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5/7/2017
Topic:
Antidepressants in pregnancy
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Notes: Results include: Last 5 years, main focus of article.
1: BJOG. 2008 Jan;115(2):283-9. Epub 2007 Sep 27.
Neonatal outcome following pregnancy exposure to antidepressants: a prospective
controlled cohort study.
Maschi S, Clavenna A, Campi R, Schiavetti B, Bernat M, Bonati M.
Laboratory for Mother and Child Health, "Mario Negri" Pharmacological Research
Institute, Milan, Italy.
OBJECTIVE: To determine the incidence of early adverse effects associated with
antidepressant drug use during pregnancy. DESIGN: Prospective, controlled cohort
study. SETTING: A Drug and Health Information Centre in Milan, Italy. POPULATION:
A total of 200 neonates exposed to antidepressants in utero and 1200 controls.
METHODS: Women who took antidepressants during pregnancy and delivered liveborn
children between 1995 and 2003 were selected. Each case was matched for maternal
age and gravidity to six randomly selected controls (not exposed to teratogenic
drugs or drugs known to cause neonatal side effects). Odds ratio was estimated
for attributable risks. MAIN OUTCOME MEASURES: Neonatal adverse events and
Special Care Unit admission rate, assessed through an interview with the mothers.
RESULTS: Of the 200 neonates exposed to antidepressants in utero, 14 had adverse
events and 3 required Special Care Unit admission. Jaundice (n = 5), agitation (n
= 3) and respiratory distress (n = 2) were the most common symptoms. In the
control group, 50 newborns had side effects and no statistically significant
differences in the prevalence rate compared to the exposed group were found, even
after stratification for drugs and pregnancy period of exposure. Only the
prematurity rate was significantly higher in exposed compared to non-exposed
newborns (OR = 2.31; 95% CI 1.14-4.63). CONCLUSIONS: These results do not support
an association between antidepressant exposure and unsafe fetal and neonatal
outcomes in newborns. However, a collaborative international multicentre
epidemiological monitoring of the use of psychotropic drugs during pregnancy is
needed in order to guarantee pregnant women and their children safe and effective
treatments, both at brief and long time from exposure.
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PMID: 17903222 [PubMed - indexed for MEDLINE]
2: Am J Psychiatry. 2007 Aug;164(8):1206-13.
Effects of antenatal depression and antidepressant treatment on gestational age
at birth and risk of preterm birth.
Suri R, Altshuler L, Hellemann G, Burt VK, Aquino A, Mintz J.
Mood Disorders Research Program, Department of Psychiatry, Semel Institute for
Neuroscience and Human Behavior, University of California, Los Angeles, CA 90095,
USA. [email protected]
OBJECTIVE: The authors evaluated the effects of prenatal antidepressant exposure
and maternal depression on infant gestational age at birth and risk of preterm
birth. METHOD: Ninety women were followed in a prospective, naturalistic design
through pregnancy with monthly assessments of symptoms of depression and anxiety
using the Structured Clinical Interview for DSM-IV mood module for depression,
the Hamilton Depression Rating Scale, the Beck Depression Inventory, and the
Perceived Stress Scale. Participants included 49 women with major depressive
disorder who were treated with antidepressants during pregnancy (group 1), 22
women with major depressive disorder who were either not treated with
antidepressants or had limited exposure to them during pregnancy (group 2), and
19 healthy comparison subjects (group 3). The primary outcome variables were the
infants' gestational age at birth, birth weight, 1- and 5-minute Apgar scores,
and admission to the special care nursery. RESULTS: Groups 1, 2, and 3 differed
significantly in gestational age at birth (38.5 weeks, 39.4 weeks, 39.7 weeks,
respectively), rates of preterm birth (14.3%, 0%, 5.3%, respectively), and rates
of admission to the special care nursery (21%, 9%, 0%, respectively). Birth
weight and Apgar scores did not differ significantly between groups. Mild to
moderate depression during pregnancy did not affect outcome measures.
CONCLUSIONS: Prenatal antidepressant use was associated with lower gestational
age at birth and an increased risk of preterm birth. Presence of depressive
symptoms was not associated with this risk. These results suggest that medication
status, rather than depression, is a predictor of gestational age at birth.
Publication Types: Clinical Trial Comparative Study Research Support, N.I.H., Extramural
PMID: 17671283 [PubMed - indexed for MEDLINE]
3: J Clin Psychiatry. 2007 Aug;68(8):1284-9.
Comment in: J Clin Psychiatry. 2007 Aug;68(8):1277-8.
Birth outcomes following prenatal exposure to antidepressants.
Pearson KH, Nonacs RM, Viguera AC, Heller VL, Petrillo LF, Brandes M, Hennen J,
Cohen LS.
Perinatal and Reproductive Psychiatry Program, Massachusetts General Hospital,
Boston, MA 02114, USA. [email protected]
BACKGROUND: Antidepressant use during pregnancy and the peripartum period is
common despite the absence of clear evidence-based guidelines to direct clinical
use of these compounds. METHOD: We compared obstetrical and neonatal outcomes as
recorded in medical records among 84 pregnant women with major depressive or
anxiety disorders (DSM-IV criteria) who took antidepressants during pregnancy
(cases) versus a 2:1 age- and parity-matched control group of 168 unexposed
women. Women in the case group had sought psychiatric consultation regarding the
use of medication from the Perinatal and Reproductive Psychiatry Program at the
Massachusetts General Hospital between 1996 and 2000. RESULTS: There were no
significant differences among cases versus controls and their offspring, with
respect to various neonatal and obstetrical outcomes, including gestational age
and weight, although 1-minute Apgar scores were slightly lower in exposed
infants. Admissions to the special care nursery were more frequent, but briefer
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and based on relatively minor indications, among case newborns. There were no
significant differences in neonatal outcomes between exposures to serotonin
reuptake inhibitor (SRI) and tricyclic (TCA) antidepressants. CONCLUSION: This
retrospective cohort study found no evidence of major increases in risk of
adverse obstetrical or neonatal outcomes following prenatal exposure to
antidepressants, nor between SRIs and TCAs. Larger, prospective studies with
specific neurobehavioral measures are required to resolve current uncertainties
about safe and effective use of antidepressants by pregnant women.
PMID: 17854255 [PubMed - indexed for MEDLINE]
4: Cleve Clin J Med. 2006 Dec;73(12):1098-104.
Treating depression in pregnancy: practical suggestions.
Gonsalves L, Schuermeyer I.
Department of Psychiatry and Psychology, Gault Women's Health and Breast
Pavilion, Cleveland Clinic Foundation, OH 44195, USA.
Failure to treat depression during pregnancy can lead to problems for the mother
and the baby. However, given the lack of convincing evidence of the safety of
antidepressant drugs to the fetus during pregnancy and lactation, any
antidepressive treatment plan must be embarked on with caution. The authors offer
practical guidelines for managing depression during pregnancy and lactation.
Publication Types: Review
PMID: 17190314 [PubMed - indexed for MEDLINE]
5: J Clin Psychiatry. 2006 Aug;67(8):1280-4.
Exposure to mirtazapine during pregnancy: a prospective, comparative study of
birth outcomes.
Djulus J, Koren G, Einarson TR, Wilton L, Shakir S, Diav-Citrin O, Kennedy D,
Voyer Lavigne S, De Santis M, Einarson A.
Motherisk Program, Division of Clinical Pharmacology, the Hospital for Sick
Children, Toronto, Ontario, Canada.
BACKGROUND: Mirtazapine is a novel piperazinoazepine antidepressant, unrelated to
any known class of antidepressants. Currently, apart from a few case reports and
case series in the literature, there are no studies evaluating the safety of this
drug during pregnancy. OBJECTIVE: To determine whether mirtazapine increases the
risk for major malformations in newborns when used by pregnant women. METHOD: The
study design was prospective, with 2 comparison groups: disease-matched pregnant
women diagnosed with depression taking other antidepressants and pregnant women
exposed to nonteratogens. The primary outcome was major malformations in
neonates; secondary endpoints included spontaneous abortions, therapeutic
abortions, gestational age at birth, and mean birth weight. Women were recruited
from 5 teratogen information services in Toronto, Canada; Farmington, Conn.,
U.S.A.; Jerusalem, Israel; Rome, Italy; Sydney, Australia; and from the Drug
Safety Research Unit in Southampton, United Kingdom. Women were recruited into
the study from June 2002 to August 2005. RESULTS: We were able to follow 104
pregnancy outcomes in each drug group. There were 77 live births, 1 stillbirth,
20 spontaneous abortions, 6 therapeutic abortions, and 2 major malformations in
the mirtazapine group. The mean SD birth weight was 3335 654 g and the
mean SD gestational age at delivery was 38.9 2.5 weeks. Most (95%) of the
women took mirtazapine in the first trimester, but only 25% of the women took it
throughout pregnancy. The differences among the 3 groups were in the rate of
spontaneous abortions, which was higher in both antidepressant groups (19% in the
mirtazapine group and 17% in the other antidepressant group) than in the
nonteratogen group (11%), but none of the differences were statistically
significant. The rate of preterm births (prior to 37 weeks' gestation) was also
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higher in the mirtazapine group (10%) and in the other antidepressant group (7%)
than in the nonteratogen group (2%). The difference was statistically significant
between the mirtazapine group and the nonteratogen group (p = .04). CONCLUSION:
Mirtazapine does not appear to increase the baseline rate of major malformations
of 1% to 3%. However, the higher number of spontaneous abortions in the
antidepressant groups confirms the higher rates of spontaneous abortions in
pregnant women taking antidepressant medications found in previous studies.
Publication Types: Comparative Study Multicenter Study Research Support, Non-U.S. Gov't
PMID: 16965209 [PubMed - indexed for MEDLINE]
6: J Psychiatry Neurosci. 2006 Jul;31(4):226-8.
Comment in: J Psychiatry Neurosci. 2006 Nov;31(6):411; author reply 411-2.
Pregnancy, depression, antidepressants and breast-feeding.
Blier P.
Publication Types: Editorial
PMID: 16862240 [PubMed - indexed for MEDLINE]
7: Br J Clin Pharmacol. 2006 Feb;61(2):155-63.
Stereoselective disposition of fluoxetine and norfluoxetine during pregnancy and
breast-feeding.
Kim J, Riggs KW, Misri S, Kent N, Oberlander TF, Grunau RE, Fitzgerald C, Rurak
DW.
Department of Psychiatry, University of British Columbia.
AIMS: To compare the disposition of fluoxetine and norfluoxetine enantiomers in
the mother, foetus and infant. METHODS: Blood from pregnant women taking
fluoxetine (n = 9), during pregnancy was sampled in the third trimester and at
delivery (maternal and cord venous blood), and from the infants 48 h after
delivery. The subset of these women who were breastfeeding, plus additional
subjects recruited in the postpartum period, were studied further, and maternal
and infant blood, and breast milk was sampled between 6 days and 11 months (n =
23). Drug and metabolite concentrations were measured using gas
chromatography/mass spectrometry or liquid chromatography, tandem mass
spectrometry. RESULTS: There was a high correlation between maternal and foetal
(cord blood) fluoxetine and norfluoxetine enantiomers (r(2)-0.9), the mean
foetal/maternal ratios (95% confidence intervals) being 0.91 (0.61, 1.02) and
1.04 (0.93, 1.05), for fluoxetine and norfluoxetine, respectively. In 2 day old
infants exposed to the drug in utero, the fluoxetine and norfluoxetine plasma
concentrations were the same as in cord blood at delivery. Over the next 2
months, the plasma concentrations in the infants fell progressively.
Stereoselective disposition of both the drug and metabolite in the mother,
foetus, infant and breast milk was observed. The S : R ratios in the foetus and
newborn ( approximately 3) were significantly higher than in the serum (
approximately 2) or breast milk ( approximately 1.9) of the mothers, resulting in
greater exposure of the foetus and infants to the biologically active
enantiomers, particularly S-norfluoxetine. CONCLUSIONS: Foetal and infant
exposure to fluoxetine and norfluoxetine is enhanced by their stereoselective
disposition in the mother, foetus, breast milk and infant. Increased exposure may
also result from decreased metabolism of the drug in the foetus and neonate.
Publication Types: Multicenter Study Research Support, Non-U.S. Gov't
PMID: 16433870 [PubMed - indexed for MEDLINE]
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8: Am J Obstet Gynecol. 2005 Dec;193(6):2004-9.
Citalopram use in pregnancy: prospective comparative evaluation of pregnancy and
fetal outcome.
Sivojelezova A, Shuhaiber S, Sarkissian L, Einarson A, Koren G.
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, The
Hospital for Sick Children, Ontario, Canada. [email protected]
OBJECTIVE: Citalopram is a selective serotonin reuptake inhibitor indicated for
depression. The safety of this medication in pregnancy has not been fully
established. The purpose of this study was to investigate whether citalopram is
associated with an increased incidence of adverse pregnancy outcomes. STUDY
DESIGN: Pregnant women who contacted the Motherisk Program, a Teratogen
Information Center in Toronto, Ontario, with regard to the safety of citalopram
in pregnancy were enrolled in the study. The exposed women were matched to a
disease-matched group of women and a nonteratogenic group. All women were matched
for age ( 2 years) and gestational age at time of first call to the Motherisk
( 2 weeks). A structured telephone follow-up interview was conducted following
the expected date of confinement. RESULTS: The total number of pregnant women
enrolled in this study was 396 (132 women in each group). A total of 125 women
took citalopram at least in the first trimester. Seventy-one (54%) women
continued to take the drug throughout pregnancy. One hundred fourteen women (86%)
had live births, 14 (11%) had spontaneous abortions, 2 (1.5%) had elective
terminations, and 2 (1.5%) experienced stillbirths. Fetal survival rates, mean
birth weights, and duration of pregnancy were not statistically different among
the 3 groups. Of 108 live-born infants whose mothers were exposed to citalopram
in the first trimester, there was 1 (0.9%) male infant born with a major
malformation. There was a relative risk of 4.2 (95% confidence interval
1.71-10.26) in neonates exposed to citalopram close to term to be admitted to
special-care nurseries as compared with the unexposed infants. CONCLUSION:
Citalopram use during the period of embryogenesis in pregnancy is not associated
with an apparent major teratogenic risk. Late pregnancy use of citalopram is
associated with increased risk of poor neonatal adaptation syndrome, recently
described with other selective serotonin reuptake inhibitors.
Publication Types: Comparative Study Research Support, Non-U.S. Gov't
PMID: 16325604 [PubMed - indexed for MEDLINE]
9: J Psychiatr Pract. 2005 Nov;11(6):389-96.
Depression in pregnancy and the postpartum period: balancing adverse effects of
untreated illness with treatment risks.
Mian AI.
University of Texas, Houston, TX, USA.
The author reviews the risks and benefits of untreated maternal depression during
pregnancy and the postnatal period and its effects on the well-being of the
mother and infant. She then discusses the significant role psychiatrists can play
in detecting and managing maternal depression as a primary measure for preventing
future child psychopathology. A literature search was conducted on PubMed to
identify both preclinical and clinical studies concerning deleterious effects of
maternal depression on offspring. Additional searches focused on available safety
data concerning the use of antidepressants during pregnancy and lactation. Key
search items included depression during pregnancy, postpartum depression,
lactation, and antidepressants. Burgeoning evidence was found concerning the
adverse effects of maternal depression on the developing fetus and infant in the
perinatal period. No controlled studies on the safety of antidepressant use in
pregnancy and lactation were found; therefore, case reports, and some
retrospective and prospective case series, must serve as guidelines for the
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treating clinician. Each case of maternal depression needs to be evaluated on an
individual basis and decisions about treatment interventions should involve both
the patient and family. Maternal depression during pregnancy and the postnatal
period is associated with a significant disease burden in that it affects not
only the mother but may also have both short- and long-term effects on offspring.
Therefore, early detection and management of maternal depression, of which
perinatal screening of mothers is an important component, are warranted.
Publication Types: Review
PMID: 16304507 [PubMed - indexed for MEDLINE]
10: Am J Obstet Gynecol. 2005 Mar;192(3):932-6.
Pregnancy outcome of women exposed to bupropion during pregnancy: a prospective
comparative study.
Chun-Fai-Chan B, Koren G, Fayez I, Kalra S, Voyer-Lavigne S, Boshier A, Shakir S,
Einarson A.
The Motherisk Program, The Hospital for Sick Children, Toronto, Ontario, Canada.
OBJECTIVE: Bupropion was developed for the treatment of depression, but
subsequently was found to be effective for smoking cessation. To date, there are
no prospective comparative studies examining its safety in pregnancy. The primary
objective was to determine whether bupropion increases the risks for major
malformations above baseline. The secondary objective was to examine the rates of
live births, stillbirths, spontaneous and therapeutic abortions, mean birth
weight, and gestational age at birth. STUDY DESIGN: Women who were pregnant or
planning a pregnancy and taking bupropion were enrolled in the study. Follow-up
of pregnancy outcome was carried out between 4 months and 1 year after delivery.
Three comparisons were carried out: 1) women exposed to bupropion vs a
nonteratogen group; 2) those taking for depression vs other antidepressants, vs a
nonteratogen group; 3) spontaneous abortions were compared between those taking
for depression, vs another antidepressant group vs a nonteratogen group. RESULTS:
We completed follow-up on 136 women exposed to bupropion during the first
trimester of pregnancy. There were (105) live births, no major malformations, the
mean birth weight was (3450g), the mean gestational age at delivery was (40
weeks), the number of spontaneous abortions was 20, there were 10 therapeutic
abortions, there was 1 stillbirth, and 1 neonatal death. There were no
statistically significant differences between any of the end points we examined
between the exposed and comparison groups, with the exception of significantly
more spontaneous abortions in the bupropion group (P = .009). CONCLUSION: These
results suggest that bupropion does not increase the rates of major malformation
above baseline. The higher rates of spontaneous abortions are similar to other
studies examining the safety of antidepressants during pregnancy.
Publication Types: Comparative Study
PMID: 15746694 [PubMed - indexed for MEDLINE]
11: Am J Psychiatry. 2003 May;160(5):993-6.
Placental passage of antidepressant medications.
Hendrick V, Stowe ZN, Altshuler LL, Hwang S, Lee E, Haynes D.
Mood Disorders Research Program, UCLA Neuropsychiatric Institute and Hospital,
University of California-Los Angeles, 300 Medical Plaza, Suite 2345, Los Angeles,
CA 90095, USA. [email protected]
OBJECTIVE: This study determined the placental transfer of antidepressants and
their metabolites. METHOD: A total of 38 pregnant women taking citalopram,
fluoxetine, paroxetine, or sertraline participated. Maternal and umbilical cord
blood samples were obtained to determine antidepressant and metabolite
concentrations. RESULTS: Antidepressant and metabolite concentrations were
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detectable in 86.8% of umbilical cord samples. The mean ratios of umbilical cord
to maternal serum concentrations ranged from 0.29 to 0.89. The lowest ratios were
for sertraline and paroxetine; the highest were for citalopram and fluoxetine.
Maternal doses of sertraline and fluoxetine correlated with umbilical cord
concentrations of these medications. CONCLUSIONS: Umbilical cord concentrations
of antidepressants and their metabolites were almost invariably lower than
corresponding maternal concentrations. Maternal doses predicted umbilical
concentrations of fluoxetine and sertraline. Mean umbilical cord to maternal
serum ratios were significantly lower for sertraline than fluoxetine, suggesting
that sertraline may produce less fetal medication exposure than fluoxetine near
delivery.
Publication Types: Research Support, U.S. Gov't, P.H.S.
PMID: 12727706 [PubMed - indexed for MEDLINE]
12: J Clin Psychiatry. 2003 Apr;64(4):410-2.
Weight gain in breastfed infants of mothers taking antidepressant medications.
Hendrick V, Smith LM, Hwang S, Altshuler LL, Haynes D.
Department of Psychiatry and Behavioral Sciences, UCLA Neuropsychiatric Institute
and Hospital, Los Angeles, CA 90095, USA. [email protected]
BACKGROUND: Little is known about the physical development of infants who are
exposed to antidepressant medications through breast milk. METHOD: Seventy-eight
breastfeeding women taking antidepressant medications were included in the study.
Maternal mood was prospectively evaluated at 6, 12, and 18 months postpartum.
Infants' weights were obtained from review of pediatric records. Data were
gathered from 1997 to 2002. RESULTS: Infants' weights were not significantly
different from weights of 6-month-old breastfed infants from normative
populations. However, infants of mothers who relapsed to relatively long-lasting
major depressive episodes (lasting 2 months or more) following delivery weighed
significantly (p =.002) less when compared with infants of mothers who relapsed
to brief depressive episodes (< 2 months) and infants of mothers who did not
relapse to depression in the postpartum period. This finding remained after
including medication dosage and infant birth weight as covariates. CONCLUSION:
Exposure to antidepressant medications through breast milk does not appear to
affect infants' weight. However, infants exposed to maternal depression lasting 2
months or more appear to experience significantly lower weight gain than infants
of euthymic mothers or mothers who experience brief (< 2 months) major depressive
episodes. Maternal depression following delivery may influence behaviors that,
over the course of 2 months or more, affect infants' weight gain.
Publication Types: Comparative Study Research Support, U.S. Gov't, P.H.S.
PMID: 12716242 [PubMed - indexed for MEDLINE]
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