Is Nefopam safe while breastfeeding?

Summary of use during breastfeeding

Nefopam is not approved in the United States by the Food and Drug Administration. The amount of nefopam in breastmilk with usual maternal dosages is small. Nefopam does not appear to adversely affect the milk supply or the neurobehavioral scores of breastfed neonates. Breastfeeding is acceptable during maternal use of nefopam, although some recommend not using it after 48 hours postpartum.[1]

Effects on the breastfed infant

Sixty-six women who had cesarean section deliveries were two groups postpartum: intravenous (IV) nefopam 20 mg every 6 hours or IV acetaminophen 1 gram every 6 hours as well as IV ketoprofen 50 mg every 6 hours in both groups Neonatal neurobehavioral scores were recorded at 12, 24, 48, and 72 hours post-caesarean by a pediatrician blinded to the group allocation. No difference was found between the groups in the behavioral scores.[3]

Effects on milk supply

Sixty-six women who had cesarean section deliveries were two groups: IV nefopam 20 mg every 6 hours or IV acetaminophen 1 gram every 6 hours. All women received the same preoperative analgesia consisting of spinal bupivacaine, sufentanil, and morphine as well as intravenous ephedrine and phenylephrine to prevent hypotension. Postoperatively, all received IV oxytocin by infusion and IV ketoprofen 50 mg every 6 hours. Milk production was assessed by weighing the newborn before and after each breastfeed on days 2 and 3. No statistical differences were seen between the two groups in the weight difference before and after each feed, the newborn daily weight curve evolution, or the fall in weight between days 0 and 2. Mothers also rated their breast fullness to assess the onset of lactogenesis II; no difference was found between the two groups in the time to lactogenesis II. There was also no difference in serum prolactin between the groups.[3]

Levels in milk

Maternal Levels. Human milk and plasma samples were obtained from 5 nursing mothers who were taking nefopam hydrochloride 60 mg every 4 hours for post-episiotomy pain. Samples of breastmilk were collected at 5 variable times over about 100 hours after the first dose. Milk concentrations varied from 6 to 299 mcg/L. The authors calculated that the highest dosage that a fully breastfed infant would receive would be about 50 mcg/kg daily or less than 3% of the weight-adjusted maternal dosage.[2]

Infant Levels. Relevant published information was not found as of the revision date.

Nefopam in pregnancy

LactMed covers breastfeeding only. For what the NHS and the US prescribing label say about pregnancy, see:

• Is nefopam safe in pregnancy and breastfeeding?