Congenital Anomalies

Prescribed opioid analgesics in early pregnancy and the risk of congenital anomalies: a population-based cohort study

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Abstract

Background: Recent data suggest an increased risk of congenital anomalies with prenatal exposure to opioid analgesics. We sought to further quantify the risk of anomalies after opioid analgesic exposure during the first trimester in a population-based cohort study.

Methods: Using administrative health data from Ontario, we followed 599 579 gestational parent–infant pairs from singleton pregnancies without opioid use disorder. We identified opioid analgesics dispensed in the first trimester and congenital anomalies diagnosed during the first year of life. We estimated propensity score–adjusted risk ratios (RRs) between first trimester exposure (any opioid analgesic and specific agents) and congenital anomalies (any anomaly, organ system anomalies, major or minor anomalies and specific anomalies).

Results: The prevalence of congenital anomalies was 2.8% in exposed infants and 2.0% in unexposed infants. Relative to unexposed infants, we observed elevated risks among those who were exposed for some anomaly groups, including gastrointestinal anomalies (any opioid analgesic: adjusted RR 1.46, 95% confidence interval [CI] 1.15–1.85; codeine: adjusted RR 1.53, 95% CI 1.12–2.09; tramadol: adjusted RR 2.69, 95% CI 1.34–5.38) and several specific anomalies, including ankyloglossia (any opioid: adjusted RR 1.88, 95% CI 1.30–2.72; codeine: adjusted RR 2.14, 95% CI 1.35–3.40). These findings persisted in sensitivity analyses.

Interpretation: Although the absolute risk of congenital anomalies was low, our findings add to accumulating data that suggest a small increased risk of some organ system anomalies and specific anomalies with first trimester exposure to opioid analgesics. These findings further quantify the potential risks associated with prenatal exposure to opioid analgesics to inform treatment choices for pain in pregnancy.

Fetal Exposure to Montelukast and Congenital Anomalies: A Population Based Study in Denmark

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Abstract

Background

The objective was to study pregnancy outcomes between groups of Danish women, with pregnancy ending between 1998 and 2009, according to their exposure to montelukast.

Methods

Cross‐sectional observational study in Danish women, selecting live births and stillbirths (Birth Registry) and spontaneous abortions and induced terminations (Patient Registry). Montelukast exposure was obtained from the Prescription Registry (ATC code R03DC03). Exposure period was from 3 months before the last menstrual period until the end of the first trimester. Four groups were studied: (1) women with prescription for montelukast, (2) women with prescription for montelukast and other anti‐asthmatic medications, (3) women with prescription for other anti‐asthmatic medications, (4) women without prescription for any anti‐asthmatic medications.

Results

A total of 754,300 singleton pregnancies (> 12 weeks) were identified: 401 pregnancies in group 1, 426 pregnancies in group 2, 24878 in group 3 and 728,595 in group 4. Risk of preterm birth, maternal preeclampsia and gestational diabetes was increased for pregnancies exposed to montelukast. No significant differences were found for the risk of major congenital anomalies (CA). Adjusted odds ratio for CA was 1.4 (95% CI 0.9–2.3) for the group 1 and 1.0 (95% CI 0.6–1.8) for group 2.

Conclusion

Pregnant women with prescriptions for montelukast had a higher risk of preterm birth and maternal complications. These risks are known to be associated with maternal asthma, no increased risk of CA was found. Further analysis including more exposed pregnancies will be needed to determine the risk of specific CA.