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Motherisk Newsletters: Summer 2002, No. 15

Summer 2002, No. 15


Exposure during pregnancy to the antidepressant drug paroxetine is associated with a high rate of neonatal complications

Motherisk researchers 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 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, twelve 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 non-teratogenic 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 among infants exposed to paroxetine during the third trimester may, at least in part, be associated with the maternal psychiatric disorders," said Dr. Adriana Costei, the study's co-author and presenter at the Pediatric Academic Societies Annual Meeting. "However, half of our comparison group was comprised of mothers who had similar conditions and who received the drug only during the first and second trimester."

"Infants exposed to the drug only during the first and second trimesters did not exhibit neonatal complications or higher rates of prematurity, as compared to 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 the Motherisk Program, and a professor of Paediatrics, Pharmacology, and Medicine and Medical Genetics at the University of Toronto.

This research was supported by The Hospital for Sick Children Foundation and the Research Leadership for Better Pharmacotherapy during Pregnancy and Lactation.

Researchers find that pregnant women with untreated epilepsy are not at an increased risk of having an infant born with a birth defect

Motherisk researchers have concluded that there is no evidence of an increased chance of major birth defects occurring in the offspring of women with epilepsy who do not take anti-epileptic medications during pregnancy.

The Motherisk study, presented at the Pediatric Academic Societies Annual Meeting in Baltimore, Maryland, conducted a meta-analysis of published studies reporting pregnancy outcome among women of untreated epilepsy compared with healthy controls. It is widely believed that women with epilepsy have higher than standard risk for giving birth to a child with malformations, independent of the effects of anti-epileptic drugs (AEDs). This research sought to determine through a systematic review of studies on the subject the reality behind this perception.

Ten papers, six cohort studies and four case-controlled studies met the inclusion criteria and were included in the meta-analysis. The risk for congenital malformations in offspring of women with untreated epilepsy was found to be not significantly higher than in healthy controls. In contrast, the offspring of women treated with anti-epileptic drugs had higher incidence of major malformations than healthy controls.

"The association of fetal malformations with untreated maternal epilepsy is controversial. From this research we found no evidence of increased risk for major malformations in offspring of women who did not take anti-epileptic medications during gestation," said Dr. Irena Nulman, co-author and presenter of the study at the Pediatric Academic Societies Annual Meeting.

"This information is reassuring for women with epilepsy who do not need to take AEDs. It is also important for women with specific types of epilepsy and their physicians, who may choose to discontinue AEDs during the first trimester in order to reduce risks of major malformations," said Dr. Gideon Koren, the study's principal investigator, director of the Motherisk Program, and a professor of Paediatrics, Pharmacology, and Medicine and Medical Genetics at the University of Toronto.

The teratogenic risk associated with AEDs appears to be four to eight per cent, roughly two to three times greater than the general obstetric population. Presently, there is no consensus regarding which anticonvulsant drug is the safest for the pregnant mother's unborn child.

This research is supported by The Hospital for Sick Children Foundation and the Research Leadership in Better Pharmacotherapy during Pregnancy and Lactation.

The use of aspirin in pregnancy investigated

Dr. Eran Kozer of the Motherisk Program and colleagues analyzed 22 studies investigating the safety of aspirin during pregnancy. Dr. Kozer reported their findings at the annual meeting of the American Society of Clinical Pharmacology and Therapeutics (ASCPT) in March. "In the eight studies reporting an overall risk, the risk of congenital malformations in offspring of women exposed to aspirin was not significantly higher than that in controls," he reported. Aspirin is a nonsteroidal anti-inflamatory drug (NSAID).

The data indicated that when compared to women who did not take aspirin during pregnancy, women who did take it were about twice as likely to have a baby with gastroschisis. Gastroschisis is a hole in the abdominal wall through which the intestines protrude. Dr. Kozer stressed, however, that with an occurrence rate of approximately 1case in 15,000, the absolute risk of this defect is extremely low.

However, Dr. Kozer also pointed out that the "newer selective NSAIDs might be associated with a slightly increased risk of pregnancy loss, although this needs to be confirmed." Pregnant women are also advised to avoid aspirin because it can increase the risk of bleeding or interfere with labor and delivery.

Proton pump inhibitors may be relatively safe during pregnancy

Motherisk Assistant Director, Myla Moretti, and colleagues followed 77 women who were exposed to proton pump inhibitors (PPIs) during pregnancy. They also conducted an analysis including their data and four additional studies. Ms. Moretti reported their findings at the ASCPT annual meeting in March.

PPIs are used to treat ulcers and heartburn by reducing the production of acid in the stomach.

The analysis included over 600 pregnant women who took PPIs. Researchers found no difference in the rate of major birth defects, gestational age at delivery or birth weight between the PPI- exposed and unexposed control groups. The PPI, omeprazole, was used in over 90% of the cases. Lansoprazole and pantoprazole were also used.

"PPIs are becoming more popular, especially for the treatment of heartburn and ulcers in pregnancy," Ms. Moretti stated. She added that for pregnant women the benefits of the drugs may outweigh the potential risks if they are needed to treat gastrointestinal disease.

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