Clin-Alert®Pub Date : 2016-07-01DOI: 10.1177/0069477016659717
{"title":"Reporting on Adverse Clinical Events","authors":"","doi":"10.1177/0069477016659717","DOIUrl":"https://doi.org/10.1177/0069477016659717","url":null,"abstract":"A 16-year-old male developed elevated aminotransferases, hepatic synthetic dysfunction, and symptoms of encephalopathy including fatigue, lethargy, and mental status changes 5 days after initiating anakinra (500 mg subcutaneously twice daily) for the treatment of adult-onset Still’s disease. Concurrent medications included intravenous methylprednisolone (500 mg for 1 day and 100 mg daily thereafter) and oral naproxen (500 mg twice daily). Liver ultrasound revealed hepatosplenomegaly with normal liver echotexture and patent vessels. Laboratory analysis revealed increased aspartate aminotransferase (peak = 2271 units/L), alanine aminotransferase (peak = 2002 units/L), direct bilirubin (peak = 1.7 mg/ dL), and international normalized ratio (peak = 1.71). Bone marrow biopsy was negative for macrophage activation syndrome. Further analyses revealed no evidence of infection or autoimmune hepatitis. Liver biopsy was consistent with acute hepatitis in the setting of drug-induced liver injury. Initial treatment included reduction of anakinra dose (100 mg daily) 5 days after initiation, and subsequent discontinuation due to concern for drug-induced liver injury. Further treatment included supportive care for acute liver failure, and treatment for adult-onset Still’s disease was changed to oral prednisone (40 mg twice daily) and oral cyclosporine (200 mg twice daily). Aminotransferase levels normalized within 1 month after withdrawal of anakinra. Full recovery and normal aminotransferase levels were maintained at assessment 1 year later. The authors concluded that the acute liver injury described in this case had a probable association with anakinra administration as assessed via the Naranjo criteria. The proposed mechanism was a heterogeneous response to interleukin-1 receptor antagonism induced by anakinra. Anakinra [“Kineret”] Taylor SA et al (SA Taylor, Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Lurie Children’s Hospital of Chicago, 225 E Chicago Ave, Box 65, Chicago, IL 60611-2605; e-mail: sataylor@ luriechildrens.org) Anakinra-induced acute liver failure in an adolescent patient with Still’s disease. Pharmacotherapy 36:e1–e4 (Jan) 2016","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"70 1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128812004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clin-Alert®Pub Date : 2016-05-01DOI: 10.1177/0069477016649867
{"title":"Reporting on Adverse Clinical Events","authors":"","doi":"10.1177/0069477016649867","DOIUrl":"https://doi.org/10.1177/0069477016649867","url":null,"abstract":"A 79-year-old female patient developed localized skin lesions with itchy papules and vesicles on the cheek approximately 64 days after the initiation of afatinib for the treatment of metastatic non–small cell lung cancer. Concurrent medication included levothyroxine, cholecalciferol, valsartan, and nebivolol. Symptoms progressed to diffuse papules and vesicles, which evolved into atypical targetoid maculae on the trunk and eventually to flaccid bullae. Additional symptoms included oral ulcers, conjunctivitis, diffuse alopecia, and development of taste loss. Stevens-Johnson syndrome was diagnosed. Treatment included the discontinuation of afatinib and the administration of oral steroids (1 mg/kg/day), topical steroids, piperacillin/tazobactam, and desloratadine. Treatment was not successful in improving the patient’s condition. Serological testing for other causes was negative. A skin biopsy revealed acute interface dermatitis. Clinical symptoms and skin lesions slowly improved over a 20-day period with eventual recovery approximately 2 months after the drug was stopped. The authors concluded that this patient experienced Stevens-Johnson syndrome related to the administration of afatinib due to the temporal relationship between the administration of the drug and the appearance and resolution of symptoms. They cautioned clinicians to be aware of this potential adverse event associated with the drug. Afatinib [“Gilotrif”] Doesch J et al (W Brueckl, Department of Respiratory Medicine, Allergology and Sleep Medicine, Paracelsus Medical University, General Hospital Nuernberg Prof.-Ernst-Nathan-Str 1, 90410 Nuremberg, Germany; e-mail: Wolfgang.brueckl@klinikum-nuernberg.de) Afatinib-associated Stevens-Johnson syndrome in an EGFR-mutated lung cancer patient. Lung Cancer 95:35–38 (May) 2016","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131147945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Clin-Alert®Pub Date : 2016-03-01DOI: 10.1177/0069477016639225
T. Mcevoy
{"title":"Reporting on Adverse Clinical Events","authors":"T. Mcevoy","doi":"10.1177/0069477016639225","DOIUrl":"https://doi.org/10.1177/0069477016639225","url":null,"abstract":"The effect of St John’s Wort on glucose tolerance (assessed by an oral glucose tolerance test) was evaluated in 10 healthy men (median age = 26 years) with normal blood glucose. The study consisted of 3 different phases: (a) baseline prior to St John’s Wort; (b) after 21 days treatment with St John’s Wort; and (c) at least 6 weeks after St John’s Wort was stopped. The subjects fasted for 12 hours and ingested 75 g glucose in 250 mL of water. Blood samples were drawn at 0, 15, 30, 45, 60, 90, and 120 minutes and analyzed for plasma glucose, serum insulin, and C-peptide concentrations. There was a median of 48 days (range = 22-78) between phases A and B and a median of 48 days (range = 38-94) between phases B and C. The fasting levels of plasma glucose, serum insulin, and C-peptide did not differ between the 3 phases. The total glucose area under the curve was increased (18%) during St John’s Wort treatment with St John’s Wort and by an additional 17% at least 6 weeks after therapy was stopped. The incremental glucose area under the curve increased by 48% and 31% for the same time periods, respectively. The 2-hour glucose increased by approximately 40% from baseline to phases B and C. No changes in insulin clearance occurred. The authors concluded that, in this preliminary study, St John’s Wort impairs glucose tolerance in healthy subjects, most likely mediated by decreased insulin secretion. They also suggested that further studies are required to confirm these results. St John’s Wort [St John’s Wort] Stage TB et al (TB Stage, Clinical Pharmacology, Department of Public Health, University of Southern Denmark, JB Winsloews Vej 19, 2, DK-5000 Odense C, Denmark; e-mail: tstage@health.sdu.dk) Impaired glucose tolerance in healthy men treated with St. John’s Wort. Basic Clin Pharmacol Toxicol 118:219–224 (Mar) 2016","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125832418","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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