The safety of calcium channel blockers in human pregnancy: a prospective, multicenter cohort study.
OBJECTIVE
Our purpose was to examine the potential teratogenicity of calcium channel blockers.


METHODS
Six teratogen information services prospectively collected and followed up 78 women with first-trimester exposure to calcium channel blockers. Pregnancy outcome was compared (by paired t text of chi2 analysis) with that of a control group matched for maternal age and smoking.


RESULTS
There was no increase in major malformation (2/66=3.0% [calcium channel blockers] vs 0% [nonteratogenic controls], p=0.27); a fivefold increase was ruled out (baseline 2%, alpha = 0.05, beta = 0.20). The defects reported were attributable to maternal diabetes or coingestion of teratogens. The increase in preterm delivery 28% [calcium channel blockers] vs 9% [nonteratogenic controls], p=0.003), attributed to maternal disease by stepwise regression, was the most important factor responsible for the observed decrease in birth weight (mean -334 gm vs nonteratogenic controls, p=0.08).


CONCLUSIONS
This study suggests that calcium channel blockers do not represent a major teratogenic risk.
Magee
L A
LA
Motherisk Program, Division of Clinical Pharmacology/Toxicology, Hospital for Sick Children, Toronto, Ontario, Canada.
Schick
B
B
Donnenfeld
A E
AE
Sage
S R
SR
Conover
B
B
Cook
L
L
McElhatton
P R
PR
Schmidt
M A
MA
Koren
G
G
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000328:Adult; D001724:Birth Weight / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000009:adverse effects*; D016022:Case-Control Studies; D016009:Chi-Square Distribution; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D012044:Regression Analysis
D002121:Calcium Channel Blockers