Table 2.
Prescribing for Willis-Ekbom Disease in Perinatal Women
| Agent | Pregnancy | Lactation |
|---|---|---|
| Bromocriptine | Not believed to increase risk of anomalies. Used in prolactinomas. Weigh risk vs benefit | No reports of toxicity. May reduce lactation |
| Cabergoline | Not believed to increase risk of anomalies. Use in fertility treatment | Reduces prolactin levels |
| Carbamazepine (approved for indication) | Teratogenic; neural tube defects and possibly craniofacial anomalies. Benefit for persistent seizures may outweigh risk but not in RLS. Vitamin K supplement in late pregnancy, evidence limited | Compatible as levels too low |
| Clonazepam | Neonatal withdrawal; effect further potentiated by concomitant SSRI | Possible sedating effects if drug accumulation |
| Clonidine (approved but off-label) | No structural anomalies expected (animals). Possible behavioral changes in neonates (animals and humans) | Minimally excreted in breast milk. Observe for hypotension; may reduce milk production |
| Gabapentin (approved for indication) | Fetal growth impairment and developmental delays in animal studies. Human data conflicting and true risk unknown | Levels in breast milk 1%-4% of weight-adjusted maternal dose. No known adverse effects in exposed neonates |
| Levodopa (approved but off-label) | Adverse pregnancy and fetal outcomes in animals at high doses. Limited human data suggest no adverse effects | May affect lactation by reducing prolactin. No other pediatric concerns |
| Opioids (approved but off-label) | Neonatal withdrawal | May be sedating to newborn |
| Pramipexole (approved for indication) | Human safety data very limited to case reports and case series | Secretion in breast milk not known. May affect lactation by reducing prolactin |
| Pregabalin (approved but off-label use) | Adverse effects on animal development. Limited human data | No data on transfer in breast milk but passage is probable |
| Ropinirole (approved for indication) | No human data. Animal data do not show malformations | Secretion in breast milk not known. May affect lactation by reducing prolactin |
| Tramadol | First-trimester exposure in Swedish registry showed a small increase in risk for cardiovascular anomalies and clubfoot; not confirmed by other studies | Potential respiratory depression as roughly 3% equivalent of typical newborn IV dose transferred via breast milk |
| Valproic acid | Teratogenic; use not justified | Justified use: AAP and WHO |
SSRI = selective serotonin reuptake inhibitors. See Table 1 legend for expansion of other abbreviations.