Risk of major congenital anomalies and beta‐blockers: A comparative study from the EFEMERIS database

Aims To evaluate if exposure to beta‐blockers during the first trimester of pregnancy increases the risk of congenital anomaly. Methods An observational comparative study was carried out. This study was conducted using EFEMERIS, a medico‐administrative database. We included women who had a pregnancy between 2004 and 2021 registered in EFEMERIS. Comparison of women receiving beta‐blockers during the first trimester of pregnancy with those receiving calcium channel blockers and with women unexposed to antihypertensive medications. Logistic regression models adjusted for relevant confounders were used to estimate the adjusted odds ratios (ORa) for major congenital anomalies. We calculated the ajusted Odds Ratio (ORa) and its 95% confidence intervals (CI) for major congenital anomalies. Results Data from 1813 pregnant women (1%) exposed to beta‐blockers, 2903 (1.6%) exposed to calcium channel blockers and 172 284 unexposed to any antihypertensive medication were compared. Multivariate analyses showed a statistically significant increased risk of major congenital anomalies in fetuses/children exposed to beta‐blockers (ORa[95% CI] = 1.56 [1.07–2.18]) compared with unexposed group. However, this increased risk was not observed when comparing with women exposed to calcium channel blockers (ORa[95% CI] = 0.71 [0.29–2.15]). An increased risk of major congenital anomalies was also observed in fetuses/children exposed to labetalol compared with those unexposed to antihypertensive medications (ORa [95% CI] = 2.00 [1.06–3.40]), but not when compared with those exposed to calcium channel blockers (ORa [95% CI] = 1.06 [0.37–3.48]). Conclusions This study found no increased risk of major congenital anomalies in women exposed to beta‐blockers compared with those exposed to calcium channel blockers in early pregnancy.