Reactions 1704, p263 - 2 Jun 2018 » Editorial comment: This article was previously processed as newsletter. For details [see Reactions 1701 p2; 803319084]. O X S Various toxicities: 14 case reports A signal based on the information derived from VigiBase described 14 patients (nine male and five female), aged 21 74 years [ages of two patients not stated], who developed various toxicities with multiple drugs [routes not stated; not all dosages, indications, duration of treatments to reactions onsets and outcomes stated]. The patients received treatment with quetiapine – – 50mg 950mg per day and valproic acid 1.5mg 2500mg per day (10 patients). Twelve of these 14 patients also received treatment with venlafaxine, paliperidone, pipamperone, lithium, perazine, lorazepam, sertraline, nifedipine, fluvoxamine or aripiprazole. The patients developed neuroleptic malignant syndrome, rhabdomyolysis, renal failure acute, acidosis metabolic, hypotension, extrapyramidal disorder, fever, and disorientation due to quetiapine and valproic acid interaction (n=1), depressed level of consciousness, extrapyramidal disorder and hypernatraemia due to quetiapine and valproic acid interaction, and diabetes insipidus due to lithium (n=1), depressed level of consciousness, parkinsonism, coma, blood thyroid stimulating hormone decreased and altered state of consciousness (n=1) due to an interaction between quetiapine, valproic acid and aripiprazole, depressed level of consciousness and restlessness due to quetiapine prescribed overdose with valproic acid and perazine as co-suspects (n=1), depressed level of consciousness, pneumonia, pyrexia, affect lability and somnolence due to quetiapine overdose with inappropriate schedule of drug administration and valproic acid as a co- suspect (n=1), depressed level of consciousness, gait disturbance, pain, physical assault and speech disorder due to off-label use of quetiapine for depression and valproic acid as a co-suspect (n=1), rhabdomyolysis due to quetiapine, valproic acid and venlafaxine (n=1), bronchopneumonia, rhabdomyolysis and renal failure acute secondary to quetiapine, valproic acid and paliperidone (n=1), neuroleptic malignant syndrome, rhabdomyolysis, renal failure acute, acidosis metabolic, hypotension and extrapyramidal disorder because of quetiapine, valproic acid and pipamperone (n=1), dehydration, depressed level of consciousness and coma due to quetiapine, valproic acid and lorazepam (n=1), convulsions and coma secondary to quetiapine, valproic acid and sertraline (n=1), hypotension and coma secondary to quetiapine, valproic acid and nifedipine (n=1), disorientation because of quetiapine, valproic acid and lithium (n=1) or thinking abnormal, concentration impaired, disorientation, dizziness and nausea due to quetiapine, valproic acid and fluvoxamine (n=1). The time to onset of coma, depressed level of consciousness, rhabdomyolysis and disorientation ranged 1 day 3 years. The quetiapine and valproic acid combination therapy was discontinued in four of these 14 patients, the quetiapine and valproic acid doses were reduced in three patients, and valproic acid or quetiapine were stopped in two patients. The valproic acid or quetiapine therapy was re-challenged in two of these 14 patients. The coma, depressed level of consciousness, rhabdomyolysis and disorientation resolved in nine of these 14 patients. Author comment: "The resulting series of 20 cases was assessed: at least six cases had been reported in the literature, there were more male than female rhabdomyolysis patients (4:1), and quetiapine raised plasma concentrations hinted at a valproic acid-mediated pharmacokinetic interaction." The assessed case series features musculoskeletal and psychiatric events that occurred after dose increases of quetiapine, or where the reporter suspected a pharmacokinetic interaction." Sartori D, et al. Quetiapine and valproic acid interactions: signal strengthening WHO Pharmaceuticals Newsletter 2: 19-25, Apr 2018. Available from: URL: http:/ /www.who.int/medicines/publications/PharmaNewsletter2_18/en/ - Sweden 803322966 0114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved Reactions 2 Jun 2018 No. 1704
Reactions Weekly – Springer Journals
Published: Jun 2, 2018
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