Reactions 1263 - 1 Aug 2009

SClomipramine

Neonatal inadaptation syndrome in a neonatefollowing in utero exposure: case report

Neonatal inadaptation syndrome associated withhypotonia and hypoventilation occurred in a femaleneonate following in utero exposure to clomipramine.

The baby’s mother was treated with clomipramine[Anafranil] 25 mg/day [therapeutic indication not stated],which was started before she became pregnant andcontinued during her whole pregnancy. When the babywas born (at term), she showed signs of hypotonicity andhypoventilation.

The baby required continuous positive airway pressureventilation for about an hour and naloxone. The mothercontinued receiving clomipramine after delivery and thebaby was entirely breastfed. Clomipramine concentrationsin the baby’s plasma and breast milk were measured whenshe was 33 days old. She did not exhibit any specific clinicalsigns. Results showed that concentrations of clomipramineand its active metabolite desmethylclomipramine wereundetectable in the infant’s plasma. In contrast, in breastmilk, the concentration of clomipramine was 55.1 µg/L anddesmethylclomipramine was below the limit ofquantification (50 µg/L).

Author comment: Chronic exposure of the infant toclomipramine taken by her mother during the entirepregnancy resulted in neurological adverse effects(hypotonicity) and respiratory adverse effects (hypoventilation)in this infant immediately after birth.Khachman D, et al. Clomipramine in breast milk: a case study. Journal dePharmacie Clinique 28: 33-38, No. 1, Jan-Mar 2009 [French; summarised from anEnglish translation] - France 801146634

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Reactions 1 Aug 2009 No. 12630114-9954/10/1263-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved