The Basics

What is Nefazodone?

Used to treat depression.

Brand names for Nefazodone

Serzone

How Nefazodone is classified

Antidepressive Agents, Antidepressive Agents (Second-Generation)

Nefazodone During Pregnancy

Nefazodone pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Nefazodone while pregnant

Reproduction studies have been performed in pregnant rabbits and rats at daily doses up to 200 and 300 mg/kg, respectively (approximately 6 and 5 times, respectively, the maximum human daily dose on a mg/m2 basis). No malformations were observed in the offspring as a result of nefazodone treatment. However, increased early pup mortality was seen in rats at a dose approximately five times the maximum human dose, and decreased pup weights were seen at this and lower doses, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known. The no-effect dose for rat pup mortality was 1.3 times the human dose on a mg/m2 basis. There are no adequate and well-controlled studies in pregnant women. Nefazodone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Nefazodone While Breastfeeding

What are recommendations for lactation if you're taking Nefazodone?

Limited information indicates that usual doses of nefazodone produce low but variable levels in milk that would not be expected to cause adverse effects in a breastfed infant, especially if the infant is older than 2 months. However, adverse effects in a breastfed preterm infant have been reported. If nefazodone is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, other drugs may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

Limited information indicates that usual doses of nefazodone produce low but variable levels in milk that would not be expected to cause adverse effects in a breastfed infant, especially if the infant is older than 2 months. However, adverse effects in a breastfed preterm infant have been reported. If nefazodone is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, other drugs may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Nefazodone on milk supply

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 37% 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.[5] The antidepressants used by the mothers were not specified.

A retrospective cohort study of hospital electronic medical records from 2001 to 2008 compared women who had been dispensed an antidepressant during late gestation (n = 575) to those who had a psychiatric illness but did not receive an antidepressant (n = 1552) and mothers who did not have a psychiatric diagnosis (n = 30,535). Women who received an antidepressant were 37% less likely to be breastfeeding at discharge than women without a psychiatric diagnosis, but no less likely to be breastfeeding than untreated mothers with a psychiatric diagnosis.[6] None of the mothers were taking nefazodone.

Possible alternatives to Nefazodone

Nortriptyline, Paroxetine, Sertraline.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Weissman AM, Levy BT, Hartz AJ et al. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 2004;161:1066-78. PMID: 15169695
2. Dodd S, Buist A, Burrows GD et al. Determination of nefazodone and its pharmacologically active metabolites in human blood and breast milk by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl. 1999;730:249-55. PMID: 10448960
3. Dodd S, Maguire KP, Burrows GD et al. Nefazodone in the breast milk of nursing mothers: a report of two patients. J Clin Psychopharmacol. 2000;20:717-8. Letter. PMID: 11106156
4. Yapp P, Ilett KF, Kristensen JH et al. Drowsiness and poor feeding in a breast-fed infant: association with nefazodone and its metabolites. Ann Pharmacother. 2000;34:1269-72. PMID: 11098340
5. Venkatesh KK, Castro VM, Perlis RH et al. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression: An observational cohort study. J Perinatol. 2017;37:1003-9. PMID: 28682318
6. Leggett C, Costi L, Morrison JL et al. Antidepressant use in late gestation and breastfeeding rates at discharge from hospital. J Hum Lact. 2017;33:701-9. PMID: 28984528

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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