Risk of congenital anomalies in pregnant users of statin drugs

Benjamin Ofori, Evelyne Rey, Anick Bérard, Benjamin Ofori, Evelyne Rey, Anick Bérard

Abstract

Aims: Evidence from animal studies suggests that statin medications should not be taken during pregnancy. Our aim was to examine the association between the use of statins in early pregnancy and the incidence of congenital anomalies.

Methods: A population-based pregnancy registry was built. Three study groups were assembled: women prescribed statins in the first trimester (group A), fibrate/nicotinic acid in the first trimester (group B) and statins between 1 year and 1 month before conception, but not during pregnancy (group C). Among live-born infants, we selected as cases infants with any congenital anomaly diagnosed in the first year of life. Controls were defined as infants with no congenital anomalies. The rate of congenital anomalies in the respective groups was calculated. Adjusted odds ratios (OR) and 95% confidence intervals (CI) were also calculated.

Results: Our study group consisted of 288 pregnant women. Among women with a live birth, the rate of congenital anomalies was 3/64 (4.69%; 95% CI 1.00, 13.69) in group A, 3/14 in group B (21.43%; 95% CI 4.41, 62.57) and 7/67 in group C (10.45%; 95% CI 4.19, 21.53). The adjusted OR for congenital anomalies in group A compared with group C was 0.36 (95% CI 0.06, 2.18).

Conclusion: We did not detect a pattern in fetal congenital anomalies or evidence of an increased risk in the live-born infants of women filling prescriptions for statins in the first trimester of pregnancy. Conclusions, however, remain uncertain in the absence of data from non-live births.

Figures

Figure 1
Figure 1
Linkage between administrative databases used in study. NAM, Numéro d'assurance maladie (unique personal identification number); ICD-9, International Classification of diseases, 9th revision; ED, emergency department; DoB, date of birth
Figure 2
Figure 2
Pregnancy outcomes according to study group. *Women aged 15–45 years on first day of gestation; covered by Régie de l'Assurance Maladie du Québec drug insurance for ≥12 months before pregnancy and during pregnancy. †Women excluded; users of other known teratogens (category X drug; carbamazepine, phenytoin, valproic acid, lithium, acitretin, isotretinoin, antineoplastic agents, leflunomide and androgens). ‡Induced abortions identified by ICD-9 codes 635.0–635.9, 636.0–636.9, 779.6

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