Fondaparinux (Arixtra∗) hepatotoxicity in a 6 year-old child

Orostegui, Lupe; Médejel, Nadia; Koné‐Paut, Isabelle; Dreyfus, Marie; Benhamou, Dan

doi:10.1016/j.jhep.2012.09.015

Cited by 5 publications

(4 citation statements)

References 8 publications

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“…15,16 The hepatotoxicity of fondaparinux sodium is characterized by elevated ALT/AST levels, rare elevation of bilirubin, and mostly without clinical symptoms, which could return to normal spontaneously. 17 However, Orostegui et al 18 noticed that a child developed nausea and vomiting with increased AST, ALT, and GGT after a 2-day administration of fondaparinux sodium for upper limb thrombosis, and the liver function returned to normal after adjustment to enoxaparin sodium. Therefore, it is worthwhile to note that enoxaparin sodium, nadroparin calcium, and fondaparinux sodium might cause mild liver dysfunction during the clinical application.…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Effects of Low‐Molecular‐Weight Heparin and Fondaparinux on Liver Function in Patients With Pulmonary Embolism

Yang

Guo

et al. 2020

The Journal of Clinical Pharma

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Hepatotoxicity with low-molecular-weight heparin (LMWH) or fondaparinux is a relatively common adverse reaction. This study assessed the effects of LMWH and fondaparinux on liver function in patients with pulmonary embolism based on a retrospective cohort. As a result, a total of 463 patients with pulmonary embolism and treated with LMWH (enoxaparin sodium or nadroparin calcium) or fondaparinux sodium were included. Liver dysfunction was identified in 79 patients (17.1%), of whom 97.5% had grade 1 drug-induced liver injury (DILI) and 2.5% had grade 2 DILI. The results showed that liver dysfunction usually occurred in the first week after anticoagulant administration, and the liver tests of all patients with liver dysfunction gradually recovered or alleviated at discharge. The multivariable logistic regression analysis indicated that a longer treatment course and hepatitis B surface antigen-positive (HBsAg+) were risk factors for liver dysfunction (P < .05). Moreover, nadroparin calcium had the highest risk of liver dysfunction, approximately 2.2 times (95% confidence interval [CI], 1.1740-4.224; P = .015) that of enoxaparin sodium. In conclusion, nearly one-fifth and 10% of patients prescribed with LMWH or fondaparinux, respectively, for pulmonary embolism had liver dysfunction, mainly with mild liver injury and characterized by self-limited elevated serum transaminase levels. Hence, during the 3 anticoagulant applications, we should pay more attention to the monitoring of liver function in the first week and transit to oral anticoagulants if possible, especially for patients who are HBsAg+ or suffering from other liver diseases.

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Section: Discussionmentioning

confidence: 99%

Comparison of the Effects of Low‐Molecular‐Weight Heparin and Fondaparinux on Liver Function in Patients With Pulmonary Embolism

Yang

Guo

et al. 2020

The Journal of Clinical Pharma

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“…A total of 3 published abstracts, one letter to the editor, 5 case reports, and 1 study, representing a total of 36 children ranging from 2 months to 18 years of age, provide a description of fondaparinux for treatment of thrombosis and/or HIT. [7][8][9][10][11][12][13][14][15] The initial dosing in the case reports ranged from 0.05 to 0.25 mg/ kg/dose SQ daily. In these reports, pharmacokinetic monitoring with anti-factor Xa assay was conducted, although there was significant variability in the goal therapeutic range.…”

Section: Discussionmentioning

confidence: 99%

“…1 To date, there are limited data available on the safety and efficacy of fondaparinux in children. [7][8][9][10][11][12][13][14][15] Fondaparinux, like LMWH agents, usually does not need to be monitored except in special populations (e.g., patients with obesity or renal failure and children). The ACCP provides limited recommendations for monitoring in adults, as the therapeutic anti-factor Xa range for fondaparinux has not been determined.…”

Section: Introductionmentioning

confidence: 99%

Fondaparinux in an Obese Child with Heparin-Induced Thrombocytopenia and a History of Renal Failure

Johnson

Benefield

Bui

et al. 2013

The Journal of Pediatric Pharmacology and Therapeutics

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A 9-year-old obese child with a history of ulcerative colitis was admitted to the intensive care unit for significant blood loss, hemorrhagic shock, and acute renal failure. Following complications from total colectomy secondary to multiple perforations, the patient developed heparin-induced thrombocytopenia (HIT) and subsequent portal vein thrombosis. Subcutaneous (SQ) fondaparinux therapy was initiated because the patient was unable to transition to oral anticoagulation. An anti-factor Xa assay was developed and used to adjust his fondaparinux therapy. Based on hemorrhagic complications and fondaparinux-based anti-factor Xa assay results, the fondaparinux was adjusted to a final dosage of 4.5 mg (0.066 mg/kg) SQ daily. In children unable to transition to oral anticoagulation, fondaparinux may be an alternative for the treatment of thrombosis associated with HIT. We noted that our patient required a lower dose per kilogram of fondaparinux than described in previous published reports. Despite this lower dosage per kilogram, our patient developed bleeding despite dosage reductions; subsequently, a few doses were held. It is unclear if this was related to his obesity, history of renal failure, or a combination of factors. Future studies should determine the optimal dose for special populations of children (e.g., those with obesity and renal failure). Until then, clinicians should routinely monitor and titrate fondaparinux therapy, ideally using a fondaparinux-specific anti-factor Xa assay.

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“…In the last decade, DILI in children has been described in case reports or small series. 4 – 7 A recent prospective study over more than 5 years from Drug-Induced Liver Injury Network (DILIN) has reported the clinical and pathological characteristics of 30 children with DILI. 8 Compared with adults, drug metabolism in children differs in terms of absorption, distribution, metabolism, and excretion.…”

Section: Introductionmentioning

confidence: 99%

Causes, Features, and Outcomes of Drug-Induced Liver Injury in 69 Children from China

Zhu

Wang

et al. 2015

Gut Liver

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Background/AimsDrug-induced liver injury (DILI) is a frequent cause of pediatric liver disease; however, the data on DILI are remarkably limited.MethodsAll 69 children hospitalized with DILI between January 2009 and December 2011 were retrospectively studied.ResultsA total of 37.7% of the children had medical histories of respiratory infection. The clinical injury patterns were as follows: hepatocellular 89.9%, cholestatic 2.9%, and mixed 7.2%. Liver biopsies from 55 children most frequently demonstrated chronic (47.3%) and acute (27.3%) hepatitis. Hypersensitivity features, namely, fever (31.9%), rash (21.7%), and eosinophilia (1.4%), were found. Twenty-four children (34.8%) developed chronic DILI. Antibiotics (26.1%) were the most common Western medicines (WMs) causing DILI, and the major implicated herbs were Ephedra sinica and Polygonum multiflorum. Compared with WM, the children whose injuries were caused by Chinese herbal medicine (CHM) showed a higher level of total bilirubin (1.4 mg/dL vs 16.6 mg/dL, p=0.004) and a longer prothrombin time (11.8 seconds vs 17.3 seconds, p=0.012), but they exhibited less chronic DILI (2/15 vs 18/39, p=0.031).ConclusionsMost cases of DILI in children are caused by antibiotics or CHM used to treat respiratory infection and present with hepatocellular injury. Compared with WM, CHM is more likely to cause severe liver injury, but liver injury caused by CHM is curable.

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Fondaparinux (Arixtra∗) hepatotoxicity in a 6 year-old child

Cited by 5 publications

References 8 publications

Comparison of the Effects of Low‐Molecular‐Weight Heparin and Fondaparinux on Liver Function in Patients With Pulmonary Embolism

Comparison of the Effects of Low‐Molecular‐Weight Heparin and Fondaparinux on Liver Function in Patients With Pulmonary Embolism

Fondaparinux in an Obese Child with Heparin-Induced Thrombocytopenia and a History of Renal Failure

Causes, Features, and Outcomes of Drug-Induced Liver Injury in 69 Children from China

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