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Cited by 152Pharmacovigilance and Adverse Drug ReactionsPharmaceutical Practices and Patient OutcomesDrug-Induced Adverse Reactions

Sedation with "non-sedating" antihistamines: four prescription-event monitoring studies in general practice Commentary: Reporting of adverse events is worth the effort

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Mann, R. D·2000·BMJ
DOI 10.1136/bmj.320.7243.1184PMC PMC27362
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Abstract

# Sedation with “non-sedating” antihistamines: four prescription-event monitoring studies in general practice {#article-title-2} 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 measure: 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. # Commentary: Reporting of adverse events is worth the effort {#article-title-11}

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  • Fexofenadine and loratadine are reported as the least sedating oral antihistamine treatment options.

    “Fexofenadine and loratadine are reported as the least sedating oral antihistamine treatment options.2032,2033”

    From International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (2018) · cites this paper as [2032]

    The Results report that loratadine and fexofenadine had a lower incidence of reported sedation than acrivastine and cetirizine. The study compared only these four antihistamines, so it does not establish that they are the least sedating among all oral antihistamine options. (LLM, conf=0.85)

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Authors
Mann, R. D.
Affiliations
University of Southampton (GB)
Corresponding author
Mann, R. D
Venue
BMJ
Publisher
BMJ
Published
2000-04-29
Volume
320
Issue
7243
Pages
1184-1187
ISSN
0959-8138 (ISSN-L)
DOI
10.1136/bmj.320.7243.1184
PMC
PMC27362
OpenAlex
W1588576723
Cited by
152
References
14
Citations by year
2026: 4 · 2025: 3 · 2024: 6 · 2023: 2 · 2022: 4 · 2021: 1 · 2020: 4 · 2019: 2 · 2018: 6 · 2017: 5 · 2016: 3 · 2015: 2 · 2014: 7 · 2013: 3 · 2012: 5
Type
journal article
Language
en
Open access
Locations
  • BMJ (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • HighWire Press Open Archive (submittedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
  • Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
Keywords
second-generation antihistamines, sedation, sleepiness, loratadine, cetirizine, fexofenadine, acrivastine, adverse event reporting, post-marketing surveillance, prescription-event monitoring, general practice
MeSH terms
Adolescent, Adult, Aged, Child, Child, Preschool, Consciousness Disorders, Female, Histamine H1 Antagonists, Humans, Infant, Infant, Newborn, Male, Middle Aged, Product Surveillance, Postmarketing, Sleep Stages, Triprolidine, Terfenadine, Adverse Drug Reaction Reporting Systems, Cetirizine, Loratadine

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