Sedation with "non-sedating" antihistamines: four prescription-event monitoring studies in general practice.
OBJECTIVE
To investigate the frequency with which sedation was reported in post-marketing surveillance studies of four second generation antihistamines: loratadine, cetirizine, fexofenadine, and acrivastine.


METHODS
Prescription-event monitoring studies.


METHODS
Prescriptions were obtained for each cohort in the immediate post-marketing period.


METHODS
Event data were obtained for a total of 43 363 patients.


METHODS
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.
Mann
R D
RD
Southampton University, Southampton. DrMann@manorcottage.fsbusiness.co.uk
Pearce
G L
GL
Dunn
N
N
Shakir
S
S
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D017332:Cetirizine / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003244:Consciousness Disorders / Q000139:chemically induced*; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D017336:Loratadine / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012894:Sleep Stages / Q000187:drug effects; D016593:Terfenadine / Q000009:adverse effects / Q000031:analogs & derivatives; D014311:Triprolidine / Q000009:adverse effects / Q000031:analogs & derivatives
D006634:Histamine H1 Antagonists; D014311:Triprolidine; D017336:Loratadine; D016593:Terfenadine; C043648:acrivastine; C093230:fexofenadine; D017332:Cetirizine