Vexdopa Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C. No teratogenic effects were observed in a study in mice receiving up to 20 times the maximum recommended human dose of Carbidopa-Levodopa. There was a decrease in the number of live pups delivered by rats receiving approximately two times the maximum recommended human dose of carbidopa and approximately five times the maximum recommended human dose of levodopa during organogenesis. Carbidopa-Levodopa caused both visceral and skeletal malformations in rabbits at all doses and ratios of carbidopa/levodopa tested, which ranged from 10 times/5 times the maximum recommended human dose of carbidopa/levodopa to 20 times/10 times the maximum recommended human dose of carbidopa/levodopa. There are no adequate or well-controlled studies in pregnant women. It has been reported from individual cases that levodopa crosses the human placental barrier, enters the fetus, and is metabolized. Carbidopa concentrations in fetal tissue appeared to be minimal. Use of Carbidopa-Levodopa in women of childbearing potential requires that the anticipated benefits of the drug be weighed against possible hazards to mother and child.
Nursing Mothers: In a study of one nursing mother with Parkinson's disease, excretion of levodopa in human breast milk was reported. Therefore, caution should be exercised when Carbidopa-Levodopa is administered to a nursing woman.