A population-based case-control study of the safety of oral anti-tuberculosis drug treatment during pregnancy.
OBJECTIVE
To study the human teratogenic potential of isoniazid and other anti-tuberculosis drug treatment during pregnancy.


METHODS
Cases from a large population-based dataset at the Hungarian Case-Control Surveillance of Congenital Abnormalities, and controls from the National Birth Registry, between 1980 and 1996. Information on all oral anti-tuberculosis drug treatments during pregnancy was medically recorded.


METHODS
Women who had newborns or fetuses with congenital abnormalities (case group), and women who had babies with no congenital abnormality (control group).


METHODS
Congenital abnormalities in newborn infants and fetuses diagnosed prenatally during the second and third trimesters, and postnatally from birth to the age of one year.


RESULTS
Of 38,151 controls, 29 (0.08%) were exposed to anti-tuberculosis drug treatment during pregnancy; the corresponding figures for cases were 22,865 and 11 (0.05%). The prevalence odds ratio was 0.6 (95%CI 0.3-1.3). Analysis of isoniazid and other oral antituberculosis drug use during the second and third months of gestation, i.e., in the critical period for most major congenital abnormalities, in case-control pairs did not indicate a teratogenic effect of these drugs in any group with congenital abnormality.


CONCLUSIONS
Maternal exposure to oral anti-tuberculosis drugs during pregnancy did not show a detectable teratogenic risk to the fetus; however, the number of pregnant women who were treated with these drugs during the critical period of most major congenital abnormalities was limited (six cases vs. 21 controls).
Czeizel
A E
AE
Foundation for the Community Control of Hereditary Diseases, Department of Human Genetics and Teratology, National Center for Epidemiology, Budapest, Hungary. czeizel@interware.hu
Rockenbauer
M
M
Olsen
J
J
Sørensen
H T
HT
D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000284:Administration, Oral; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D016022:Case-Control Studies; D005260:Female; D005315:Fetal Diseases / Q000209:etiology*; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000209:etiology*; D007538:Isoniazid / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D018811:Maternal Exposure / Q000009:adverse effects; D016017:Odds Ratio; D011247:Pregnancy; D011256:Pregnancy Outcome; D011262:Pregnancy Trimester, Second; D011263:Pregnancy Trimester, Third
D000995:Antitubercular Agents; D007538:Isoniazid