Document Detail

Perinatal outcome following third trimester exposure to paroxetine.
MedLine Citation:
PMID:  12413342     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Paroxetine hydrochloride is commonly used for maternal depression, panic disorder, and obsessive-compulsive disorder. The drug readily crosses the human placenta. Although it does not appear to increase teratogenic risk, there have been case reports of neonatal withdrawal. Symptoms were described soon after birth and lasted up to 1 month. OBJECTIVE: To investigate whether there is a clinically important discontinuation syndrome in neonates exposed to paroxetine in utero. METHODS: Prospective, controlled cohort study. PATIENTS: Fifty-five pregnant women counseled prospectively by the Motherisk program in Toronto, Ontario, regarding third-trimester exposure to paroxetine and their infants were included in the study group. Pregnant women who discontinued paroxetine before the third trimester or those receiving other drugs known to cause withdrawal-type symptoms, such as opioids or benzodiazepines, were excluded. A comparison group of 27 women using paroxetine during the first or second trimester and 27 women using nonteratogenic drugs were matched for maternal age, gravity, parity, social drug use, and nonteratogenic drug use. RESULTS: Of the 55 neonates exposed to paroxetine in late gestation, 12 had complications necessitating intensive treatment and prolonged hospitalization. The most prevalent clinical picture was respiratory distress (n = 9), followed by hypoglycemia (n = 2), and jaundice (n = 1). The symptoms disappeared within 1 to 2 weeks. In the comparison group, only 3 infants experienced complications (P =.03). In logistic regression, only third-trimester exposure to paroxetine was associated with neonatal distress (odds ratio, 9.53; 95% confidence interval, 1.14-79.3). CONCLUSION: When used near term, paroxetine is associated with a high rate of neonatal complications, possibly caused by its common discontinuation syndrome.
Adriana Moldovan Costei; Eran Kozer; Tommy Ho; Shinya Ito; Gideon Koren
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of pediatrics & adolescent medicine     Volume:  156     ISSN:  1072-4710     ISO Abbreviation:  Arch Pediatr Adolesc Med     Publication Date:  2002 Nov 
Date Detail:
Created Date:  2002-11-04     Completed Date:  2002-12-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9422751     Medline TA:  Arch Pediatr Adolesc Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1129-32     Citation Subset:  AIM; IM    
the Motherisk program, Division of Clinical Pharmacology/Toxicology, the Hospital for Sick Children, Toronto, Ontario, Canada.
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MeSH Terms
Case-Control Studies
Hypoglycemia / chemically induced
Infant, Newborn
Jaundice / chemically induced
Maternal-Fetal Exchange*
Neonatal Abstinence Syndrome / etiology*
Paroxetine / adverse effects*
Pregnancy Trimester, Third
Prospective Studies
Respiratory Distress Syndrome, Newborn / chemically induced*
Serotonin Uptake Inhibitors / adverse effects*
Reg. No./Substance:
0/Serotonin Uptake Inhibitors; 61869-08-7/Paroxetine
Comment In:
Arch Pediatr Adolesc Med. 2003 Jun;157(6):601   [PMID:  12796244 ]

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