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Brunilda Nazario, MD
Jan. 1, 2013 -- Antidepressant use during pregnancy, long debated for its safety, is linked with a higher overall risk of stillbirth and newborn death. Now, a new study shows that risk may not be warranted.
"After taking maternal characteristics such as smoking and maternal age into account, as well as previous hospitalization for psychiatric disease ... there was no association between SSRI (antidepressants) and stillbirth and infant [death]," says researcher Olof Stephansson, MD, PhD, of the Karolinksa Institutet in Stockholm.
The Swedish study included more than 1.6 million births in five Nordic countries. Nearly 30,000 of the women had filled a prescription for an SSRI (selective serotonin reuptake inhibitor) during pregnancy.
But a U.S.-based expert has some concerns about the study.
"This study looked at information on dispensed drugs, not ingested drugs, and these numbers are often quite different," says Adam Urato, MD, assistant professor of obstetrics and gynecology at Tufts University School of Medicine.
That could result in inaccurate findings, he says. "I don't find the study results particularly reassuring," he says.
Up to 19% of pregnant women have depression during pregnancy, according to the researchers. The depression itself is linked with ill effects, including an increased risk of early delivery, which in turn may cause harm to the newborn.
The new research was funded by the Swedish Pharmacy Company.
The study is published in the Journal of the American Medical Association.
Previous research about SSRI use during pregnancy has suggested it may be linked with an increased risk of prematurity, stillbirths, and birth defects. Some studies show an increased risk of miscarriage and other problems.
The three areas the researchers focused on were stillbirths and newborn and infant deaths. The researchers compared the birth outcomes for the women who took SSRIs and those who did not from 1996 through 2007. They got information on the use of SSRIs from prescription registries.
This type of antidepressant is the most-often prescribed for depression during pregnancy, the researchers say.
Overall, more than 6,000 babies were stillborn. More than 3,600 died as newborns, and another 1,578 died later, from ages 28 days old to 364 days old.
Women registered with an SSRI prescription had higher stillbirth rates -- 4.62 for every 1,000, compared to 3.69 per 1,000 for women who were not on the drugs.
Women registered with an SSRI prescription also had a higher risk of their infants dying at ages 28 days to just under a year.
The rates of early newborn death were similar between groups.
Next, the researchers took into account factors that could have played a role in stillbirths or infant deaths. These included the mother's age, cigarette smoking, and the severity of the mother's psychiatric disease.
When they took those risk factors into account, they found no substantial link between the antidepressant use and risks of stillbirth or death.
Even so, the researchers say women need to discuss SSRI use with their doctor to weigh the pros and cons. "Always discuss medication for depression with your obstetrician in early pregnancy for advice," Stephansson says.
The inexact information about who exactly took the SSRIs is a problem, Urato says. "When exposure information is inexact ... the result is often that we do not find evidence of harm from the drug," he says, although harm may exist.
A woman prescribed an SSRI who does not take it and then has a good birth outcome is classified as taking an SSRI, contributing to the finding of no harm, he says.
Urato points to other research, including links with SSRI use and miscarriage, birth defects, and other problems.
"Depressed pregnant women need good care and treatment, but medication is not the only option for treatment," he says.
In 2009, the American Psychiatric Association and the American College of Obstetricians and Gynecologists issued a joint report on treatment recommendations for depression during pregnancy. It suggests discussing the risks and benefits of antidepressants during pregnancy. It also suggests that psychotherapy may help women who prefer to avoid the drugs.
SOURCES:Olof Stephansson, MD, PhD, researcher, Karolinska Institutet, Stockholm.Adam C. Urato, MD, assistant professor of obstetrics & gynecology, Tufts University School of Medicine; chairman, depart of obstetrics & gynecology, MetroWest Medical Center, Framingham, Ma.Stephansson, O. Journal of the American Medical Association, Jan. 2, 2013.
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