Researchers at Toronto's Hospital for Sick Children (HSC) have concluded that exposure during pregnancy to paroxetine (Paxil), a drug commonly used to treat depression, panic, and obsessive-compulsive disorders, is associated with a high rate of neonatal complications when used near term.
The Motherisk study, presented at the Pediatric Academic Societies Annual Meeting in Baltimore, Maryland, compares the perinatal outcome of infants exposed to paroxetine in utero during the third trimester of pregnancy to infants exposed to the drug only during the first and second trimesters of pregnancy, and also to infants with no exposure to the drug. While paroxetine does not increase teratogenic (relating to or causing developmental malformations) risk, case reports of neonatal withdrawal symptoms prompted researchers to investigate whether, similar to adults, discontinuation syndrome can occur.
The study ascertained that among the 55 pregnant women exposed to paroxetine during the third trimester, 12 infants had neonatal complications that necessitated prolonged hospitalizations. The prevalent clinical picture was respiratory distress (experienced by nine infants), hypoglycemia (experienced by two infants), and one infant with jaundice.
In contrast, of the comparison group of 27 women using paroxetine during the first or second trimester, and 27 women using nonteratogenic drugs, only three babies had neonatal complications. Two of the infants were exposed to paroxetine in trimesters one and two and had respiratory distress and meconium aspiration. The third infant had jaundice and was not exposed to paroxetine during pregnancy.
"It may be argued that the high rate of adverse neonatal events, especially during breastfeeding, among infants exposed to paroxetine during the third trimester may, at least in part, be associated with the maternal psychiatric disorders associated with it," said Dr. Adriana Costei, the study's coauthor and presenter at the Pediatric Academic Societies Annual Meeting. "However, half of our comparison group was composed of mothers who had similar conditions and who received the drug only during the first trimester and second."
"Infants exposed to the drug only during the first and second trimesters did not exhibit neonatal complications or higher rates of prematurity, as did those exposed in the third trimester. This highly suggests that paroxetine exposure near term may compromise fetal and neonatal health. The fact that the adverse events were brief, without other underlying pathology, further supports drug exposure as the mechanism for the adverse effects," Costei added.
"This study is the first to highlight higher rates of perinatal complications with this drug. This means that babies exposed to paroxetine near term will need special, high-risk follow-up, to prevent long-term risks," said Dr. Gideon Koren, the study's principal investigator, director of HSC's Motherisk Program, and a professor of pediatrics, pharmacology, and medicine and medical genetics at the University of Toronto. This article was prepared by Pain & Central Nervous System Week editors from staff and other reports.
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