The Basics

What is Clomipramine?

Tricyclic antidepressant that is used to treat symptoms of obsessive-compulsive disorder (OCD), such as recurrent thoughts or feelings and repetitive actions.

Brand names for Clomipramine

Anafranil

How Clomipramine is classified

Antidepressive Agents, Antidepressive Agents (Tricyclic)

Clomipramine During Pregnancy

Clomipramine 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 Clomipramine while pregnant

No teratogenic effects were observed in studies performed in rats and mice at doses up to 100 mg/kg, which is 24 times the maximum recommended human daily dose (MRHD) on a mg/kg basis and 4 times (rats) and 2 times (mice) the MRHD on a mg/m² basis. Slight nonspecific embryo/fetotoxic effects were seen in the offspring of treated rats given 50 and 100 mg/kg and of treated mice given 100 mg/kg. There are no adequate or well-controlled studies in pregnant women. Withdrawal symptoms, including jitteriness, tremor, and seizures, have been reported in neonates whose mothers had taken Anafranil until delivery. Anafranil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Clomipramine While Breastfeeding

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

Limited evidence indicates that use of clomipramine during breastfeeding is acceptable. For women who were taking clomipramine during pregnancy, the amount of drug in breastmilk may be insufficient to prevent neonatal withdrawal symptoms in breastfed infants. For use as an antidepressant, clomipramine may be less desirable than other antidepressants that have been studied more thoroughly.

Maternal / infant drug levels

Limited evidence indicates that use of clomipramine during breastfeeding is acceptable. For women who were taking clomipramine during pregnancy, the amount of drug in breastmilk may be insufficient to prevent neonatal withdrawal symptoms in breastfed infants. For use as an antidepressant, clomipramine may be less desirable than other antidepressants that have been studied more thoroughly.

Possible effects of Clomipramine on milk supply

Clomipramine has caused increased prolactin levels and galactorrhea in nonpregnant, nonnursing patients.[9][10][11][12] The clinical relevance of these findings in nursing mothers is not known. 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 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.[13] 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.[14] None of the mothers were taking clomipramine.

Possible alternatives to Clomipramine

Fluvoxamine, 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. Schimmell MS, Zylber Katz E, Shaag Y et al. Toxic neonatal effects following maternal clomipramine therapy. Clin Toxicol. 1991;29:479-84. PMID: 1749054
2. Yoshida K, Smith B, Craggs M et al. Investigation of pharmacokinetics and possible adverse effects in infants exposed to tricyclic antidepressants in breast-milk. J Affective Disord. 1997;43:225-37. PMID: 9186793
3. Khachman D, Gandia P, Gaillard MA et al. Clomipramine in breast milk: a case study. J Pharm Clin. 2009;28:33-8.
4. Wisner KL, Perel JM, Foglia JP. Serum clomipramine and metabolite levels in four nursing mother-infant pairs. J Clin Psychiatry. 1995;56:17-20. PMID: 7836334
5. Misri S, Sivertz K. Tricyclic drugs in pregnancy and lactation: a preliminary report. Int J Psychiatry Med. 1991;21:157-71. PMID: 1894455
6. Buist A, Janson H. Effect of exposure to dothiepin and northiaden in breast milk on child development. Br J Psychiatry. 1995;167:370-3. PMID: 7496646
7. Nulman I, Rovet J, Stewart DE et al. Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective, controlled study. Am J Psychiatry. 2002;159:1889-95. PMID: 12411224
8. Ter Horst PG, van der Linde S, Smit JP et al. Clomipramine concentration and withdrawal symptoms in 10 neonates. Br J Clin Pharmacol. 2012;73:295-302. PMID: 21801198
9. Anand VS. Clomipramine-induced galactorrhoea and amenorrhoea. Br J Psychiatry. 1985;147:87-8. PMID: 4063616
10. Fowlie S BJ. Hyperprolactinaemia and nonpuerperal lactation associated with clomipramine. Scott Med J. 1987;32:52. PMID: 3602989
11. 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
12. Baumgartner A, Graf KJ, Kurten I. Prolactin in patients with major depressive disorder and in healthy subjects. II. Longitudinal study of basal prolactin and post-TRH-stimulated prolactin levels. Biol Psychiatry. 1988;24:268-85. PMID: 3135848
13. 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
14. 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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