Document Detail

Severe adverse effects in a newborn with two defective CYP2D6 alleles after exposure to paroxetine during late pregnancy.
MedLine Citation:
PMID:  15570195     Owner:  NLM     Status:  MEDLINE    
Paroxetine, like other SSRIs, is reported not to increase the number of malformations in infants exposed to these drugs in utero. However, late pregnancy exposure to SSRIs sometimes leads to perinatal complications resembling the symptoms seen in serotonergic overstimulation. We report here a case of third trimester paroxetine exposure with adverse birth outcome in a newborn. The clinical symptoms in the infant included severe tremor and rigidity as well as loose stools during the first 4 days of life. Plasma paroxetine concentrations in infant plasma were quite low after birth, but she was genotyped to be a poor metabolizer of CYP2D6, the enzyme catalyzing the metabolism of paroxetine. In accordance with an earlier report, we suggest that even low plasma concentrations of paroxetine may be related to perinatal complications in infants exposed to paroxetine during late pregnancy and that the poor metabolizer genotype of CYP2D6 may be a risk factor for these complications.
Kari Laine; Jaakko Kytölä; Leif Bertilsson
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Publication Detail:
Type:  Case Reports; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Therapeutic drug monitoring     Volume:  26     ISSN:  0163-4356     ISO Abbreviation:  Ther Drug Monit     Publication Date:  2004 Dec 
Date Detail:
Created Date:  2004-11-30     Completed Date:  2005-03-24     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  7909660     Medline TA:  Ther Drug Monit     Country:  United States    
Other Details:
Languages:  eng     Pagination:  685-7     Citation Subset:  IM    
Department of Pharmacology and Clinical Pharmacology, University of Turku, Turku, Finland.
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MeSH Terms
Cytochrome P-450 CYP2D6 / genetics*
Infant, Newborn
Nervous System Diseases / chemically induced,  diagnosis,  enzymology*,  genetics*
Paroxetine / adverse effects*
Prenatal Exposure Delayed Effects*
Grant Support
Reg. No./Substance:
61869-08-7/Paroxetine; EC P-450 CYP2D6
Comment In:
Ther Drug Monit. 2006 Feb;28(1):142-3; author reply 143   [PMID:  16418711 ]
Ther Drug Monit. 2006 Feb;28(1):142; author reply 143   [PMID:  16418712 ]
Ther Drug Monit. 2005 Oct;27(5):683   [PMID:  16175145 ]

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