Respiratory Paradoxical Adverse Drug Reactions Associated with Acetylcysteine and Carbocysteine Systemic Use in Paediatric Patients A National Survey 英文参考文献.docVIP

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Respiratory Paradoxical Adverse Drug Reactions Associated with Acetylcysteine and Carbocysteine Systemic Use in Paediatric Patients A National Survey 英文参考文献.doc

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Respiratory Paradoxical Adverse Drug Reactions Associated with Acetylcysteine and Carbocysteine Systemic Use in Paediatric Patients A National Survey 英文参考文献

RespiratoryParadoxicalAdverseDrugReactions AssociatedwithAcetylcysteineandCarbocysteine SystemicUseinPaediatricPatients:ANationalSurvey PaulineMallet1,2.,NadjetteMourdi3.,Jean-ChristopheDubus4,Franc?oise Bavoux2,Marie-Jose′ Boyer-Gervoise5,Marie-Jose`pheJean-Pastor5,MartinChalumeau1,3* 1Department of pediatrics, Necker-Enfants Malades hospital, Paris Descartes, Assistance Publique – de Paris, Paris, France, 2Regional Universite′ Ho?pitaux PharmacovigilanceCenterandDepartmentofClinicalPharmacology,CochinSaintVincentdePaulHospital,Universite′ParisDescartes,AssistancePublique–Ho?pitauxde Paris,Paris,France,3InsermU953,Saint-Vincent-de-Paulhospital,Paris,France,4Unite′ dePneumologieetMe′decineInfantile,CNRSURMITE6236,CHUTimone-Enfants, Marseille,France,5RegionalPharmacovigilanceCenter,SalvatorHospital,AssistancePublique–Ho?pitauxdeMarseille,Marseille,France Abstract Objective: To report pediatric cases of paradoxical respiratory adverse drug reactions (ADRs) after exposure to oral mucolyticdrugs(carbocysteine,acetylcysteine)thatledtothewithdrawaloflicensesforthesedrugsforinfantsinFrance andthenItaly. Design:ThestudyfollowedtherecommendationsoftheEuropeanguidelinesofpharmacovigilanceformedicinesusedin thepaediatricpopulation. Setting: Cases voluntarily reported by physicians from 1989 to 2008 were identified in the national French pharmacovigilancepublicdatabaseandindrugcompanydatabases. Patients: The definition of paradoxical respiratory ADRs was based on the literature. Exposure to mucolytic drugs was arbitrarilydefinedashavingreceivedmucolyticdrugsforatleast2days(.200mg)andatleastuntilthedaybeforethefirst signsofthesuspectedADR. Results:Thenon-exclusiveparadoxicalrespiratoryADRsreportedin59paediatricpatients(medianage5months,range3 weeksto34months,98%youngerthan2yearsold)wereincreasedbronchorrheaormucusvomiting(n=27),worseningof respiratorydistressduringrespiratorytractinfection(n=35),dyspnoea(n=18),coughaggra