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February 25, 1998

"New generation" of antidepressants found safe in pregnancy

TORONTO - The first study of antidepressants dubbed the "next generation after Prozac" has shown that they are safe to take during pregnancy and do not increase the risk of birth defects, miscarriage, stillbirth or prematurity. The study assessed the effects of three new selective serotonin reuptake inhibitors (SSRI), a class of anti-depressant used by millions of people worldwide. The report is published in the February 25 issue of the Journal of the American Medical Association.

"This study is important because more than half of all pregnancies are unplanned and women of childbearing age are those most likely to be taking antidepressants," explains study director Dr. Gideon Koren, head of the Motherisk program at The Hospital for Sick Children and professor of Paediatrics at the University of Toronto. "Until now, no information existed about the possible effects of the new SSRIs on an unborn baby. This study looked at the effects of the SSRIs fluvoxamine, paroxetine and sertraline."

The study included 534 patients from nine Teratology Information Service centres in the United States and Canada, including the Motherisk program at The Hospital for Sick Children. Half of the patients had been exposed to one of the new SSRIs in the first trimester of pregnancy and contacted a Teratology Information Service regarding their exposure. The patients in the control group were women who had contacted the Motherisk program about exposure to agents known to be safe in pregnancy.

"The results show that there is no difference in pregnancy outcome between the women who were exposed to a new SSRI and those who weren't," explains Dr. Koren. "The result is the same even for women who took an SSRI throughout their entire pregnancy. This is especially good news for women who require antidepressant medication and are planning a pregnancy."

When the women in the study first contacted a Teratology Information Service they were asked about a variety of health-related issues, including diagnosis, SSRI dose schedule and length of treatment, cigarette and alcohol consumption, and past medical, obstetric and genetic history. They were then contacted approximately six to nine months after the expected delivery date and asked about the course of the pregnancy, pregnancy outcome, and neonatal health.

The Motherisk program, established by The Hospital for Sick Children in 1985, offers in-person and telephone information and consultations regarding the effects of drugs and chemicals on the developing fetus or during breast feeding. Motherisk logs more than 25,000 calls per year.

Other researchers involved in the study include former University of Toronto graduate student Nathalie Kulin and Anne Pastuszak, director of the Fetal Diagnosis and Treatment Centre at The Hospital for Sick Children.

Funding for this study was provided by the Motherisk Research Fund.

For more information, please contact:

Public Affairs
The Hospital for Sick Children
555 University Avenue
Suite 1742, Public Affairs, First floor Atrium
Toronto, ON
M5G 1X8
Canada
Phone: 416-813-5058
Fax: 416-813-5328