Note: the following is a press release from Eli Lilly and Company (although the research was done elsewhere). As such it is only representing Eli Lilly's viewpoint. - Brian.

Experts laud first data analyzing SSRI impact on neurodevelopment

INDIANAPOLIS----Jan. 22, 1997--
The first study that examines IQ, language and behavior development in children of mothers who used Prozac(R) (fluoxetine hydrochloride) during pregnancy is being viewed by mental health experts as important data for women of child-bearing years who suffer from clinical depression.
The study, authored by a group led by Gideon Koren, M.D., head of clinical pharmacology and toxicology at The Hospital for Sick Children in Toronto, appears Jan. 23 in The New England Journal of Medicine. Dr. Koren's data shows that preschool children of mothers who took Prozac demonstrated similar neurodevelopmental skills as children whose mothers used older tricyclic antidepressants (TCAs) or no antidepressant.
The NEJM article is the first published data regarding the impact on neurobehavior by any selective serotonin reuptake inhibitor (SSRI), a newer class of antidepressants. ``We now have important information to consider in the risk/benefit analysis of antidepressant use in clinically depressed expectant mothers,'' said Donna E. Stewart, M.D., Chair of Women's Health at The Toronto Hospital and an investigator for the study. ``Dr. Koren's group should be applauded for tackling this important - and, until now, untapped - issue,'' said Lee S. Cohen, M.D., a psychiatrist at Massachusetts General Hospital and associate professor of psychiatry at Harvard University. ``The safety of all medications remains among the chief concerns for women who are pregnant or who are thinking about becoming pregnant. The information supplied by Dr. Koren regarding fluoxetine and TCAs will help treatment planning for women during child-bearing years who suffer from depression.''
An estimated one in four women will suffer from depression in their lifetime. Women are twice as likely as men to suffer from clinical depression. Independent studies have linked ramifications of untreated depression during pregnancy with fetal anomalies. ``Because half of the pregnancies in North America are unplanned,'' Dr. Koren wrote, ``many women are eventually using TCA and fluoxetine during the first few months of their pregnancy. ``Many women who suffer from depression need drug therapy to secure their well-being during pregnancy,'' added Dr. Koren, who heads the Motherisk Program at the hospital and is a professor of pediatrics, pharmacology and medicine at the University of Toronto. ``If they are not treated for depression, their well-being and life may be endangered. Women with depression often commit suicide, so this is a serious illness. Their lives are threatened.''
More published information regarding usage during child-bearing years is available on Prozac, manufactured by Indianapolis-based Eli Lilly and Company, than any other antidepressant. Dr. Koren's study was funded by the Medical Research Council of Canada. Prozac, which this year will mark the 10th anniversary of its clearance by the Food and Drug Administration, was the first antidepressant in the SSRI class to be introduced in the United States.
Prozac remains one of the most-studied medications in the world. Prozac should be taken during pregnancy only if clearly needed and when prescribed by a physician. Prozac should not be started or stopped without consulting a physician. Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., dedicated to creating and delivering innovative pharmaceutical-based health care solutions that enable people to live longer, healthier and more active lives. Complete prescribing information for Prozac(R) (fluoxetine hydrochloride) is available upon request from Eli Lilly and Company or at no charge.
. To obtain a copy, simply call 888/286-8107 toll free and reference document no. 4210. --30--jil/clv*

CONTACT: Eli Lilly and Company, Indianapolis Greg Kueterman, 317/277-6738

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