Pub Date : 2015-12-29DOI: 10.1007/s40800-015-0024-2
S. Cham, H. J. Koslik, B. Golomb
{"title":"Mood, Personality, and Behavior Changes During Treatment with Statins: A Case Series","authors":"S. Cham, H. J. Koslik, B. Golomb","doi":"10.1007/s40800-015-0024-2","DOIUrl":"https://doi.org/10.1007/s40800-015-0024-2","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81334001","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}
Pub Date : 2015-12-01DOI: 10.1007/S40800-015-0016-2
F. Hunsel, S. Koppel, E. Puijenbroek
{"title":"Post-Menopausal Vaginal Hemorrhage Related to the Use of a Hop-Containing Phytotherapeutic Product","authors":"F. Hunsel, S. Koppel, E. Puijenbroek","doi":"10.1007/S40800-015-0016-2","DOIUrl":"https://doi.org/10.1007/S40800-015-0016-2","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89544467","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}
Pub Date : 2015-12-01DOI: 10.1007/s40800-015-0018-0
Katherine J Hahn, Shannon J Morales, James H Lewis
Anticoagulants are a well known cause of drug-induced liver injury (DILI). We recently encountered a 45-year-old male who developed DILI during treatment with enoxaparin, a low-molecular-weight heparin (LMWH), for dural venous thrombosis. The man received enoxaparin 80 mg subcutaneously, twice daily. After 4 days, the patient was asymptomatic but he developed liver aminotransferase elevations: AST 340 U/L and ALT 579 U/L. Investigation revealed an R ratio of 19.9 by day 5 and a Roussel Uclaf Causality Assessment Method score of 10, giving a high probable likelihood that enoxaparin was the cause of hepatic injury. Enoxaparin was discontinued on day 7, and 1 week later AST and ALT had decreased to 61 and 273 U/L, respectively. This case prompted a literature search and a review of the FDA Adverse Event Reporting System (FAERS) database for the range of hepatic adverse events (HAEs) associated with this class. A MEDLINE/PubMed search was conducted using DILI terms and cross-referenced with the anticoagulant classes. A Freedom of Information Act (FOIA) request was also made to identify adverse events (AEs) associated with enoxaparin in FAERS. Case type, severity of outcome, and demographic information were analyzed. Five publications have reported DILI with enoxaparin. Trial data found elevations in ALT >3 times the upper limit of normal (ULN) for unfractionated heparins (UFH) and LMWH in 8 and 4-13 % of subjects, respectively. However, liver injury in all cases was mild, self-limited, and asymptomatic. Our FOIA request yielded 8336 adverse events related to enoxaparin over a 14-year period (Jan 2000-Sept 2014). Specific HAEs were found in 4 % of reports, but all were described with other serious adverse events. The reported outcomes of hospitalization (75 %), death (17 %), and life-threatening medical events (5 %) were likely due to other related serious adverse events such as hemorrhage (28 %) and thrombocytopenia (11 %). We conclude that LMWH-related liver injury is uncommon and reversible. The mechanism of liver injury is not known, although an idiosyncratic effect is postulated. Although the FAERS database lists hepatic injury in 4 % of all enoxaparin-related AEs, it appears that serious outcomes are related to non-hepatic events.
{"title":"Enoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA Adverse Event Reporting System (FAERS).","authors":"Katherine J Hahn, Shannon J Morales, James H Lewis","doi":"10.1007/s40800-015-0018-0","DOIUrl":"10.1007/s40800-015-0018-0","url":null,"abstract":"<p><p>Anticoagulants are a well known cause of drug-induced liver injury (DILI). We recently encountered a 45-year-old male who developed DILI during treatment with enoxaparin, a low-molecular-weight heparin (LMWH), for dural venous thrombosis. The man received enoxaparin 80 mg subcutaneously, twice daily. After 4 days, the patient was asymptomatic but he developed liver aminotransferase elevations: AST 340 U/L and ALT 579 U/L. Investigation revealed an R ratio of 19.9 by day 5 and a Roussel Uclaf Causality Assessment Method score of 10, giving a high probable likelihood that enoxaparin was the cause of hepatic injury. Enoxaparin was discontinued on day 7, and 1 week later AST and ALT had decreased to 61 and 273 U/L, respectively. This case prompted a literature search and a review of the FDA Adverse Event Reporting System (FAERS) database for the range of hepatic adverse events (HAEs) associated with this class. A MEDLINE/PubMed search was conducted using DILI terms and cross-referenced with the anticoagulant classes. A Freedom of Information Act (FOIA) request was also made to identify adverse events (AEs) associated with enoxaparin in FAERS. Case type, severity of outcome, and demographic information were analyzed. Five publications have reported DILI with enoxaparin. Trial data found elevations in ALT >3 times the upper limit of normal (ULN) for unfractionated heparins (UFH) and LMWH in 8 and 4-13 % of subjects, respectively. However, liver injury in all cases was mild, self-limited, and asymptomatic. Our FOIA request yielded 8336 adverse events related to enoxaparin over a 14-year period (Jan 2000-Sept 2014). Specific HAEs were found in 4 % of reports, but all were described with other serious adverse events. The reported outcomes of hospitalization (75 %), death (17 %), and life-threatening medical events (5 %) were likely due to other related serious adverse events such as hemorrhage (28 %) and thrombocytopenia (11 %). We conclude that LMWH-related liver injury is uncommon and reversible. The mechanism of liver injury is not known, although an idiosyncratic effect is postulated. Although the FAERS database lists hepatic injury in 4 % of all enoxaparin-related AEs, it appears that serious outcomes are related to non-hepatic events.</p>","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5005670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88440675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-12-01DOI: 10.1007/s40800-015-0023-3
A. Tafazoli
{"title":"Accidental Overdose of Oral Cyclosporine in Haematopoietic Stem Cell Transplantation: A Case Report and Literature Review","authors":"A. Tafazoli","doi":"10.1007/s40800-015-0023-3","DOIUrl":"https://doi.org/10.1007/s40800-015-0023-3","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74280634","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}
Pub Date : 2015-11-23DOI: 10.1007/s40800-015-0021-5
Huimin Lin, S. Chew
{"title":"Status Epilepticus and Delirium Associated with Ertapenem in a Very Elderly Patient with Chronic Kidney Disease and Silent Ischaemic Cerebrovascular Disease","authors":"Huimin Lin, S. Chew","doi":"10.1007/s40800-015-0021-5","DOIUrl":"https://doi.org/10.1007/s40800-015-0021-5","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83042460","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}
Pub Date : 2015-11-05DOI: 10.1007/s40800-015-0020-6
Yi-Chia Su, Chih-Chien Wu
{"title":"Colchicine-Induced Acute Neuromyopathy in a Patient Using Concomitant Fluconazole: Case Report and Literature Review","authors":"Yi-Chia Su, Chih-Chien Wu","doi":"10.1007/s40800-015-0020-6","DOIUrl":"https://doi.org/10.1007/s40800-015-0020-6","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86144687","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}
Pub Date : 2015-09-24DOI: 10.1007/s40800-015-0019-z
Sabyasachi Paik, Agnik Pal, S. Sen, Netai Pramanick, S. Tripathi
{"title":"A Suspected Case of Efavirenz-Induced Stevens–Johnson Syndrome","authors":"Sabyasachi Paik, Agnik Pal, S. Sen, Netai Pramanick, S. Tripathi","doi":"10.1007/s40800-015-0019-z","DOIUrl":"https://doi.org/10.1007/s40800-015-0019-z","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74258441","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}
Pub Date : 2015-08-28DOI: 10.1007/s40800-015-0015-3
J. Alexandre, X. Humbert, M. Sassier, P. Milliez, A. Coquerel, S. Fédrizzi
{"title":"High-Dose Verapamil in Episodic and Chronic Cluster Headaches and Cardiac Adverse Events: Is It as Safe as We Think?","authors":"J. Alexandre, X. Humbert, M. Sassier, P. Milliez, A. Coquerel, S. Fédrizzi","doi":"10.1007/s40800-015-0015-3","DOIUrl":"https://doi.org/10.1007/s40800-015-0015-3","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74173444","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}
Pub Date : 2015-08-01DOI: 10.1007/s40800-015-0013-5
F. Vincenzi, P. Lunetta
{"title":"Citalopram-Induced Long QT Syndrome and the Mammalian Dive Reflex","authors":"F. Vincenzi, P. Lunetta","doi":"10.1007/s40800-015-0013-5","DOIUrl":"https://doi.org/10.1007/s40800-015-0013-5","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72883165","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}
Pub Date : 2015-08-01DOI: 10.1007/s40800-015-0014-4
C. Corallo, Louise Grannell, Huyen A Tran
{"title":"Postoperative Bleeding After Administration of a Single Dose of Rivaroxaban to a Patient Receiving Antiretroviral Therapy","authors":"C. Corallo, Louise Grannell, Huyen A Tran","doi":"10.1007/s40800-015-0014-4","DOIUrl":"https://doi.org/10.1007/s40800-015-0014-4","url":null,"abstract":"","PeriodicalId":11364,"journal":{"name":"Drug Safety - Case Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2015-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79148343","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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