SSRI's found
to adversely affect newborns during first days of life
Sat, 26 Jul 2003
Doctors prescribing antidepressant drugs (SSRIs) to
pregnant women may be faced with liability claims, as these
drugs are shown to adversely affect unborn and newborn babies'
central nervous system
A new report in the Archives of General Psychiatry found:
"We report increased risk for central nervous system
serotonergic adverse effects during the first days of life in
newborns of mothers taking the SSRIs citalopram or fluoxetine
during the third trimester of pregnancy," they write. "The
clinical relevance of the present results is awareness of the
psychiatrists who prescribe SSRIs during pregnancy and the
pediatricians who treat the serotonin-related neurologic
symptoms of the newborns during the first days of life.
Although these effects seem to subside quickly, they may
expose the infants to more serious neonatal complications such
as convulsions."
The question is: How long before the FDA calls for a
warning on these drugs' label?
http://www.medscape.com/viewarticle/458559
MEDSCAPE
Use of SSRIs During Pregnancy May Cause Neurologic Symptoms in
Newborns
Laurie Barclay, MD
July 14, 2003 Newborns of mothers receiving fluoxetine or
citalopram exhibited symptoms of central serotonin
overstimulation for about four days, according to the results
of a prospective trial published in the July issue of the
Archives of General Psychiatry. The investigators warn of
potential neurologic adverse effects from selective serotonin
reuptake inhibitors (SSRIs) used during late pregnancy.
"SSRIs have gained wide acceptance in the treatment of
mental disorders in pregnant women, but there seems to be an
increased risk for neonatal adaptation problems after exposure
to SSRIs in late pregnancy," write Kari Laine, MD, PhD, from
the University of Turku in Finland, and colleagues. They cite
previous studies suggesting that exposure to SSRIs during the
third trimester may cause irritability, constant crying,
eating and sleeping difficulties, and even seizures in
newborns.
Between January 1, 1997, and August 31, 2000, Dr. Laine's
group enrolled 40 pregnant women, including 20 who were taking
SSRIs during pregnancy and breast-feeding and 20 who were not
taking any psychoactive medications. All infants had
neurologic assessments during the first four days of life and
at two weeks and two months of age after delivery, as well as
brain ultrasound and magnetic resonance imaging (MRI) 38 to 42
weeks after conception and at two months of age. During the
first two months of life, blood pressure, heart rate, and body
temperature were similar in both groups. During the first four
days of life, the serotonergic symptom score reflecting
tremor, restlessness, and rigidity was four times higher in
the SSRI group than in the control group (P = .008).
Serotonin-related symptoms declined significantly in the SSRI
group from the first four days to two weeks, and there was no
significant difference in serotonergic symptom score between
the two groups at two weeks.
Cord blood concentration of 5-hydroxyindoleacetic acid
(5-HIAA) was significantly lower in the SSRI group than in the
control group (P = .02). Umbilical vein 5-HIAA concentration
was inversely correlated with serotonergic symptom score in
the SSRI group (r = -0.66; P = .007) but not in the control
group.
Because the symptoms resolved quickly while SSRI
concentrations were decreasing, the authors suggest that the
symptoms are related to central nervous system serotonergic
overstimulation rather than to SSRI withdrawal syndrome.
"We report increased risk for central nervous system
serotonergic adverse effects during the first days of life in
newborns of mothers taking the SSRIs citalopram or fluoxetine
during the third trimester of pregnancy," they write. "The
clinical relevance of the present results is awareness of the
psychiatrists who prescribe SSRIs during pregnancy and the
pediatricians who treat the serotonin-related neurologic
symptoms of the newborns during the first days of life.
Although these effects seem to subside quickly, they may
expose the infants to more serious neonatal complications such
as convulsions."
The Turku University Hospital Research Fund supported this
study. Arch Gen Psychiatry. 2003;60:720-726 Reviewed by Gary
D. Vogin, MD
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