Use of contemporary antidepressants during breastfeeding: A proposal for a specific safety index

Drug Safety

Volumn 30, Issue 2, 2007, Pages 107-121

  Gentile, Salvatore ^a  

^a Mental Health Center N4   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; ANTIDEPRESSANT AGENT; BUSPIRONE; CARBAMAZEPINE; CITALOPRAM; DULOXETINE; ESCITALOPRAM; FLUOXETINE; FLUVOXAMINE; MIRTAZAPINE; NEFAZODONE; PAROXETINE; QUETIAPINE; REBOXETINE; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; VENLAFAXINE;

ABSENCE OF SIDE EFFECTS; AGITATION; BODY TEMPERATURE DISORDER; BREAST FEEDING EDUCATION; CLINICAL TRIAL; COLIC; CONTROLLED CLINICAL TRIAL; CRYING; DEPRESSION; DROWSINESS; DRUG BLOOD LEVEL; DRUG SAFETY; FEVER; HUMAN; HYPERACTIVITY; INSOMNIA; IRRITABILITY; JAUNDICE; LETHARGY; MUSCLE HYPOTONIA; NARCOLEPSY; PAIN; PRIORITY JOURNAL; PUERPERIUM; RESTLESSNESS; REVIEW; RISK FACTOR; SEIZURE; SEROTONIN BLOOD LEVEL; SIDE EFFECT; SLEEP; SOMNOLENCE; STARTLE REFLEX; VOMITING; WEIGHT GAIN; WITHDRAWAL SYNDROME;

ADRENERGIC UPTAKE INHIBITORS; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTIDEPRESSIVE AGENTS; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; BREAST FEEDING; DEPRESSION, POSTPARTUM; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; MILK, HUMAN; PRACTICE GUIDELINES; REGISTRIES; RISK ASSESSMENT; SEROTONIN UPTAKE INHIBITORS;

EID: 33846683190     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730020-00002     Document Type: Review

References (119)

1. Murray CJL, Lopez AD, editors. The global burden of disease: a comprehensive assessment of mortality and disability from disease, injures and risk factors in 1990 and 2020. Cambridge (MA): Harvard University Press, 1996
2. O' Hara MW, Neunaber DJ, Zekoski EM. Prospective study of postpartum depression: prevalence, course, and predictive factors. J Abnorm Psychol 1984; 93: 158-71
3. O' Hara MW, Swain AM. Rates and risk of postpartum depression: a meta-analysis. Int Rev Psychiatry 1996; 8: 37-54
4. Troutman B, Cutrona C. Nonpsychotic postpartum depression among adolescent mothers. J Abnorm Psychol 1990; 99: 69-78
5. Halbreich U, Karkun S. Cross-cultural and social diversity of prevalence of postpartum depression and depressive symptoms. J Affect Dis 2006. In press
6. Coates AO, Schafer CA, Alexander JL. Detection of postpartum and anxiety in a large health plan. J Behav Health Serv Res 2004; 31: 117-33
7. Whitton A, Warner R, Appleby L. The pathway to care in postnatal depression: women's attitudes to postnatal depression and its treatment. Br J Gen Pract 1996; 46: 427-8
8. Buist A, Biliszta J, Barnett B, et al. Recognition and management of perinatal depression in general practice. Austr Fam Phys 2005; 34 (9): 787-90
9. Radke-Arrow M, Nottelman E, Martinez P, et al. Young children of affectively ill parents. A longitudinal study of psychosocial adjustment. J Am Acad Child Adol Psychiatry 1992; 31: 68-77
10. Puckering C. When a parent suffers from an affective disorder: effect on the child. In: Göpfert M, Webster J, Seeman MV, editors. Parental psychiatric disorder: distressed parents and their families. Cambridge: Cambridge University Press, 2004: 172-84
11. Coghill S, Caplan C, Alexandra H, et al. Impact of postnatal depression on cognitive development in young children. BMJ 1986; 292: 1165-7
12. Field T, Healy B, Goldstein S, et al. Infants of depressed mothers show "depressed" behaviour even with non-depressed adults. Child Dev 1998; 59: 1569-79
13. Ryan D, Milis R, Misri N. Depression during pregnancy. Can Fam Physician 2005; 51: 1087-93
14. Mian AI. Depression in pregnancy and postpartum period: balancing adverse effects of untreated illness with treatment risk. J Psychiatric Pract 2004; 11 (6): 389-96
15. Hatton DC, Harrison-Hohner J, Coste S, et al. Symptoms of postpartum depression and breastfeeding. J Hum Lact 2005; 21 (44): 444-9
16. Gentile S. More than half of women with a history of psychosis have a psychiatric episode in the first year after childbirth [Invited commentary]. Evidence-Based Mental Health 2005; 32 (3): 33
17. Allen J, Hector D. Benefits of breastfeeding. N S W Public Health Bull 2005; 16 (3-4): 42-6
18. Bachrach VR, Scwarz E, Bachrach LR. Breastfeeding and the risk of hospitalization for respiratory disease in infancy: a meta-analysis. Arch Ped Adolesc 2003; 157: 237-43
19. Khadivzadeh T, Parsai S. Effect of exclusive breastfeeding and complementary feeding on infant growth and morbidity. East Mediterr Health 2004; 10 (3): 289-94
20. Garcia-Carega M Jr, JA Jr, Kerner JA. Gastrointestinal manifestations of food allergies in pediatric patients. Nutr Clin Pract 2005; 20 (85): 526-35
21. Friedman NJ, Zeiger RS. The role of breast-feeding in the development of allergies and asthma. J Allergy Clin Immunol 2005; 115 (6): 1238-48
22. Obihara CC, Marais BJ, Gie RP, et al. The association of prolonged breastfeeding and allergic disease in poor urban children. Eur Respir J 2005; 25 (6): 970-7
23. Kwan ML, Buffler PA, Abrams B, et al. Breastfeeding and the risk of childhood leukaemia: a meta-analysis. Public Health Rep 2004; 119: 521-35
24. Slykerman RF, Thomson JM, Becroft DM, et al. Breastfeeding and intelligence of preschool children. Acta Paediatr 2005; 94 (7): 832-7
25. McVea KL, Turner PD, Peppler DK. The role of breastfeeding in sudden death infant syndrome. J Hum Lact 2000; 16 (1): 13-20
26. Malcova H, Sumnik Z, Drevinek P, et al. Absence of breastfeeding is associated with the risk of type 1 diabetes: a case-control study in a population with rapidly increasing incidence. Eur J Pediatr 2006; 165 (2): 114-9
27. Groer MW, Davis MW, Smith K, et al. Immunity, inflammation and infection in post-partum breast and formula feeders. Am J Reprod Immunol 2005; 54 (4): 221-31
28. Newton N, Newton M. Physiologic aspects of lactation. N Engl J Med 1967; 277: 1179-88
29. Cunningham FG, MacDonald PC, Leveno KJ, et al. The puerperium. In: William's Obstetrics. Norwalk: Appleton & Lange, 1993: 459-73
30. Lawrence R, Lawrence R. Breastfeeding: a guide for the medical profession (5th ed.). Mosby, St. Louis, 1999
31. Byers T, Graham S, Rzepka T, et al. Lactation and breast cancer: evidence for a negative association in premenopausal women. Am J Epidemiol 1985; 121: 664-7
32. Whitby DH, Smith KM. The use of tricyclic antidepressants and selective serotonin reuptake inhibitors in women who are breastfeeding. Pharmacotherapy 2005; 25 (3): 411-25
33. Freeman MP, Anthony M. Focus on women's mental health [Editorial]. J Clin Psychiatry 2004; 65: 1164-5
34. Levin RJ. Ethics and regulation of clinical research. New Haven: Yale University Press, 1986: 240-1
35. Guidelines for preparing core clinical safety information on drugs. Geneva: Report from CIOMS Group III, 1994
36. Moretti ME, Sharma A, Bar-Oz B, et al. Fluoxetine and its effects on the nursing infant: a prospective cohort study [abstract PI-95]. Clin Pharmacol Ther 1989; 65 (2): 141
37. Isenberg KE. Excretion of fluoxetine in human breast milk [letter]. J Clin Psychiatry 1990; 51 (4): 169
38. Burch KJ, Wells G. Fluoxetine/norfluoxetine concentrations in human milk. Pediatrics 1992; 89: 676-7
39. Lester BM, Cucca J, Andreozzi L, et al. Possible association between fluoxetine hydrochloride and colic in an infant. J Am Acad Child Adolesc Psychiatry 1993; 32: 1253-5
40. Taddio A, Ito S, Koren G. Excretion of fluoxetine and its metabolite, norfluoxetine, in human breast milk. J Clin Pharmacol 1996; 36: 42-7
41. Kim J, Misri S, Riggs KW, et al. Stereoselective excretion of fluoxetine and norfluoxetine in breastmilk and neonatal exposure. Presented at the American Psychiatric Association Annual Meeting; 1997 May; San Diego
42. Chambers CD, Anderson PO, Thomas RG, et al. Weight gain in infants breastfed by mothers who take fluoxetine [online]. Available from URL: http://pediatrics.aappublications.org/ [Accessed 2006 Dec 5]
43. Heikkinen T, Ekblad U, Palo P, et al. Pharmacokinetics of fluoxetine and norfluoxetine in pregnancy and lactation. Clin Pharmacol Ther 2003; 73: 330-7
44. Hendrick V, Stowe ZN, Altshuler LL, et al. Fluoxetine and norfluoxetine concentrations in nursing infants and breastmilk. Biol Psychiatry 2001; 50: 775-82
45. Epperson CN, Jatlow PI, Czarkowski MA, et al. Maternal fluoxetine treatment in the postpartum period: effects on platelet serotonin and plasma drug levels in breast-feeding mother-infant pairs [online]. Available from URL: http://www.pediatrics.org/content/full/112/5/e425 [Accessed 2005 Oct 15]
46. Yoshida K, Smith B, Craggs M, et al. Fluoxetine in breast-milk and developmental outcomes if breast-fed infants. Br J Psychiatry 1998; 172: 175-9
47. Berle JØ, 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 (9): 1228-34
48. 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
49. Hale TW, Shum S, Grossberg M. Fluoxetine toxicity in a breastfed infant. Clin Pediatr 2001; 40: 681-4
50. Brent NB, Wisner LK. Fluoxetine and carbamazepine concentrations in a nursing mother/infant pair. Clin Pediatr 1998; 37: 41-4
51. Kristensen JH, Ilett KF, Hackett LP, et al. Distribution and excretion of fluoxetine and norfluoxetine in human milk. Br J Clin Pharmacol 1999; 48: 521-7
52. 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
53. Suri R, Stowe ZN, Hendrick V, et al. Estimating of nursing infant daily dose fluoxetine through breast milk. Biol Psychiatry 2002; 52: 446-51
54. Kim J, Riggs KW, Misri S, et al. Stereoselective disposition of fluoxetine and norfluoxetine during pregnancy and breastfeeding. Br J Clin Pharmacol 2006; 61 (2): 155-63
55. Spigset O, Carleborg L, Öhman R, et al. Excretion of citalopram in breast milk. Br J Psychopharmacol 1997; 44: 295-8
56. Jensen PR, Olesen OV, Bertelsen A, et al. Citalopram and desmethylcitalopram concentrations in breast milk and in serum of mother and infant. Ther Drug Monitor 1997: 236-9
57. Öhman I, Norstedt Wikner B, Vitols S. Citalopram and metabolite levels in plasma and breast milk in two nursing women [abstract no. 581]. Eur J Clin Pharmacol 1997; 52: A179
58. Heikkinen T, Ekblad U, Kero P, et al. Citalopram in pregnancy and lactation. Clin Pharmacol Ther 2002; 72 (2): 184-91
59. Rampono J, Kristensen JH, Hackett LP, et al. Citalopram and demethylcitalopram in human milk: distribution, excretion and effects in breast fed infants. Br J Clin Pharmacol 2000; 50: 263-8
60. Schmidt K, Olesen OV, Jensen PN. Citalopram and breastfeeding: serum concentration and side effects in the infant. Biol Psychiatry 2000; 47: 164-5
61. 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
62. Franssen EJF, Meijs V, Ettaher F, et al. Citalopram serum and milk levels in mother and infant during lactation. Ther Drug Monit 2006; 28: 2-4
63. Rampono J, Hackett LP, Kristensen LP, et al. Transfer of escitalopram its active metabolite desmethylescitalopram into breastmilk. Br J Clin Pharmacol 2006; 62: 316-22
64. Gentile S. Escitalopram late in pregnancy and while breast-feeding [letter]. Ann Pharmacother 2006; 40 (9): 1697
65. Spigset O, Carleborg L, Noström Å, et al. Paroxetine level in breast milk [letter]. J Clin Psychiatry 1996; 57 (1): 39
66. Öhman R, Hägg S, Carleborg L, et al. Excretion of paroxetine into breast milk. J Clin Psychiatry 1999; 60: 519-23
67. Hendrick V, Stowe ZN, Altshuler L, et al. Paroxetine use during breastfeeding [letter]. J Clin Psychopharmacol 2000; 20 (5): 587-9
68. Misri S, Kim J, Riggs KW, et al. Paroxetine levels in postpartum depressed women, breast milk, and infant serum. J Clin Psychiatry 2000; 61 (11): 828-32
69. Stowe ZN, Cohen LS, Hostetter A, et al. Paroxetine in human breast milk and nursing infants. Am J Psychiatry 2000; 157 (2): 185-9
70. Nordeng H, Bergsholm YK, Boiler E, et al. The transfer of serotonin reuptake inhibitors to human milk [in Norwegian]. Tidsskr Nor Laegeforen 2001; 121: 199-203
71. Hendrick V, Fukuchi A, Altshuler L, et al. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry 2001; 179: 163-6
72. 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
73. Begg EJ, Duffull SB, Saunders DA, et al. Paroxetine in human milk. Br J Clin Pharmacol 1999; 48 (2): 142-7
74. Wisner LK, Perel JM, Blumer J. Serum sertraline and N-desmethylsertraline levels in breast-feeding mother-infant pairs. Am J Psychiatry 1998; 155 (5): 690-2
75. Kent LSW, Laidlaw JDD. Suspected congenital sertraline dependence. Br J Psychiatry 1995; 167: 412-3
76. Epperson N, Czarkowsky KA, Ward-O'Brien D, et al. Maternal sertraline treatment and serotonin transport in breast-feeding mother-infant pairs. Am J psychiatry 2001; 158 (10): 1631-7
77. Altshuler LL, Burt VK, McMullen M, et al. Breastfeeding and sertraline: a 24-hours analysis. J Clin Psychiatry 1995; 56 (6): 243-5
78. Mammem OK, Perel JM, Rudolph G, et al. Sertraline and norsertraline levels in three breastfed infants. J Clin Psychiatry 1997; 58 (3): 100-3
79. Epperson CN, Anderson GM, McDougle CJ. Sertraline and breastfeeding [letter]. New Engl J Med 1997; 336: 1189-90
80. Stowe ZN, Owens MJ, Landry JC, et al. Sertraline and desmethylsertraline in human breast milk and nursing infants. Am J Psychiatry 1997; 154: 1255-60
81. Stowe ZN, Hostetter AM, Owens MJ, et al. The pharmacokinetics of sertraline excretion into human breast milk: determinants of infant serum concentrations. J Clin Psychiatry 2003; 64 (1): 73-80
82. Dodd S, Stocky A, Buist A, et al. Sertraline in paired blood plasma and breast-milk samples from nursing mothers. Hum Psychopharmacol Clin Exp 2000; 15: 261-4
83. Kristensen JH, Ilett KF, Dusci LJ, et al. Distribution and excretion of sertraline and N-desmethylsertraline in human milk. Br J Clin Pharmacol 1998; 45: 453-7
84. Dodd S. Sertraline analysis in the plasma of breastfed infants [letter]. Aust N Z J Psychiatry 2001; 33: 545-6
85. Winn SS, Drawer PO, Stowe ZN, et al. Sertraline in breast milk and nursing infants [abstract no. #NR72]. Proceedings of the 148th Annual Meeting Psychiatric Association; 1995 May 20-25; Miami, 73
86. Holland D. An observation of the effect of sertraline on breast milk supply. Aust N Z J Psychiatry 2000; 34 (6): 1032
87. Pearlstein YB, Zrtonick C, Battle CL, et al. Patient choice of treatment for postpartum depression. Arch Women's Ment Health 2006; 9: 303-8
88. Piontek CM, Wisner KL, Perel JM, et al. Serum fluvoxamine levels in breastfed infants. J Clin Psychiatry 2001; 62 (2): 111-3
89. Kristensen JH, Hackett P, Kohan R, et al. The amount of fluvoxamine in milk is unlikely to be a cause of adverse effects in breastfed infants. J Hum Lact 2002; 18 (2): 139-43
90. Yoshida K, Smith B, Kumar RC. Fluvoxamine in breast-milk and infant development. Br J Pharmacol 1997; 44 (2): 210-1
91. Hägg S, Granberg K, Carleborg L. Excretion of fluvoxamine into breast milk. Br J Pharmacol 2000; 49 (3): 286-8
92. Wright S, Dawling S, Ashford JJ. Excretion of fluvoxamine in breast milk [letter]. Br J Clin Pharmacol 1991; 31: 209
93. Gentile S. Quetiapine-fluvoxamine combination during pregnancy and while breastf feeding [letter]. Arch Women's Ment Health 2006; 9 (3): 15
94. Ilett KF, Kristensen JH, Hackett LP, et al. Distribution of venlafaxine and its O-desmethyl metabolite in human milk and their effects in breastfed infants. Br J Clin Pharmacol 2002 Jan; 53 (1): 17-22
95. Ilett KF, Hackett LP, Dushi LJ, et al. Distribution and excretion of venlafaxine and O-desmethylvenlafaxine metabolite in human milk. Br J Clin Pharmacol 1998; 45: 459-62
96. Hendrick V, Altshuler L, Wertheimer A, et al. Venlafaxine and breastfeeding [letter]. Am J Psychiatry 2001; 158 (12): 2089-90
97. Bennet PN. Use of the monographs on drugs. In: Bennet PN, editor. Drug and human lactation. 2nd ed. Amsterdam: Elsevier, 1996: 67-74
98. Koren G, Moretti M, Kapur B. Can venlafaxine in breast milk attenuate the norepinephrine and serotonin reuptake neonatal withdrawal syndrome? J Obstet Gynaecol Can 2006; 28 (4): 299-31
99. Data on file, Lilly Research Laboratories
100. Briggs GG, Samson JH, Ambrose PJ, et al. Excretion of bupropion in breast milk. Ann Pharmacother 1993; 27 (4): 431-3
101. Baab SW, Peindl K, Piontek CM, et al. Serum bupropion levels in 2 breastfeeding mother-infant pairs. J Clin Psychiatry 2002; 63: 910-1
102. Haas JS, Kaplan C, Barenboim D, et al. Bupropion in breast milk: an exposure assessment for potential treatment to prevent post-partum tobacco use. Tob Control 2004; 13 (1): 52-6
103. Chaudron LH, Schoenecker CJ. Bupropion and breastfeeding: a case of possible infant seizures [letter]. J Clin Psychiatry 2004; 65 (2): 881-2
104. Bupropion: seizures in an infant exposed through breast-feeding. Prescrire Int 2005; 14 (78): 144
105. Dodd S, Maguire KP, Burrows GD, et al. Nefazodone in the breast milk of nursing mothers: a report of two patients [letter]. J Clin Psychopharmacol 2000; 20 (6): 717-8
106. 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
107. Aichhorn W, Whitworth AB, Weiss U, et al. Mirtazapine and breast-feeding [letter]. Am J Psychiatry 2004; 161 (12): 2325
108. Kristensen JH, Ilett KF, Rampono J, et al. Transfer of antidepressant mirtazapine into breastmilk. Br J Pharmacol. Epub 2006 Sep 13
109. Hackett PL, Ilett KF, Rampono J, et al. Transfer of reboxetine into breastmilk, its plasma concentrations and lack of adverse effects in the breastfed infants. Eur J Pharmacol 2006; 62: 633-8
110. Warner A. Drug use in the neonate: interrelationships of pharmacokinetics, toxicity, and biochemical maturity. Clin Chem 1986; 32: 721-7
111. Nurnberg HG. Breast feeding and psychotropic agents. Am J Psychiatry 1981; 138: 120-1
112. Tsintis P, La Mache F. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications. Drug Saf 2004; 27 (8): 509-17
113. Maciag D, Simpson KL, Coppinger D, et al. Neonatal antidepressant exposure has lasting effects on behavior and serotonin circuitry. Neuropsychopharmacol 2006; 31 (1): 47-57
114. Gentile S. SSRIs in pregnancy and lactation. Emphasis on neurodevelopmental outcome. CNS Drugs 2005; 19 (7): 623-33
115. Wisner KL, James MS, Perel JM, et al. Antidepressant treatment during breast-feeding. Am J Psychiatry 1996; 153 (9): 1132-7
116. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30 (82): 239-45
117. Hale TW. Medications and mothers' milk (10th ed.). Amarillo (TX): Pharmasoft, 2002
118. Eberhard-Gran M, Eskild A, Opjordsmoen A. Use of Psychotropic Medications in Treating Mood Disorders during Lactation: Practical Recommendations. CNS Drugs 2006; 20 (3): 187-98
119. Blier P. Pregnancy, depression, antidepressants and breastfeeding. J Psychiatry Neurosci 2006; 31 (4): 226-8