Background: We studied the human teratogenic risk of sulfasalazine because
this drug interferes with folate metabolism.
Methods: Case control study within the Hungarian Case Control Surveillance
of Congenital Abnormalities, 1980-1996; based on 22 865 new-born infants or
foetuses with congenital abnormalities, and 38 151 babies without any dete
cted congenital abnormalities (control group).
Results: Seventeen pregnant women (0.07%) were treated with sulfasalazine i
n the case group, and 26 (0.07%) in the control group. The overall adjusted
adds ratio of congenital abnormalities after sulfasalazine treatment was o
dds ratio = 1.2 (95% confidence interval: 0.6-2.1). None of the analyses in
dicated any significant increased prevalence of selected congenital abnorma
lities among the exposed compared with the not exposed.
Conclusions: We found no significant increased prevalence of selected conge
nital abnormalities in the children of women treated with sulfasalazine dur
ing pregnancy. However, the amount of information is limited and additional
data are needed to rule out a teratogenic effect.