ter Horst, Peter G. J.;
van der Linde, Susanne;
Smit, Jan Pieter;
den Boon, Jan;
van Lingen, Richard A.;
Jansman, Frank G. A.;
De Jong‐van den Berg, Lolkje T. W.;
Wilffert, Bob
Clomipramine concentration and withdrawal symptoms in 10 neonates
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Medientyp:
E-Artikel
Titel:
Clomipramine concentration and withdrawal symptoms in 10 neonates
Beteiligte:
ter Horst, Peter G. J.;
van der Linde, Susanne;
Smit, Jan Pieter;
den Boon, Jan;
van Lingen, Richard A.;
Jansman, Frank G. A.;
De Jong‐van den Berg, Lolkje T. W.;
Wilffert, Bob
Erschienen:
Wiley, 2012
Erschienen in:British Journal of Clinical Pharmacology
Beschreibung:
<jats:p><jats:bold>WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT</jats:bold></jats:p><jats:p>• Antidepressants are associated with withdrawal symptoms after <jats:italic>in utero</jats:italic> exposure.</jats:p><jats:p>• Half‐life of clomipramine in neonates is prolonged compared with that in adults.</jats:p><jats:p><jats:bold>WHAT THIS STUDY ADDS</jats:bold></jats:p><jats:p>• We present 10 cases of neonates exposed <jats:italic>in utero</jats:italic> to clomipramine, with detailed information about withdrawal symptoms and pharmacokinetics.</jats:p><jats:p>• There is a high and severe complication rate in our cohort regarding the mother and the neonate.</jats:p><jats:p><jats:bold>AIM</jats:bold> After <jats:italic>in utero</jats:italic> exposure to tricyclic antidepressants, neonatal withdrawal symptoms have been reported with an estimated incidence between 20 and 50%; however, few data are available for clomipramine. This could also be the case for neonatal pharmacokinetic clomipramine parameters and so this study was set up.</jats:p><jats:p><jats:bold>METHODS</jats:bold> Babies exposed to clomipramine <jats:italic>in utero</jats:italic> were included in an observational study, approved by the local ethics committee, after written informed consent. Withdrawal symptoms were scored at 12, 24 and 48 h after birth using the Finnegan score. Plasma concentrations were determined using an in‐house‐developed, validated liquid chromatography with mass detection (LC‐MSMS) method at 0, 12, 24 and 48 h after birth.</jats:p><jats:p><jats:bold>RESULTS</jats:bold> We found that three of 11 pregnancies were complicated with pre‐eclampsia. Ten neonates were observed for clomipramine withdrawal symptoms. The observed withdrawal symptoms were too short a period of sleep after feeding (6), poor feeding (3), mild to severe tremors (6), hyperactive Moro reflex (3) and respiratory rate >60 breaths min<jats:sup>−1</jats:sup>. Serious withdrawal reactions, such as tachycardia and cyanosis, were seen. We calculated a half‐life value of 42 ± 16 h for clomipramine in neonates. Only a weak correlation was found between withdrawal reactions and clomipramine plasma concentration or desmethylclomipramine plasma concentration.</jats:p><jats:p><jats:bold>CONCLUSIONS</jats:bold> In neonates, clomipramine is eliminated with a half‐life value of 42 h, compared with 20 h in adults. In two of 10 neonates, tachycardia and cyanosis were seen as serious withdrawal symptoms after maternal use of clomipramine.</jats:p>