Pholedrine was a frequently used
drug for the treatment of severe
hypotension in some countries, including Hungary. The possible teratogenic effect of
pholedrine was not checked; therefore; the birth outcomes, particularly
congenital abnormalities (CAs), of infants born to women treated with
pholedrine during pregnancy, and
pregnancy complications were evaluated in the population-based large dataset of the Hungarian Case-Control Surveillance System of
Congenital Abnormalities. Cases with CA and their matched controls without CA born to mothers with
pholedrine use during pregnancy were compared. Of 22 843 cases and 38 151 controls, 768 (3.4%) and 1509 (4.0%) were born to mothers with
pholedrine treatment, respectively (adjusted odds ratios [OR] with 95% CI: 0.9, 0.8-1.0). There was no higher risk for any CA group in the offspring of mothers who used
pholedrine during the second and/or third month of pregnancy (i.e. the critical period of most major CA). The mean gestational week at delivery and
birthweight was similar in newborns of women with or without
pholedrine treatment during pregnancy. The pattern of
pregnancy complications was characteristic (lower incidence of
preeclampsia/
eclampsia, while higher incidence of severe
nausea/
vomiting and
anemia), explained mainly by the underlying maternal
hypotension. In conclusion,
pholedrine treatment in pregnant women was not associated with a higher risk for CA or other
adverse birth outcomes, such as
preterm birth or low
birthweight. The knowledge of the teratogenic potential of
pholedrine may contribute to the evaluation of other
sympathomimetic drugs.