January 22, 1997
Common antidepressant drugs safe in pregnancy; infant neurodevelopment not affected
TORONTO - Women who require antidepressant medication while pregnant, but are worried about the risk to their unborn babies, may be relieved at the results of a study to be published in the January 23 issue of the New England Journal of Medicine.
It is the first study which demonstrates that the drugs which are most commonly prescribed for depression - tricyclic antidepressants and fluoxetine (Prozac) - are safe to use during pregnancy. The study was led by researchers at The Hospital for Sick Children (SickKids) and the University of Toronto, and includes collaborators at The Toronto Hospital and Oshawa General Hospital.
"These results are important for pregnant women or women planning pregnancies who require drug treatment for depression," explains Dr. Gideon Koren, head of SickKids division of Clinical Pharmacology and Toxicology and Motherisk program, and a Professor of Paediatrics, Pharmacology, and Medicine at the U of T. "Until now, physicians have not had the information they need to reassure women that exposure to these drugs during the first trimester or continuous use during pregnancy is safe. As a result, women very often discontinued needed drug treatment, risking severe illness or even suicide attempts."
Previous studies had not taken into consideration such factors as coexisting diseases or maternal lifestyle (e.g. cigarette and alcohol use) which may affect the outcome of the pregnancy. As a result, the information concerning the impact of these drugs on the fetus was unreliable.
An estimated eight to 20 percent of women have depression at some time in their lives, most commonly during childbearing years, and often requiring drug therapy. Many of these women will require antidepressants during pregnancy.
The study involved 219 children: 80 children of mothers who received a tricyclic anti-depressant drug during pregnancy; 55 children whose mothers received fluoxetine; and a control group of 84 children whose mothers had not been exposed in pregnancy to any drug or chemical known to cause physical abnormalities in the fetus.
"This study was designed to assess the cognitive and language development and behaviour of children up to age four exposed in utero to these drugs," explains SickKids psychologist Joanne Rovet, who conducted the neurobehavioural component of the study. "We found that there was no difference between the children who were exposed to the drugs and those who weren't."
The study was conducted through The Hospital for Sick Children's Motherisk program, a multi-disciplinary information and consultation service for women, their families, and health professionals regarding exposure during pregnancy and breast feeding to drugs, chemicals, radiation, and infectious agents.
Funding for the study was provided by the Motherisk Research Fund, Ciba Geigy Canada, The Medical Research Council of Canada, and the Pharmaceutical Manufacturers Association of Canada.
The Hospital for Sick Children is a health care, teaching and research centre dedicated exclusively to children; affiliated with the University of Toronto.
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