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.

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 - Abnormalities, Drug-Induced/epidemiology

KW - Adult

KW - Antazoline/administration & dosage

KW - Anti-Allergic Agents/administration & dosage

KW - Denmark/epidemiology

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Incidence

KW - Infant, Newborn

KW - Male

KW - Naphazoline/administration & dosage

KW - Nasal Decongestants/administration & dosage

KW - Ophthalmic Solutions

KW - Population Surveillance/methods

KW - Pregnancy

KW - Pregnancy Outcome

KW - Pregnancy Trimester, First

KW - Registries

KW - Retrospective Studies

KW - Risk Factors

KW - Young Adult

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 -