Risk level in pregnancy: This medicine is classified as Category C.
Data from epidemiological studies that have included pregnant women do not indicate an increased risk of birth defects with exposure to bupropion during pregnancy.
Reproduction studies in laboratory animals (rats and rabbits) at doses up to 15-45 times the usual human dose have shown no adverse effects on fertility or fetus. However, in two studies on rabbits showed an increase in malformations at doses similar to those used in human clinical practice.
Several observational studies of small samples of patients not identified injuries in babies exposed. Thus, in a study of Michigan Medicaid recipients which included 229.101 pregnancies during the period between 1985 and 1992, were identified three infants who had been exposed to the drug during the first trimester. None of them presented malformations.
A record of the manufacturer showed 14 cases of drug exposure from wich only is known partial data. Of ten cases known, two ended in abortion and the remaining eight were normal babies.
Monitoring a group of 88 pregnant women who took bupropion, showed seven spontaneous abortions, one voluntary abortion, one child with clubfoot and fifty-seven normal children between exposed during the first trimester. The remaining exposed during the second and third quarters, were normal.
Among the experts, is considered that there are an insufficient number of published observations on the effects of bupropion during pregnancy, from which it is not possible to draw conclusions about its possible effects.
Since the effects on experimental animals are not predictive of human behavior, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Meaning of category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.