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Conditions in Pregnancy: Newborns may suffer paroxetine withdrawal

By Jenny Manzer

TORONTO – Babies exposed to paroxetine close to birth have a high rate of complications—which could mean they go through withdrawal, a cohort study from the Hospital for Sick Children suggests.
   The team found babies exposed to paroxetine (Paxil) in the third trimester showed symptoms at birth, such as respiratory distress, that could be part of a discontinuation syndrome, said co-investigator Dr. Gideon Koren.
   "Basically, one day they wake up to the world, they see light, and there is no paroxetine any more," said Dr. Koren, who directs the Motherisk program at Sick.Kids.
   Dr. Koren and colleagues set out to determine if babies exposed to paroxetine experienced their own version of the discontinuation syndrome described in adults.
   They prospectively compared the perinatal outcomes of 55 women who took paroxetine in the third trimester to healthy controls. There were two comparison groups, one of 27 women who took paroxetine during the first and second trimester, and another one of 27 women who did not take paroxetine.
   The groups were matched for variables such as maternal age, parity and social drug use. Women using any drugs known to cause withdrawal-type symptoms, such as opioids, were excluded.
   Results showed 12 babies born to women who used the drug in the third trimester had signs of fetal distress, requiring intensive management and prolonged hospitalization. The complications included nine cases of respiratory distress, two of hypoglycemia and one of jaundice.
   In contrast, there were only three cases of complications in the control group.
   The symptoms in the babies born to women in the study group disappeared within one to two weeks, said Dr. Koren, a professor of pediatrics and pharmacology at the University of Toronto. There also appeared to be no underlying pathology causing the complications, he said, adding resolution of symptoms would not be expected so quickly if that were the case.
   He said they have no evidence babies exposed to paroxetine late in pregnancy experienced lasting damage, and months of followup have revealed no malformations. "They were at home thriving, and doing well."
   Use of paroxetine in pregnancy has not been linked to birth defects, he noted.
   "That's why if you put all these pieces together, it may reflect adult discontinuation syndrome."
   The study group also had a significantly higher proportion of babies born prematurely, at 20%, compared to just 3.7% in controls.
   Dr. Koren said more research is needed to determine what might be triggering the premature births, but that maternal depression, as well as the medication, could be a factor.
   "A mother who is still very depressed around birth, that still needs therapy, may be different in many other elements than a mom who could stop the drug in the second trimester," he said.
   The Motherisk team's most recent results, presented at the Pediatric Academic Societies meeting, supplement their previous findings on Selective Serotonin Reuptake Inhibitors (SSRIs).
   In 1998, they concluded SSRIs, including paroxetine, were safe for use during the first trimester of pregnancy.
   University of British Columbia researcher Dr. Shaila Misri, who studies paroxetine in pregnancy, said she and her colleagues are extremely concerned by the Toronto findings, which are at odds with their own.
   In 2000, the UBC team presented results suggesting paroxetine was the best choice of SSRIs for use during pregnancy and breastfeeding.
   They found paroxetine appeared to be cleared more quickly by the neonate, and was also less evident in breast milk than other antidepressants.
   Dr. Misri, a psychiatrist and obstetrician-gynecologist, said the Toronto study lacks conclusive evidence of paroxetine being associated with withdrawal symptoms in neonates.
   "The withdrawal symptoms would happen, if they did, in all populations—which we haven't seen," argued Dr. Misri.
   Hypoglycemia and jaundice seen over a two-week period could be due to any number of factors, she added.
   "As far as the preterm labour is concerned, given the number of women, I think again it is too premature to come to any conclusions—so we are very concerned about conclusions like these," said Dr. Misri, who is set to publish more data supporting use of paroxetine in pregnancy.."It is, I think, a very good medication. We have evidence to that effect."
   A previous prospective cohort study, led by the California Teratogen Information Service and published last June in.Teratology, also found a greater risk for preterm birth associated with paroxetine use late in pregnancy.
   The team, noted, however, that their 100 paroxetine users tended to engage in more risky behaviours than controls.
   Dr. Koren stressed the importance of continuing to treat depression in pregnancy, and said while paroxetine use should not be ruled out, physicians should watch for problems in babies exposed near term.
   "The first two weeks of life can be quite stormy. The child should be looked upon very closely," he said.

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