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BMJ. 2000 Apr 29;320(7243):1184-6.

Sedation with "non-sedating" antihistamines: four prescription-event monitoring studies in general practice.

Author information

1
Southampton University, Southampton. DrMann@manorcottage.fsbusiness.co.uk

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.

PMID:
10784544
PMCID:
PMC27362
[Indexed for MEDLINE]
Free PMC Article
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