Respiratory distress, low blood sugar and jaundice are among the complications found in babies when their mothers continue taking paroxetine -- Paxil's generic name -- in the third trimester of pregnancy, says a new Canadian study.
Paxil is often prescribed to treat depression, panic and obsessive-compulsive disorders.
"What we found was that [among] women who use paroxetine through pregnancy until birth, their offspring are more likely to have several stormy weeks at infancy," says Dr. Gideon Koren, study author and director of the Motherisk program at the Hospital for Sick Children in Toronto.
Motherisk is a consultation service for pregnant or lactating women concerned about the risks posed by drugs, chemicals, infection, disease and radiation exposure.
Many of these babies have to stay in the hospital for two to three weeks after they're born, but they suffer no long-term health effects. The drug does not increase the risk of physical deformities, says Koren, who is also professor of pediatrics, pharmacology, medicine and medical genetics at the University of Toronto.
The study found problems in 12 babies born to 55 women who took Paxil during all trimesters of their pregnancy. Nine of the babies had respiratory distress, two had hypoglycemia (low blood sugar), and one had jaundice.
The authors compared that to a group of 54 women, 27 of whom took Paxil only during the first or second trimester. In that group, two babies suffered similar complications.
The other 27 women in the comparison group didn't take Paxil, but took other kinds of drugs, such as acetaminophen. One baby in that group had jaundice.
Twenty percent of the babies in the study group were born premature, compared to 3.7 percent of the babies in the comparison group.
The study was presented yesterday at the Pediatric Academic Societies Annual Meeting in Baltimore.
Those findings seem to indicate that taking Paxil in the third trimester could affect the health of newborns, who experience a form of withdrawal, Koren says.
"What you have here is a baby in mom's womb who is used to the drug. Then suddenly he's not connected to that drug anymore," he says.
While the babies do experience a kind of withdrawal, it isn't the same as withdrawal from narcotics or alcohol.
"Typical withdrawal includes a lot of things you don't see here, such as sweating, gastrointestinal changes and convulsions," Koren says.
These babies suffer what is called discontinuation syndrome. "It doesn't involve actual addiction," Koren says.
Paxil is a selective serotonin reuptake inhibitor (SSRI), a drug that acts in the brain on a chemical messenger called serotonin. Previous research shows that adults who take Paxil suffer more discontinuation syndrome compared to people who take other SSRIs, Koren says.
"So, what we see in the children reflects what we see in adults," he says.
He says there isn't enough data from this small study to suggest pregnant women should avoid Paxil, and take other drugs to treat their depression. However, the study is a caution to doctors to be aware of these potential complications in newborns.
However, a women's health specialist says the findings indicate doctors should avoid prescribing Paxil to pregnant women in the last three months of pregnancy.
This study provides vital new information about Paxil, says Dr. Donna Stewart, professor and chairwoman of women's health at University Health Network and University of Toronto.
"It is clear from Koren's recent study that the earlier reassurances about paroxetine use in pregnancy were premature, and it highlights the importance of careful analysis of the timing of drug administration in pregnancy," Stewart says.
She says there's need for a larger study that follows children exposed to antidepressants during pregnancy to monitor their development into adolescence.
Antidepressant treatment in pregnant women is a risk-benefit decision, "as untreated depression may result in poor prenatal care, deficient diet and self-care, substance abuse, smaller infant weights, prematurity and possible risks of maternal suicide," Stewart says.
The maker of Paxil, GlaxoSmithKline, did not return calls for comment.
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