Focusing mainly on depression and anxiety, the study includes such popular drugs such as Paxil, Prozak, and Zoloft.
Paxil does carry a warning advising of possible heart defects in newborns, and that is unlikely to change, however the new studies may be comforting to many women struggling with depression.
Up until recently, it has been a Catch-22 situation- birth defects are bad, but mothers who are depressed and unable to properly care for their newborns are also a risk.
TO make it even more confusing, there had been concerns that the warnings should extend beyond Paxil, and include the entire class of SSRI's ( serotonin-reuptake inhibitors). These studies, which appear in The New England Journal of Medicine, should relieve some of that worry.
"Yeah, there's a risk, but the risk overall is probably pretty small," said Dr. Susan Ramin, obstetrics chairman at the University of Texas Medical School in Houston.
The studies, one from the Centers for Disease Control and the other from Boston University, use a broader number of birth defect than previous research to consider the relation between birth abnormalities and SSRI's. The Boston University study was funded partly from the National Institutes of Health and Paxil maker GlaxoSmithKline PLC.
The studies examined 19,471 newborns with birth defects and 9,952 without and birth defects. Then they considered what SSRI's the mothers in both groups took during the first trimester of pregnancy and mapped the patterns of defects.
Neither study was able to tie SSRI's as a group to either heart defects or most other defects. That reassurance is especially welcome because depressed women tend to worry over their newborns health more so than non-depressed women, said Dr. Stephan Quentzel, a psychiatrist who treats pregnant women at Beth Israel Medical Center in New York City.
Also, a mother's untreated depression can lead to poor care or neglect at home, a weaker bond between mother and baby, and other problems for a newborn. "The fetus and the newborn are almost always worse off if the mom is depressed than if ... exposed to the vast majority of antidepressants," Quentzel said.
Doctors and mothers have been very wary about medications and birth defects since the 1960's scandal of deformed babies in Europe due to Thalidomide. Defects from all causes are expected in about 3 percent of births, which is enough to make many mothers nervous.
The concern about SSRI's grew out of GlaxoSmithKline's own alert in 2005 about possible heart defects in newborns whose mothers took Paxil early in pregnancy. The U.S. Food and Drug Administration added its own warning. Last year, a separate study linked SSRI's taken late in pregnancy to a lung disorder in newborns.
The latest studies do not consider that disorder, known as persistent pulmonary hypertension. But they suggest that the risk of other defects from an SSRI -- even if confirmed -- would add only a fraction of 1 percent to the overall danger, researchers said.
Paxil did appear to triple the risk of a defect in blood flow from the heart, both studies found. But that additional danger would still only be modest, experts said.
The studies further hinted at possible ties between other SSRI's and a handful of other defects, but researchers said the numbers of newborns with specific defects were too small to draw strong conclusions.
"Based on these studies, it's correct to say: no major risk," said Carol Louik, a public health expert who led the Boston study. "I wouldn't say, 'No risk."'
Any woman who is pregnant, or trying to conceive should talk over the potential risks and benefits with their doctors.
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