Beware Third Trimester Exposure to Paroxetine

Laurie Barclay, MD

November 22, 2002

Nov. 22, 2002 — Third trimester exposure to paroxetine may cause neonatal complications due most likely to withdrawal syndrome, according to a report in the November issue of the Archives of Pediatric and Adolescent Medicine.

"Paroxetine hydrochloride (Paxil) is commonly used for maternal depression, panic disorder, and obsessive-compulsive disorder in pregnant women," write Adriana M. Costei, MD, and colleagues from the Hospital for Sick Children in Toronto, Ontario, Canada. "Although the drug does not appear to cause major congenital malformations, its perinatal safety when used in late gestation has not been established."

In this prospective, controlled cohort study, 55 pregnant women counseled prospectively regarding their third-trimester exposure to paroxetine were compared with 27 women using paroxetine during the first or second trimester and with 27 women using nonteratogenic drugs. The groups were matched for maternal age, gravity, parity, social drug use, and nonteratogenic drug use.

Of the 55 neonates exposed to paroxetine in the third trimester, 12 had complications requiring intensive treatment and prolonged hospitalization. These included respiratory distress in nine infants, hypoglycemia in two, and jaundice in one, all of which resolved within one to two weeks. Three infants in the comparison group had complications (P=.03).

Logistic regression revealed that only third-trimester exposure to paroxetine, and not prematurity, maternal smoking, or other confounding factors, was associated with neonatal respiratory distress (odds ratio, 9.53; 95% confidence interval, 1.14-79.3).

"Whether other SSRIs have neonatal toxicity profiles similar to paroxetine's remains to be explored," the authors write. "The unexpected high rates of neonatal complications with paroxetine are biologically consistent with the high rate of discontinuation syndrome with this particular SSRI and also with its being the most pharmacologically specific of the SSRIs. More studies are needed to verify our observations and to better characterize pregnancy outcomes and neonatal response."

Arch Pediatr Adolesc Med. 2002;156:1129-1132

Reviewed by Gary D. Vogin, MD

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