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The first controlled study of pregnant women taking the newer SSRI's showed no additional risk to the fetuses, according to a study published in the February 25 Journal of the American Medical Association.
"The new SSRI's, fluvoxamine, paroxe-tine, and sertraline, do not appear to increase the risk of birth defects when used in recommended doses," write the authors.
The findings are significant because an estimated 8 percent to 20 percent of all women suffer from depression, and more than half of all pregnancies are unplanned. Thus, the safety of fetuses unintentionally exposed to SSRI's has become a concern, according to the authors.
Researchers in Canada and the United States conducted a nine-center prospective study of 534 pregnant women. Half had been exposed to an SSRI during the first trimester, and the remaining half (the control group) were never exposed to an SSRI.
Of the 267 women on SSRI's, 147 used sertraline, 97 used paroxetine, and 26 used fluvoxamine. One woman used both sertraline and fluvoxamine, and two women used paroxetine and sertraline in the first trimester. Forty-nine of the 267 women exposed to an SSRI used the drug throughout pregnancy.
Cohort participants consisted of women who contacted one of nine participating centers following exposure to a newer SSRI. They were matched to a randomly selected control group of women who were counseled after reporting exposure to agents that do not cause birth defects, such as dental X-rays and acetaminophen.
Both groups of women were interviewed about six to nine months after delivery.
The researchers found that the pregnancy outcomes for women who took an SSRI throughout pregnancy did not differ from those who took the drug only during the first trimester. Further, exposure to SSRI's was not associated with increased risk for major congenital malformations or higher rates of miscarriages, stillbirths, or premature births.
The authors conclude, "Our results confirm previous animal experiments showing that when used in the recommended doses, the new SSRI's do not appear to increase the risk of congenital malformations.
"Moreover, all measured pregnancy outcomes are well within those reported in the general population."