) 2021
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不良临床事件报告
一位80岁的白人男性患者在开始使用褪黑素(每日1mg)约3周后出现了日益恶化的精神错乱、易怒、妄想、迫害和言语不清。同时使用的药物包括依那普利、阿替洛尔、氯他酮、格列齐特、埃索美拉唑、阿托伐他汀、杜他雄胺和西洛多辛。没有摄入其他草药类药物。入院时,实验室检查异常包括血清钠水平下降(110 mEq/L)。其他实验室水平正常。血液学和泌尿学感染病因筛查均为阴性。基于这些结果,褪黑激素和氯他酮都被停用。治疗开始时使用高渗盐水(3%)、氟哌啶醇和丙戊酸钠。几天后症状逐渐消退,血清钠水平恢复正常。到第四天,血清钠水平在正常范围内。在2个月的随访评估中,氯噻酮重新开始使用,没有发现进一步的事件;血清钠及其他电解质在正常范围内。未进行褪黑素再挑战。建议患者不要重新开始褪黑素治疗。根据本病例报告的结果,作者根据服用产品与症状发作的时间关系得出结论,该患者经历了与褪黑激素治疗相关的抗利尿激素不适当综合征。褪黑素[褪黑素]Famularo G (G Famularo,圣卡米洛医院,罗马,意大利)患者接受褪黑素治疗后抗利尿激素分泌不当的综合征。Ann Pharmacother 55:31 -132 (Jan) 2021
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Reporting on Adverse Clinical Events Reporting on Adverse Clinical Events Reporting on Adverse Clinical Events Reporting on Adverse Clinical Events Reporting on Adverse Clinical Events
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