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Bispebjerg Hospital - a part of Copenhagen University Hospital
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Exposure to antazoline-naphazoline eye drops during pregnancy and the risk of congenital malformations: a Danish nationwide cohort study

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Purpose: To investigate whether exposure to antazoline-naphazoline eye drops in the first trimester of pregnancy was associated with an increased risk of malformations in humans. Methods: All women giving live birth between 1997 and 2011 in Denmark were included in this nationwide cohort study. All women redeeming at least one prescription of antazoline-naphazoline eye drops during the first 84 days of pregnancy were identified. Logistic regression was used to estimate the odds ratios of malformations among exposed offspring compared to non-exposed offspring. Results: We identified 977 706 births between 1997 and 2011. A total of 3061 women (0.32%) were exposed to antazoline-naphazoline eye drops in the first trimester of pregnancy. The rate of congenital malformations was 3.0% (n = 93) in exposed offspring and 3.5% (n = 33 594) in unexposed offspring. First-trimester exposure to antazoline-naphazoline was not associated with major congenital malformations overall (odds ratio: 0.88, 95% confidence interval: 0.71–1.09) or with any specific major malformation. The number of redeemed prescriptions was unchanged during all trimesters of pregnancy as compared to before and after pregnancy (p < 0.05). Conclusion: Exposure to antazoline-naphazoline eye drops in the first trimester of pregnancy appears not to be associated with increased teratogenic risk.

Original languageEnglish
JournalActa Ophthalmologica
Volume97
Issue number5
Pages (from-to)505-509
Number of pages5
ISSN1755-375X
DOIs
Publication statusPublished - 2019

    Research areas

  • antazoline-naphazoline, eye drops, pregnancy, safety, topical, Naphazoline/administration & dosage, Follow-Up Studies, Humans, Male, Anti-Allergic Agents/administration & dosage, Pregnancy Trimester, First, Incidence, Young Adult, Antazoline/administration & dosage, Abnormalities, Drug-Induced/epidemiology, Nasal Decongestants/administration & dosage, Ophthalmic Solutions, Adult, Female, Registries, Retrospective Studies, Infant, Newborn, Risk Factors, Population Surveillance/methods, Pregnancy, Denmark/epidemiology, Pregnancy Outcome

ID: 55739493