The safety of calcium channel blockers during pregnancy: a prospective, multicenter, observational study.
OBJECTIVE
To assess the safety of calcium channel blockers during the first trimester of pregnancy.


METHODS
A multicenter (n=11), prospective observational study of the European Network of Teratology Information Services (ENTIS). The rate of major birth defects was compared between a cohort of pregnant women exposed to calcium channel blockers during the first trimester (n=299) and a control group not exposed to potential teratogens (n=806).


RESULTS
Major birth defects were not more common in the study group than in the control group. Birth weight was significantly lower in exposed term newborns. There were more preterm infants in the study group than in the control group (23.8% vs. 6.5%). These adverse effects are more likely due to the underlying disease than to the medication.


CONCLUSIONS
This study suggests that calcium channel blockers during the first trimester of pregnancy do not represent a major teratogenic risk.
Weber-Schoendorfer
Corinna
C
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, (BBGes), Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, 14050 Berlin, Germany. weber@embryotox.de
Hannemann
Doreen
D
Meister
Reinhard
R
Eléfant
Elisabeth
E
Cuppers-Maarschalkerweerd
Benedikte
B
Arnon
Judy
J
Vial
Thierry
T
Rodriguez-Pinilla
Elvira
E
Clementi
Maurizio
M
Robert-Gnansia
Elisabeth
E
De Santis
Marco
M
Malm
Heli
H
Dolivo
Alla
A
Schaefer
Christof
C
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000022:Abortion, Spontaneous / Q000453:epidemiology / Q000209:etiology*; D000293:Adolescent; D000328:Adult; D001724:Birth Weight; D002121:Calcium Channel Blockers / Q000009:adverse effects*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007557:Israel / Q000453:epidemiology; D008875:Middle Aged; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D047928:Premature Birth / Q000453:epidemiology / Q000209:etiology*; D011446:Prospective Studies
D002121:Calcium Channel Blockers