The study conducted by CDC looked at of 9,622 infants with major birth defects and 4,092 infants without major birth defects, finding no significant links between SSRI use in early pregnancy and congenital heart defects or other birth complications. Researchers did find 2.5 times more cases of three rare birth defects among infants born to SSRI users, but researchers said the link had not been seen in previous studies and needs to be confirmed by further research. About 39 women in the study reported being depressed during pregnancy, and all but five of those women had taken an SSRI, according to USA Today. The study did not examine the effects of untreated depression compared with depression treated with SSRIs.
For the study conducted by Slone, researchers compared SSRI use in the first trimester of pregnancy among 9,849 women whose infants had birth defects with 5,860 women whose infants did not have birth defects. The study did not find an increased risk of birth defects among infants whose mother had taken SSRIs, USA Today reports (Rubin, USA Today, 6/28).
According to Bloomberg/Baltimore Sun, the studies found that the overall risk of having an infant with a birth defect increased by less than 1% for women taking SSRIs during pregnancy (Bloomberg/Baltimore Sun, 6/28). Both studies found that infants born to women who took GlaxoSmithKline's SSRI Paxil or its generic form were at least twice as likely to have obstructions in the right ventricle of the heart, the Journal reports. According to the Journal, obstructions in the right ventricle are rare, even in infants exposed to the drug, and Paxil carries a warning that it could cause heart defects in fetuses (Wall Street Journal, 6/28). In addition, there appeared to be an increased risk for birth defects among infants born to obese women who took SSRIs, Sonja Rasmussen of CDC said (Gellene, Los Angeles Times, 6/28).
Reaction
According to researchers, women should talk to their doctors about weighing the risks of birth defects with the benefit of SSRIs before deciding whether to stop treatment (Bloomberg/Baltimore Sun, 6/28). Jennita Reefhuis, a CDC epidemiologist, cautioned pregnant women against stopping their SSRIs without first talking with their doctor (USA Today, 6/28). Carol Louik, a professor at Boston University and a lead author of one of the studies, said, "It's important to keep in perspective that the absolute risks are relatively small." Margaret Spinelli, an assistant professor at the Columbia University College of Physicians and Surgeons, said that if the risk of SSRIs is "relatively safer than the illness itself, [women] are more likely to choose the medication" (Bloomberg/Baltimore Sun, 6/28).
Michael Greene, an obstetrician at Harvard Medical School, in an accompanying NEJM editorial wrote that although women and doctors "would prefer it if there were clear lines separating 'risk' and 'no risk'" with SSRIs, the increased risk of birth defects likely will affect few infants (USA Today, 6/28).
The CDC study is available online. The Slone study also is available online.
CBS' "Evening News" on Wednesday reported on the studies. The segment includes comments from Louik, Rebecca Brightman of Mount Sinai Medical Center and a patient (Miller, "Evening News," CBS, 6/27). Video of the segment and expanded CBS News coverage are available online.
NBC's "Nightly News" on Wednesday also reported on the studies. The segment includes comments from Stephan Quentzel of Beth Israel Medical Center in New York City, Reefhuis and a patient (Snyderman, "Nightly News," NBC, 6/27). Video of the segment is available online.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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