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
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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