Also known as BRL 29060, Paroxetina, Paroxetinum

Can I take Paroxetine while breastfeeding?

Because of the low levels of paroxetine in breastmilk, amounts ingested by the infant are small and paroxetine has not been detected in the serum of most infants tested. Occasional mild side effects have been reported, especially in the infants of mothers who took paroxetine during the third trimester of pregnancy, but the contribution of the drug in breastmilk is not clear. Most authoritative reviewers consider paroxetine one of the preferred antidepressants during breastfeeding.[1][2][3][4][5] Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding and may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.

Drug levels

Maternal Levels. In a pooled analysis of serum levels from published studies and 3 unpublished cases, the authors found 50 mothers taking an average daily dosage of 21 mg (range 10 to 50 mg) had an average milk paroxetine level of 28 mcg/L (range 0 to 153 mcg/L).[1] Using the average dosage and milk level data from this paper, an exclusively breastfed infant would receive an estimated 1.2% of the maternal weight-adjusted dosage of paroxetine.

From data in 6 mothers taking paroxetine in an average daily dosage of 20 mg (range 10 to 30 mg), the authors estimated that an exclusively breastfed infant would receive 1.4% of the maternal weight-adjusted dosage.[6]

At 2 months postpartum, 19 mothers taking an average of 25 mg of paroxetine daily had average milk levels of 13.5 mcg/L at random times after the previous dose. The authors estimated that an exclusively breastfed infant would receive 0.02 mg/kg of paroxetine daily.[7]

A woman had taken paroxetine 15 mg daily during pregnancy. She did not receive a dose in the 22.75 hours before delivery or on the day of delivery. She resumed paroxetine 15 mg daily 24 hours postpartum. At 3.75 hours after the third postpartum dose, her breastmilk paroxetine level was 371 mcg/L.[8]

Four nursing mothers who were 6.5 to 18.5 weeks postpartum were taking paroxetine in doses of 12.5 to 60 mg daily in addition to quetiapine for major depression postpartum. Breastmilk samples obtained at various times after the dose had undetectable (<9.9 mcg/L) levels of paroxetine in 3 mothers. One mother who was taking 50 mg daily had a milk paroxetine level of 255 mcg/L.[9] Infant Levels. Sixteen breastfed infants (2 about 50% breastfed; the others 95% or more breastfed) aged 6 to 13 weeks had undetectable (<1 mcg/L) paroxetine serum levels during maternal therapy with paroxetine in an average daily dosage of 18.75 mg (range 5 to 30 mg).[10] In a pooled analysis of 40 mother-infant pairs from published and unpublished cases, the authors found that no infants had measurable paroxetine plasma levels.[1] In 6 breastfed (extent not stated) infants aged 2 to 33 weeks whose mothers were taking paroxetine in an average daily dosage of 20 mg (range 10 to 30 mg), paroxetine was undetectable (<1.6 mcg/L) in all of the infants' serum. One mother taking 20 mg daily and her infant were both poor metabolizers (homozygous for CYP2D6*4), yet no paroxetine was detectable in infant serum.[6] At 2 months postpartum, the breastfed infants of 19 mothers taking an average of 25 mg of paroxetine daily had an average serum paroxetine level of 0.95 mcg/L which was 5% of the maternal serum level.[7]

Effects in breastfed infants

Maternal Levels. In a pooled analysis of serum levels from published studies and 3 unpublished cases, the authors found 50 mothers taking an average daily dosage of 21 mg (range 10 to 50 mg) had an average milk paroxetine level of 28 mcg/L (range 0 to 153 mcg/L).[1] Using the average dosage and milk level data from this paper, an exclusively breastfed infant would receive an estimated 1.2% of the maternal weight-adjusted dosage of paroxetine.

From data in 6 mothers taking paroxetine in an average daily dosage of 20 mg (range 10 to 30 mg), the authors estimated that an exclusively breastfed infant would receive 1.4% of the maternal weight-adjusted dosage.[6]

At 2 months postpartum, 19 mothers taking an average of 25 mg of paroxetine daily had average milk levels of 13.5 mcg/L at random times after the previous dose. The authors estimated that an exclusively breastfed infant would receive 0.02 mg/kg of paroxetine daily.[7]

A woman had taken paroxetine 15 mg daily during pregnancy. She did not receive a dose in the 22.75 hours before delivery or on the day of delivery. She resumed paroxetine 15 mg daily 24 hours postpartum. At 3.75 hours after the third postpartum dose, her breastmilk paroxetine level was 371 mcg/L.[8]

Four nursing mothers who were 6.5 to 18.5 weeks postpartum were taking paroxetine in doses of 12.5 to 60 mg daily in addition to quetiapine for major depression postpartum. Breastmilk samples obtained at various times after the dose had undetectable (<9.9 mcg/L) levels of paroxetine in 3 mothers. One mother who was taking 50 mg daily had a milk paroxetine level of 255 mcg/L.[9] Infant Levels. Sixteen breastfed infants (2 about 50% breastfed; the others 95% or more breastfed) aged 6 to 13 weeks had undetectable (<1 mcg/L) paroxetine serum levels during maternal therapy with paroxetine in an average daily dosage of 18.75 mg (range 5 to 30 mg).[10] In a pooled analysis of 40 mother-infant pairs from published and unpublished cases, the authors found that no infants had measurable paroxetine plasma levels.[1] In 6 breastfed (extent not stated) infants aged 2 to 33 weeks whose mothers were taking paroxetine in an average daily dosage of 20 mg (range 10 to 30 mg), paroxetine was undetectable (<1.6 mcg/L) in all of the infants' serum. One mother taking 20 mg daily and her infant were both poor metabolizers (homozygous for CYP2D6*4), yet no paroxetine was detectable in infant serum.[6] At 2 months postpartum, the breastfed infants of 19 mothers taking an average of 25 mg of paroxetine daily had an average serum paroxetine level of 0.95 mcg/L which was 5% of the maternal serum level.[7]

Possible effects on lactation

Paroxetine can cause galactorrhea, usually with increased prolactin levels, in nonpregnant, nonnursing patients.[22][23][24][25][26][27][28] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, paroxetine was found to have a 3.1-fold increased risk of causing hyperprolactinemia compared to other drugs.[29] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

In a small prospective study, 8 primiparous women who were taking a serotonin reuptake inhibitor (SRI; 3 taking fluoxetine and 1 each taking citalopram, duloxetine, escitalopram, paroxetine or sertraline) were compared to 423 mothers who were not taking an SRI. Mothers taking an SRI had an onset of milk secretory activation (lactogenesis II) that was delayed by an average of 16.7 hours compared to controls (85.8 hours postpartum in the SRI-treated mothers and 69.1 h in the untreated mothers), which doubled the risk of delayed feeding behavior in the untreated group. However, the delay in lactogenesis II may not be clinically important, since there was no statistically significant difference between the groups in the percentage of mothers experiencing feeding difficulties after day 4 postpartum.[30]

A case control study compared the rate of predominant breastfeeding at 2 weeks postpartum in mothers who took an SSRI antidepressant throughout pregnancy and at delivery (n = 167) or an SSRI during pregnancy only (n = 117) to a control group of mothers who took no antidepressants (n = 182). Among the two groups who had taken an SSRI, 33 took citalopram, 18 took escitalopram, 63 took fluoxetine, 2 took fluovoxamine, 78 took paroxetine, and 87 took sertraline. Among the women who took an SSRI, the breastfeeding rate at 2 weeks postpartum was 27% to 33% lower than mother who did not take antidepressants, with no statistical difference in breastfeeding rates between the SSRI-exposed groups.[31]

Alternate drugs to consider

Nortriptyline, Sertraline

References

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. The Academy of Breastfeeding Medicine Protocol Committee. ABM clinical protocol #18: use of antidepressants in nursing mothers. Breastfeed Med. 2008;3:44-52.

3. Lanza di Scalea T, Wisner KL. Antidepressant medication use during breastfeeding. Clin Obstet Gynecol. 2009;52:483-97. PMID: 19661763

4. Berle JO, Spigset O. Antidepressant use during breastfeeding. Curr Women’s Health Rev. 2011;7:28-34. PMID: 22299006

5. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: A systematic review. Hum Psychopharmacol. 2015;30:4-20. PMID: 25572308

6. Berle JO, Steen VM, Aamo TO et al. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome P450 genotypes. J Clin Psychiatry. 2004;65:1228-34. PMID: 15367050

7. Oberlander TF, Grunau RE, Fitzgerald C et al. Pain reactivity in 2-month-old infants after prenatal and postnatal serotonin reuptake inhibitor medication exposure. Pediatrics. 2005;115:411-25. PMID: 15687451

8. Knoppert DC, Nimkar R, Principi T, Yuen D. Paroxetine toxicity in a newborn after in utero exposure: clinical symptoms correlate with serum levels. Ther Drug Monit. 2006;28:5-7. PMID: 16418684

9. Misri S, Corral M, Wardrop AA, Kendrick K. Quetiapine augmentation in lactation: a series of case reports. J Clin Psychopharmacol. 2006;26:508-11. PMID: 16974194

10. Hendrick V, Fukuchi A, Altshuler L et al. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 2001;179:163-6. PMID: 11483479

11. Rohan A. Drug distribution in human milk. Aust Prescriber. 1997;20:84.

12. Costei AM, Kozer E, Ho T et al. Perinatal outcome following third trimester exposure to paroxetine. Arch Pediatr Adolesc Med. 2002;156:1129-32. PMID: 12413342

13. Casper RC, Fleisher BE, Lee-Ancajas JC et al. Follow-up of children of depressed mothers exposed or not exposed to antidepressant drugs during pregnancy. J Pediatr. 2003;142:402-8. PMID: 12712058

14. Merlob P, Stahl B, Sulkes J. Paroxetine during breast-feeding: infant weight gain and maternal adherence to counsel. Eur J Pediatr. 2004;163:135-9. PMID: 14745552

15. Hendrick V, Smith LM, Hwang S et al. Weight gain in breastfed infants of mothers taking antidepressant medications. J Clin Psychiatry. 2003;64:410-2. PMID: 12716242

16. Laine K, Kytola J, Bertilsson L. Severe adverse effects in a newborn with two defective CYP2D6 alleles after exposure to paroxetine during late pregnancy. Ther Drug Monit. 2004;26:685-7. PMID: 15570195

17. Abdul Aziz A, Agab WA, Kalis NN. Severe paroxetine induced hyponatremia in a breast fed infant. J Bahrain Med Soc. 2004;16:195-8.

18. Lee A, Woo J, Ito S. Frequency of infant adverse events that are associated with citalopram use during breast-feeding. Am J Obstet Gynecol. 2004;190:218-21. PMID: 14749663

19. Ritz S. Quetiapine monotherapy in post-partum onset bipolar disorder with a mixed affective state. Eur Neuropsychopharmacol. 2005;15 (Suppl 3):S407. Abstract.

20. Hale TW, Kendall-Tackett K, Cong Z et al. Discontinuation syndrome in newborns whose mothers took antidepressants while pregnant or breastfeeding. Breastfeed Med. 2010. PMID: 20807106

21. Kieviet N, Hoppenbrouwers C, Dolman KM et al. Risk factors for poor neonatal adaptation after exposure to antidepressants in utero. Acta Paediatr. 2015;104:384-91. PMID: 25559357

22. Davenport E, Velamoor R. A case of paroxetine-induced galactorrhea. Can J Psychiatry. 2002;47:890-1. PMID: 12500767

23. Morrison J, Remick RA, Leung M et al. Galactorrhea induced by paroxetine. Can J Psychiatry. 2001;46:88-9. PMID: 11221498

24. Bonin B, Vandel P, Sechter D et al. Paroxetine and galactorrhea. Pharmacopsychiatry. 1997;30:133-4. PMID: 9271780

25. Gonzalez E , Minguez L, Sanguino RM. Galactorrhea after paroxetine treatment. Pharmacopsychiatry. 2000;33:118. Letter. PMID: 10855465

26. Egberts ACG, Meyboom RHB, De Koning FHP et al. Non-puerperal lactation associated with antidepressant drug use. Br J Clin Pharmacol. 1997;44:277-81. PMID: 9296322

27. Chakraborty S, Sanyal D, Bhattacharyya R, Dutta S. A case of paroxetine-induced galactorrhoea with normal serum prolactin level. Indian J Pharmacol. 2010;42:322-3.

28. Sertcelik S, Bakim B, Karamustafalioglu O. [High dose paroxetine-induced galactorrhea with normal serum prolactin level: A case report]. Klin Psikofarmakol Bul. 2012;22:355-6.

29. Trenque T, Herlem E, Auriche P, Drame M. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011;34:1161-6. PMID: 22077504

30. Marshall AM, Nommsen-Rivers LA, Hernandez LL et al. Serotonin transport and metabolism in the mammary gland modulates secretory activation and involution. J Clin Endocrinol Metab. 2010;95:837-46. PMID: 19965920

31. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012;28:181-8. PMID: 22344850

Last Revision Date

20150331

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Source: LactMed – National Library of Medicine (NLM)

3D Model of the Paroxetine molecule

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