The safety of baclofen in pregnancy: intrathecal therapy in multiple sclerosis

Abstract

Intrathecal baclofen is a GABA-receptor agonist and one of the mainstay treatments of severe spasticity due to multiple sclerosis (MS). The authors report a case on the use of intrathecal baclofen administered using a Medtronic Synchromed II infusion pump. A healthy male infant (2.68 kg, Apgars 9 and 10) was born at 36 weeks gestation by cesarean section, under general anesthetic. This is the fifth reported case of intrathecal baclofen administered during pregnancy and adds to the knowledge that thus far it is relatively safe in pregnancy and may in fact be safer for the infant than oral baclofen. This is the first case report of the use of intrathecal baclofen in pregnancy and MS.

Spasticity: pathophysiology, evaluation and management

“…Stopping baclofen can provoke rebound spasticity within 48 h, though it usually settles after another 48 h. Sudden withdrawal may also cause seizures and hallucinations. Baclofen should be used with caution during pregnancy: although there are no reports of baclofen directly causing human fetal malformations, animal studies using high doses show that it causes impaired sternal ossification and omphalocele 24. Withdrawal from maternal baclofen occasionally provokes neonatal convulsions25 and so newborns of mothers taking baclofen should receive oral baclofen 0.5 mg per kg per day, weaned off over 9 days 26.…”

Outcome of patients with early T1 and T2 squamous cell carcinoma of the base of tongue managed by conventional surgery with adjuvant postoperative radiation

“…Oral baclofen during pregnancy has been associated with neonatal withdrawal seizures 27. Intrathecal baclofen pumps, which use 1–5% of the oral dosage, have been successfully used in pregnant women with multiple sclerosis and spasticity 28. Myobloc (botulinum toxin B) has not been linked to fetal harm but is pregnancy class C. Botox (botulinum toxin A) in extremely high dosages in mice and rats was associated with low birth weights and delayed ossification, and in rabbits with maternal toxicity, miscarriages, and fetal malformations 29.…”

Patient experiences with intrathecal baclofen as a treatment for spasticity – a pilot study

“…the effect of ITB on pregnancy). There are no controlled studies focusing on ITB and pregnancy [24], but a few case studies show the possibility to become pregnant and carry on pregnancy while receiving ITB treatment [24][25][26]. A thorough cooperation and coordination between maternity care and ITB care is important [25]; however, there is a need for more formalised routines in this matter.…”

“…A thorough cooperation and coordination between maternity care and ITB care is important [25]; however, there is a need for more formalised routines in this matter. In fertile women with neurological conditions, ITB is a quite common treatment, which makes it important to be aware of potential issues during pregnancy [24].…”