Oxcarbazepine

1
Reactions 1046 - 9 Apr 2005 S Oxcarbazepine First report of DRESS syndrome in a child: case report An 11-year-old girl developed drug-induced rash with eosinophilia and systemic symptoms (DRESS) failure during treatment with oxcarbazepine for epilepsy. The girl started receiving a gradually increasing dose of oxcarbazepine [Trileptal; dosage not clearly stated] and, approximately 40 days later, presented with an otorhinolaryngological infection and she received antibacterials. However, within 72 hours, her condition had deteriorated rapidly with the development of a disseminated maculoerythematous skin eruption, and she was hospitalised. On admission, the girl’s preliminary diagnosis was infectious mononucleosis, and antibacterials and oxcarbazepine were stopped. She received IV immunoglobulins, and laboratory investigations showed an elevated leucocyte count, an inflammatory syndrome with a C- reactive protein level of 116 mg/L, and transaminase levels elevated to three times the upper limit of normal. Within 48 hours, her skin eruption had developed into an erythroderma, followed by desquamation starting at her hands, and her level of consciousness changed. Within 72 hours, her transaminase levels had increased to ten times the upper limit of normal, coagulation abnormalities occurred, and she was transferred to the paediatric ICU. She was febrile, somnolent, and she had desquamation, mostly of her feet and hands. She had mucous membrane and skin jaundice and EEG revealed stage III hepatic encephalopathy. Her transaminase levels increased to 25 times the upper limit of normal, she had a factor V of 15%, a prothrombin level of 9%, and hypereosinophilia. Liver biopsy findings were consistent with a viral infection. Within 4 days, her liver function stabilised, her neurological condition improved, she became alert and was transferred to the paediatric ward. Her digestive condition improved, although jaundice persisted, and she experienced recurrent ascites requiring repeated paracentesis. Within 11 days, her liver function had normalised, except for an elevated bilirubin level of 450 mmol/L. Areas of skin depigmentation remained, and she experienced two urticaria- like skin eruption episodes. The girl received benzodiazepines, and recovered completely neurologically. Her fever persisted for 3 weeks. Thirty days after illness onset, she received 10 days’ macrolide treatment for interstitial pneumonia. Within 3 weeks, blood test results had normalised and hypereosinophilia resolved. She was diagnosed with DRESS syndrome, and was discharged after 6 weeks without sequelae. Author comment: The Pharmacovigilance Centre confirmed that implication of Trileptal was probable in this case. Bosdure E, et al. Oxcarbazepine and DRESS syndrome: a paediatric cause of acute liver failure. Archives de Pediatrie 11: 1073-1077, No. 9, Sep 2004 [French; summarised from a translation] - France 807218916 » Editorial comment: A search of AdisBase and Medline did not reveal any previous case reports of drug hypersensitivity associated with oxcarbazepine. The WHO Adverse Drug Reactions database contained seven reports of eosinophilia and 141 of rash associated with oxcarbazepine. 1 Reactions 9 Apr 2005 No. 1046 0114-9954/10/1046-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Transcript of Oxcarbazepine

Reactions 1046 - 9 Apr 2005

★ SOxcarbazepine

First report of DRESS syndrome in a child: casereport

An 11-year-old girl developed drug-induced rash witheosinophilia and systemic symptoms (DRESS) failure duringtreatment with oxcarbazepine for epilepsy.

The girl started receiving a gradually increasing dose ofoxcarbazepine [Trileptal; dosage not clearly stated] and,approximately 40 days later, presented with anotorhinolaryngological infection and she receivedantibacterials. However, within 72 hours, her condition haddeteriorated rapidly with the development of a disseminatedmaculoerythematous skin eruption, and she was hospitalised.

On admission, the girl’s preliminary diagnosis wasinfectious mononucleosis, and antibacterials andoxcarbazepine were stopped. She received IVimmunoglobulins, and laboratory investigations showed anelevated leucocyte count, an inflammatory syndrome with a C-reactive protein level of 116 mg/L, and transaminase levelselevated to three times the upper limit of normal. Within48 hours, her skin eruption had developed into anerythroderma, followed by desquamation starting at herhands, and her level of consciousness changed. Within72 hours, her transaminase levels had increased to ten timesthe upper limit of normal, coagulation abnormalities occurred,and she was transferred to the paediatric ICU. She was febrile,somnolent, and she had desquamation, mostly of her feet andhands. She had mucous membrane and skin jaundice and EEGrevealed stage III hepatic encephalopathy. Her transaminaselevels increased to 25 times the upper limit of normal, she hada factor V of 15%, a prothrombin level of 9%, andhypereosinophilia. Liver biopsy findings were consistent with aviral infection. Within 4 days, her liver function stabilised, herneurological condition improved, she became alert and wastransferred to the paediatric ward. Her digestive conditionimproved, although jaundice persisted, and she experiencedrecurrent ascites requiring repeated paracentesis. Within11 days, her liver function had normalised, except for anelevated bilirubin level of 450 mmol/L. Areas of skindepigmentation remained, and she experienced two urticaria-like skin eruption episodes.

The girl received benzodiazepines, and recoveredcompletely neurologically. Her fever persisted for 3 weeks.Thirty days after illness onset, she received 10 days’ macrolidetreatment for interstitial pneumonia. Within 3 weeks, bloodtest results had normalised and hypereosinophilia resolved.She was diagnosed with DRESS syndrome, and was dischargedafter 6 weeks without sequelae.

Author comment: The Pharmacovigilance Centreconfirmed that implication of Trileptal was probable in thiscase.Bosdure E, et al. Oxcarbazepine and DRESS syndrome: a paediatric cause of acuteliver failure. Archives de Pediatrie 11: 1073-1077, No. 9, Sep 2004 [French;summarised from a translation] - France 807218916

» Editorial comment: A search of AdisBase and Medline didnot reveal any previous case reports of drug hypersensitivityassociated with oxcarbazepine. The WHO Adverse DrugReactions database contained seven reports of eosinophilia and141 of rash associated with oxcarbazepine.

1

Reactions 9 Apr 2005 No. 10460114-9954/10/1046-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved