Reboxetine use while Breastfeeding
Reboxetine Levels and Effects while Breastfeeding
Summary of Use during Lactation
Reboxetine is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Limited information indicates that maternal doses of up to 10 mg daily produce low levels in milk and appear to not result in any adverse effects in breastfed infants. Until more data are available, reboxetine should be used with careful monitoring during breastfeeding.
Maternal Levels. Four women with postpartum depression had been taking reboxetine in an average dose of 6.5 mg daily (range 4 to 10 mg daily) equivalent to 79 mcg/kg daily (range 44 to 172 mcg/kg daily) for an average of 2.5 months (range 1.3 to 4.1 months). The mothers collected fore- and hindmilk samples before the first daily dose and with each infant feeding throughout 24 hours (7 to 8 times). Average peak milk reboxetine levels of 16 mcg/L (range 10 to 21 mcg/L) occurred at an average of 4.3 hours (range 1 to 8.8 hours) after the dose. The mean of the average plasma concentrations was 11.3 mcg/L (range 6.7 to 16.3 mcg/L). The infant dosage averaged 1.7 mcg/kg daily (range 1 to 2.4 mcg/kg daily) which was 2% (range 1.4 to 2.5%) of the maternal weight-adjusted dosage.
Infant Levels. Four infants whose mothers had postpartum depression had been breastfed (extent not stated) for 1.3 to 2.1 months during maternal reboxetine therapy at an average dose of 6.5 mg (79 mcg/kg) daily. The infant dosage was calculated to be 1.7 mcg/kg daily (range 1 to 2.4 mcg/kg daily). Individual infant plasma levels obtained (times not stated) were 2.3, 2.6, 5 and undetectable (<4) mcg/L. The mean of the average maternal plasma concentrations was 192 mcg/L.
Effects in Breastfed Infants
Four infants whose mothers had postpartum depression had been breastfed (extent not stated) for 1.3 to 2.1 months during maternal reboxetine therapy at an average dose of 6.5 mg (79 mcg/kg) daily. One of the mothers was also taking escitalopram 20 mg daily and another was taking sertraline 300 mg daily. None of the infants exhibited any adverse reactions. Three of the infants had normal Denver developmental scores; the fourth whose mother was taking reboxetine had a developmental age of only 71% of normal, but the problem predated maternal reboxetine therapy.
Effects on Lactation and Breastmilk
Reboxetine increased serum prolactin in male subjects. The relevance of this finding to nursing mothers is not clear. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
An observational study looked at outcomes of 2859 women who took an antidepressant during the 2 years prior to pregnancy. Compared to women who did not take an antidepressant during pregnancy, mothers who took an antidepressant during all 3 trimesters of pregnancy were 30% less likely to be breastfeeding upon hospital discharge. Mothers who took an antidepressant only during the third trimester were 75% less likely to be breastfeeding at discharge. Those who took an antidepressant only during the first and second trimesters did not have a reduced likelihood of breastfeeding at discharge. The antidepressants used by the mothers were not specified.
Alternate Drugs to Consider
1. Hackett LP, Ilett KF, Rampono J et al. Transfer of reboxetine into breastmilk, its plasma concentrations and lack of adverse effects in the breastfed infant. Eur J Clin Pharmacol. 2006;62:633-8. PMID: 16699799
2. Coker F, Taylor D. Antidepressant-induced hyperprolactinaemia: incidence, mechanisms and management. CNS Drugs. 2010;24:563-74. PMID: 20527996
3. Venkatesh KK, Castro VM, Perlis RH et al. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression. Am J Obstet Gynecol. 2017;216:S466-S467.
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Adrenergic Uptake Inhibitors
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