Healthy Skepticism Library item: 18016
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Mann RD, Pearce GL, Dunn N, Shakir S.
Sedation with 'non-sedating' antihistamines: four prescription-event monitoring studies in general practice - Commentary: Reporting of adverse events is worth the effort
BMJ 2000 Apr 29; 320:(7243):1184-6
http://www.bmj.com/cgi/content/full/320/7243/1184?view=long&pmid=10784544
Abstract:
OBJECTIVES: To investigate the frequency with which sedation was reported in post-marketing surveillance studies of four second generation antihistamines: loratadine, cetirizine, fexofenadine, and acrivastine. DESIGN: Prescription-event monitoring studies. SETTING: Prescriptions were obtained for each cohort in the immediate post-marketing period. SUBJECTS: Event data were obtained for a total of 43 363 patients. MAIN OUTCOME MEASURES: Reporting of sedation or drowsiness. RESULTS: The odds ratios (adjusted for age and sex) for the incidence of sedation were 0.63 (95% confidence interval 0.36 to 1.11; P=0.1) for fexofenadine; 2.79 (1.69 to 4.58; P<0.0001) for acrivastine, and 3.53 (2.07 to 5.42; P<0.0001) for cetirizine compared with loratadine. No increased risk of accident or injury was evident with any of the four drugs. CONCLUSIONS: Although the risk of sedation was low with all four drugs, fexofenadine and loratadine may be more appropriate for people working in safety critical jobs.
Keywords:
* Adolescent * Adult * Adverse Drug Reaction Reporting Systems * Aged * Cetirizine/adverse effects * Child * Child, Preschool * Consciousness Disorders/chemically induced* * Female * Histamine H1 Antagonists/adverse effects* * Humans * Infant * Infant, Newborn * Loratadine/adverse effects * Male * Middle Aged * Product Surveillance, Postmarketing * Sleep Stages/drug effects * Terfenadine/adverse effects * Terfenadine/analogs & derivatives * Triprolidine/adverse effects * Triprolidine/analogs & derivatives
