Safe use of Baclofen during pregnancy or lactation has not been established. Baclofen crosses the placental barrier and passes into breast milk. High doses are associated with an increased incidence of abdominal hernias in the fetuses of rats and of ossification defects in those of rats and rabbits. Therefore, the drug should be administered to pregnant patients, or women of child-bearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible hazards.
Infants exposed to baclofen through maternal oral dosing during pregnancy are at risk of experiencing baclofen withdrawal at birth; identification of this condition may be confounded due to delayed appearance of withdrawal symptoms in this population.