title: Premarketing surveillance of ibuprofen suppositories in febrile children.
abstract: In many countries, ibuprofen is available only in oral formulations. The authors aimed to investigate parental satisfaction and possible adverse reactions among children receiving newly marketed ibuprofen suppositories, prior to their arrival at the pharmaceutical points of distribution. Children needing antipyretic medication were recruited from 11 pediatric wards and clinics in Israel. Each patient received ibuprofen suppositories (5-10 mg/kg/dose) after completing a data collection form. After 3 to 7 days of treatment, information regarding parent satisfaction, possible adverse reactions, and concomitant use of drugs was obtained. Overall, 490 children completed the study. Parents' satisfaction was high (4.5 ± 0.47 on a scale of 1-5), and 92.2% reported that they would use the medication in the future. Adverse reactions were reported in 8 patients (1.63%, 95% confidence interval = 1.77-3.25), the most common being diarrhea. Rectal administration of ibuprofen suppositories is well tolerated and overall satisfaction and the repeated expected use were high.
authors.affiliation: Division of Pediatrics and Clinical Pharmacology Unit, Assaf Harofeh Medical Center, Zerifin, Israel.
authors.forename: Dan
authors.initials: D
authors.lastname: Hadas
authors.forename: Ilan
authors.initials: I
authors.lastname: Youngster
authors.forename: Avner
authors.initials: A
authors.lastname: Cohen
authors.forename: Eugene
authors.initials: E
authors.lastname: Leibovitch
authors.forename: Itai
authors.initials: I
authors.lastname: Shavit
authors.forename: Ilan
authors.initials: I
authors.lastname: Erez
authors.forename: Yosef
authors.initials: Y
authors.lastname: Uziel
authors.forename: Matitiahu
authors.initials: M
authors.lastname: Berkovitch
mesh_terms: D000285:Administration, Rectal; D000328:Adult; D058633:Antipyretics / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005334:Fever / Q000188:drug therapy*; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects*; D007223:Infant; D008297:Male; D040541:Marketing; D010290:Parents; D017060:Patient Satisfaction; D013488:Suppositories
chemical_list: D058633:Antipyretics; D013488:Suppositories; D007052:Ibuprofen