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Neurological Disorders in Children Desloratadine, Loratadine Translated from Rev Prescrire January 2016; 3- Prescrire Rédaction “Loratadine: en cas de Translated from Rev Prescrire March 2016; 36 36 (387): 16 symptômes trop gênants” Rev Prescrire 2008; 28 (389): 189 (296): 428. 4- Prescrire Editorial Staff “Seasonal allergic rhini- tis: limited effectiveness of treatments” Prescrire Int Mizolastine: prefer 2008; 17 (93): 28-32. Desloratadine, loratadine: 5- Prescrire Rédaction “mizolastine-Mizollen°, cetirizine or loratadine Mistaline°. Un antihistaminique H1 de plus” Rev aggression Prescrire 1999; 19 (201): 811-814. • More adverse effects with mizo­ 6- Prescrire Rédaction “Patientes enceintes gênées • Neuropsychiatric reactions. lastine. par une rhinite allergique” Rev Prescrire 2015; 35 (386): 912-918. In February 2015, the Neth- 7- Prescrire Editorial Staff “Cetirizine and lorata- In France, mizolastine, a dine: minimal risk of QT prolongation” Prescrire Int erlands Pharmacovigilance so-called non-sedative, 2010; 19 (105): 26-28. Centre, Lareb, reported non-antimuscarinic antihis- 8- “Arrhytmias”. In: “Martindale The complete 22 cases of mental disor- drug reference” The Pharmaceutical Press, Lon- tamine, is authorised for don, www.medicinescomplete.com accessed ders attributed to desloratadine, a oral administration to adults and children 25 November 2015: 2 pages. “non-sedating” antihistamine without anti- over 12 years of age, as symptomatic muscarinic activity. These disorders treatment for seasonal or perennial aller- Translated from Rev Prescrire February 2016; included abnormal behaviour such as gic rhinoconjunctivitis, and for urticar- 36 (388): 108 agitation, aggression, violent thoughts, ia (1,2). A copy is also available, with the anxiety and depressed mood (1). Six same indications as the originator (1). reports involved children under 12 years Oral antihistamines are only moderate- Dextromethorphan: of age. The disorders resolved after ly effective in patients with severe symp- neurological disorders desloratadine cessation in 16 patients toms of allergic rhinitis, allergic conjunc- in children and recurred on rechallenge in 4 cases. tivitis or urticaria. Non-sedative, In 21 cases, desloratadine was the only non-antimuscarinic antihistamines such Do not use in young children. suspected drug. as cetirizine and loratadine are the best • In March 2015, the World Health Organ- choices. Mizolastine is no more effective In 2015, the Uppsala World ization (WHO) Uppsala pharmacovigi- than either of these drugs (2-5). Health Organization (WHO) lance database contained 17 reports of The adverse effect profile of mizolas- pharmacovigilance centre aggressive reaction attributed to deslo- tine consists mainly of sedative effects in published a review on ratadine. Ten involved children, including some patients (especially the elderly), adverse drug reactions in children attrib- 8 aged 8 years or under. The disorders fatigue, headache, gastrointestinal disor- uted to dextromethorphan, an opioid recurred in 2 children who were re- ders, dry mouth, and increased appetite used as an antitussive (1). In February exposed at least once to desloratadine. leading to weight gain (1,2,5). Mizolastine 2015, the Uppsala pharmacovigilance Desloratadine is a metabolite of lorata- can also cause cardiac arrhythmias with database contained 110 reports of neu- dine and, according to Lareb, the WHO QT prolongation, as well as bradycardia rological disorders in children under the database also contains reports of aggres- and tachycardia (2,6). The risk of QT age of 6 years: 29 cases of ataxia, and sive reactions attributed to lorata- prolongation appears to be lower with 10 cases of coma in children aged dine (2,3). As of early 2016, the SPC of cetirizine and loratadine (7). Unlike these 2 years or less, as well as reports of the loratadine-containing product market- latter drugs, in vitro studies suggest that convulsions and dyskinesia. When the ed in France under the brand name Clar- high mizolastine concentrations close search was broadened to include all chil- ityne° states that “nervousness” occurred potassium channels, an effect compatible dren under the age of 18 years, 51 cases in 2.3% of exposed children, and more with a risk of cardiac arrhythmias (8). of ataxia and 19 cases of coma were frequently than in children who received Mizolastine is metabolised by cyto- identified. Most of these reports did not placebo (4). chrome P450 isoenzyme CYP3A4. To involve accidental intake or overdose. In practice, loratadine and deslorata- avoid potentiating its effects, including its In France, several dextrometh orphan- dine are antihistamines presented as cardiac adverse effects, mizolastine must containing products are approved for having selective effects on peripheral not be combined with inhibitors of this cough in children from the age of rather than central H1-receptors. It is best enzyme, which include various macro- 30 months or 6 years (2). This opioid to inform patients or their carers that lides and azole antifungals. Mizolastine should not be used lightly, and it is these drugs also have neuropsychiatric must also be avoided in patients with risk important to remind parents that it should effects. factors for torsades de pointes (2,5). not be given to young children (3). ©Prescrire In practice, mizolastine has a less ©Prescrire favourable harm-benefit balance than Selected references from Prescrire’s literature other non-sedative, non-antimuscarinic Selected references from Prescrire’s literature search. antihistamines. Cetirizine and loratadine search. 1- Lareb “Desloratadine and abnormal behaviour” Kwartaalbericht 18 February 2015: 24-28. are better options for patients requiring 1- Sandberg L and Watson S “Dextromethorphan and serious neurological disorders in children” 2- Sandberg L “Desloratadine and aggressive reac- oral therapy but should not be overused. WHO Pharmaceuticals Newsletter 2015; (5): 18-19. tion” WHO Pharmaceuticals Newsletter 2015; (6): 25-30. ©Prescrire 2- ANSM “Base de données publique des médica- ments”. ansm.sante.fr accessed 21 December 3- Prescrire Rédaction “Desloratadine: troubles 2015: 3 pages. neurologiques” Rev Prescrire 2007; 27 (281): 190. 3- Prescrire Rédaction “16-1-8. Patients sous anti- 4- ANSM “RCP-Clarityne comprimés” 7 January Selected references from Prescrire’s literature tussif” Rev Prescrire 2015; 35 (386 suppl. inter- 2015: 4 pages. search. actions médicamenteuses). 1- ANSM “RCP-Mizollen” 3 janvier 2014 + “RCP-Mizocler” 8 November 2013: 10 pages. 2- Prescrire Rédaction “24-1. Patients allergiques” Rev Prescrire 2015; 35 (386 suppl. interactions médicamenteuses). PRESCRIRE INTERNATIONAL SEPTEMBER 2016/VOLUME 25 N° 174 • PAGE 215 Downloaded from english.prescrire.org on 01/10/2021 Copyright(c)Prescrire. For personal use only..
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