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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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@article{558c7a2163f946bb8dd240e744999426,
title = "Exposure to antazoline-naphazoline eye drops during pregnancy and the risk of congenital malformations: a Danish nationwide cohort study",
abstract = "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.",
keywords = "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",
author = "Vilde Thomseth and Vanja Cejvanovic and Espen Jimenez-Solem and Poulsen, {Henrik E} and Utheim, {Tor Paaske} and Andersen, {Jon T}",
note = "{\textcopyright} 2018 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",
year = "2019",
doi = "10.1111/aos.13980",
language = "English",
volume = "97",
pages = "505--509",
journal = "Acta Ophthalmologica",
issn = "1755-375X",
publisher = "Wiley-Blackwell Munksgaard",
number = "5",

}

RIS

TY - JOUR

T1 - Exposure to antazoline-naphazoline eye drops during pregnancy and the risk of congenital malformations

T2 - a Danish nationwide cohort study

AU - Thomseth, Vilde

AU - Cejvanovic, Vanja

AU - Jimenez-Solem, Espen

AU - Poulsen, Henrik E

AU - Utheim, Tor Paaske

AU - Andersen, Jon T

N1 - © 2018 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

KW - antazoline-naphazoline

KW - eye drops

KW - pregnancy

KW - safety

KW - topical

KW - Naphazoline/administration & dosage

KW - Follow-Up Studies

KW - Humans

KW - Male

KW - Anti-Allergic Agents/administration & dosage

KW - Pregnancy Trimester, First

KW - Incidence

KW - Young Adult

KW - Antazoline/administration & dosage

KW - Abnormalities, Drug-Induced/epidemiology

KW - Nasal Decongestants/administration & dosage

KW - Ophthalmic Solutions

KW - Adult

KW - Female

KW - Registries

KW - Retrospective Studies

KW - Infant, Newborn

KW - Risk Factors

KW - Population Surveillance/methods

KW - Pregnancy

KW - Denmark/epidemiology

KW - Pregnancy Outcome

U2 - 10.1111/aos.13980

DO - 10.1111/aos.13980

M3 - Journal article

C2 - 30479070

VL - 97

SP - 505

EP - 509

JO - Acta Ophthalmologica

JF - Acta Ophthalmologica

SN - 1755-375X

IS - 5

ER -

ID: 55739493