Abstract
Baclofen, a gamma-aminobutyric acid analogue, is used as a muscle relaxant and antispasmodic to relieve symptoms in patients with intractable spasticity arising from cerebral or spinal aetiology such as in traumatic brain injury or multiple sclerosis. As it is often used in women of reproductive age, it is imperative to know the safety and associated maternal and fetal risks. The Food and Drug Administration has assigned the drug to Pregnancy Category C because of the lack of controlled data in humans. Animal studies have revealed an increased incidence of omphalocele if used in doses several times the recommended human dose. Baclofen should only be given during pregnancy when the benefits outweigh the risks. Baclofen is considered compatible with breast feeding by the American Academy of Pediatrics.