Exposure to antazoline-naphazoline eye drops during pregnancy and the risk of congenital malformations: a Danish nationwide cohort study
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
Exposure to antazoline-naphazoline eye drops during pregnancy and the risk of congenital malformations : a Danish nationwide cohort study. / Thomseth, Vilde; Cejvanovic, Vanja; Jimenez-Solem, Espen; Poulsen, Henrik E.; Utheim, Tor Paaske; Andersen, Jon T.
I: Acta Ophthalmologica, Bind 97, Nr. 5, 2019, s. 505-509.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
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.
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 -
ID: 224550799