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O'Connor E, Rossom RC, Henninger M, et al. Screening for Depression in Adults: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Jan. (Evidence Syntheses, No. 128.)

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Screening for Depression in Adults: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet].

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Appendix AFDA Antidepressant Drug Labels for Pregnant and Postpartum Women

On October 7, 2014, we searched for the current drug label information of brand name antidepressants on the Drugs@FDA website (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/). We also examined drug approval and labeling revision documents for any medical or statistical reviews associated with labeling considerations for pregnant or postpartum women. Discontinued drugs were not evaluated.

Generic
(Brand Name)
FDA Pregnancy Category*Drug Label: Fetal/Neonate ComplicationsDrug Label: Nursing ConsiderationsOther Nursing Considerations82
SSRIs
Sertraline
(Zoloft)
CNonteratogenic effects include complications requiring prolonged hospitalization, respiratory support, and tube feeding upon delivery. Other clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; infants exposed to SSRIs in pregnancy may have an increased risk PPHN and is associated with substantial neonatal morbidity and mortality. Several recent studies suggest a positive statistical association between SSRI use in pregnancy and PPHNIt is not known whether, and in what amount, sertraline or its metabolites are excreted in human milk. Caution should be exercised when administered to nursing womenStudies generally confirm that the transfer of sertraline and its metabolite to the infant is minimal and attaining clinically relevant plasma levels in infants is remote
Paroxetine
(Pereva, Paxil)
DEpidemiological studies have shown that infants exposed to paroxetine in the first trimester have an increased risk of congenital malformations, particularly cardiovascular malformations; nonteratogenic effects include complications requiring prolonged hospitalization, respiratory support, and tube feeding upon delivery. Other clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; infants exposed to SSRIs in pregnancy may have an increased risk for PPHN and is associated with substantial neonatal morbidity and mortality. Several recent studies suggest a positive statistical association between SSRI use in pregnancy and PPHNParoxetine is secreted in human milk and caution should be exercised when administering to nursing womenStudies suggest minimal to no effect on breastfed infants. Most studies show minimal to no plasma levels in breastfed infants
Fluvoxamine
(Luvox)
CIncreased embryofetal death, increased incidences of fetal eye abnormalities, decreased fetal body weight; nonteratogenic effects include complications requiring prolonged hospitalization, respiratory support, and tube feeding upon delivery. Other clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; infants exposed to SSRIs in pregnancy may have an increased risk for PPHN and is associated with substantial neonatal morbidity and mortality. Several recent studies suggest a positive statistical association between SSRI use in pregnancy and PPHNFluvoxamine is secreted in human breast milk, potential for serious adverse effects from exposure in the nursing infant should be taken into consideration when the decision to continue or discontinue use is madeData from studies suggests only minuscule amounts of fluvoxamine are transferred to infants, plasma levels in infants are too low to be detected, and no adverse effects have been noted
Fluoxetine
(Prozac)
CFetal cardiovascular malformations; nonteratogenic effects include complications requiring prolonged hospitalization, respiratory support, and tube feeding upon delivery. Other clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; infants exposed to SSRIs in pregnancy may have an increased risk for PPHN and is associated with substantial neonatal morbidity and mortality. Several recent studies suggest a positive statistical association between SSRI use in pregnancy and PPHNBecause Prozac is excreted in human milk, nursing while on Prozac is not recommended. Studies show mixed results in nursing infants; some show no adverse effects and others reporting increased crying, sleep disturbance, vomiting, and watery stools in exposed infants.Women taking fluoxetine should be advised to continue breastfeeding and observe the infant for side effects. Severe colic, fussiness, and crying have been reported.
Escitalopram
(Lexapro)
CNonteratogenic effects include complications requiring prolonged hospitalization, respiratory support, and tube feeding upon delivery. Other clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; infants exposed to SSRIs in pregnancy may have an increased risk for PPHN and is associated with substantial neonatal morbidity and mortality. Several recent studies suggest a positive statistical association between SSRI use in pregnancy and PPHNEscitalopram is excreted in human breast milk, so caution should be exercised and breastfeeding infants should be observed for adverse reactions when administering to nursing women. Some reports of infants experiencing excessive somnolence, decreased feedings, and weight lossRecent data concerning use in breastfeeding mothers suggests the relative infant dose is low and plasma levels in breastfed infants are largely undetectable. No adverse events in infants were reported
Citalopram
(Celexa)
CNonteratogenic effects include complications requiring prolonged hospitalization, respiratory support, and tube feeding upon delivery. Other clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying; infants exposed to SSRIs in pregnancy may have an increased risk for PPHN and is associated with substantial neonatal morbidity and mortality. Several recent studies suggest a positive statistical association between SSRI use in pregnancy and PPHN-Serotonin syndromeCitalopram is excreted in human breast milk, caution should be exercised and breastfeeding infants should be observed for adverse reactions when administering to nursing women. Some reports of infants experiencing excessive somnolence, decreased feedings, and weight lossReports of excessive somnolence, decreased feeding, and weight loss in breastfed infants. However, majority of studies show no or limited side effects in breastfed infants. Risks of this product are quite low
SNRIs
Venlafaxine*CNo teratogenic effects reported; non-teratogenic effects included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia , tremor, jitteriness, irritability, and constant cryingVenlafaxine has been reported to be excreted in milk, potential for serious adverse reactions in nursing infants. A decision should be made to discontinue nursing or to discontinue the drugVenlafaxine does enter the milk in moderate amounts, however no side-effects have been reported following its lactational exposure
Duloxetine
(Cymbalta)
CNon-teratogenic effects included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia , tremor, jitteriness, irritability, and constant cryingThe safety of duloxetine in infants is not known, nursing while on Cymbalta is not recommendedMilk levels in one study (6 mothers) are low and the relative infant dose is low. Subsequent study suggests weight-adjusted infant dose of 0.14% of the maternal dose
Desvenlafaxine
(Pristiq)
CNeonates exposed to SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Non-teratogenic effects included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia , tremor, jitteriness, irritability, and constant cryingPotential for serious adverse reactions in nursing infants from PRISTIQDesvenlafaxine does enter the milk in moderate amounts, however no side-effects have been reported following its lactational exposure
DRIs
Bupropion
(Wellbutrin)
CNo increased risk of congenital malformations overallBupropion and its metabolites are present in human milk, exercise caution when administering to nursing womenPlasma levels in breastfed infants are undetectable, one case of seizure in 6-month old infant
5-HT2A Receptor Antagonists
Nefazodone *CPremature birth, infants drowsiness and lethargy, infant failure to thrive, and poor temperature controlIt is not known whether Nefazodone or its metabolites are excreted in human milk, caution should be exercised when administered to nursing womenMedication should not be used in breastfeeding mothers with young infants, premature infants, infants subject to apnea, or other weakened infants
SRIs
Trazodone
(Oleptro)
CIncreased fetal resorption, increase in congenital anomalies, may cause fetal harmOleptro use in pregnant and nursing women is not recommendedMilk levels are probably too low to be clinically relevant in the breastfed infant, did not report any pediatric concerns in breastfeeding infants
TeCAs
Miratazapine
(Remeron)
CNo evidence of teratogenic effectsRemeron may be excreted into breast milk, caution should be exercised in administering to nursing womenTwo studies found no adverse effects among infants of nursing mothers and suggest breastfeeding is safe during Miratazapine therapy

Note: No Black Box Warnings for Pregnant.

*

FDA Pregnancy Categories: Category C = Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of drug in pregnant women despite potential risks; Category D = There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Abbreviations: DRI = dopamine reuptake inhibitors; FDA = U.S. Food and Drug Administration; PPHN = persistent pulmonary hypertension of the newborn; SNRI = serotonin-norepinephrine reuptake inhibitors; SRI = serotonin reuptake inhibitors; SSRI = selective serotonin reuptake inhibitors; TeCA = tricyclic antidepressants.

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