Poor Neonatal Adaptation Syndrome Research Articles

Characteristics of breastfeeding newborns in the first month of life with in utero selective serotonin reuptake inhibitor medication exposure: a scoping review protocol.

The objective of this scoping review is to understand the extent and type of evidence in relation to the characteristics of breastfeeding newborns in the first month of life who have been exposed in utero to selective serotonin reuptake inhibitor (SSRI) medications. SSRIs are the most commonly prescribed antidepressant medication in pregnancy. Up to 30% of newborns who are prenatally exposed to SSRIs demonstrate withdrawal signs. Poor neonatal adaptation syndrome represents a constellation of signs observed in these newborns. Little information has been studied regarding breastfeeding, as it relates to the impact of in utero SSRI exposure on the newborn. Parents have many questions regarding the safety of taking medications during pregnancy and breastfeeding. It is important for health care providers to collate evidence-based information and facilitate shared decision-making. We aim to identify the approaches researchers have used to investigate in utero SSRI exposure among breastfed newborns to determine knowledge gaps. Primary peer-reviewed studies will be considered for inclusion according to the following criteria: newborns, 31 days of age or less, with in utero SSRI exposure in any trimester of pregnancy, who were breastfed or received breast-milk feedings. MEDLINE, CINAHL, Embase, LactMed, the Maternity and Infant Care Database, and ClinicalTrials.gov databases will be searched. JBI methodology will be used. Abstracts will be assessed for eligibility and full texts will be retrieved if they meet the inclusion criteria. Two reviewers will independently extract the data from identified studies using a data extraction form and the results will be summarized descriptively and in tabular format. Open Science Framework osf.io/2bt39.

Risk of poor neonatal adaptation syndrome similar with exposure to antipsychotics, antidepressants

The Brown University Psychopharmacology UpdateVolume 34, Issue 4 p. 7-7 Research Roundup Risk of poor neonatal adaptation syndrome similar with exposure to antipsychotics, antidepressants First published: 03 March 2023 https://doi.org/10.1002/pu.31001Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume34, Issue4April 2023Pages 7-7 RelatedInformation

Woman and pregnancy: focus on depression and psychopharmacological therapy

Perinatal depression is one of the most common complications of pregnancy: it affects about 10-15% of women; the object of clinical attentionis postpartum depression (PPD) because it involves a impairment of the social and personal functioning of affected women and can have repercussions on the partner on the quality of life, on mother-infant interaction and neurodevelopment of the product of conception. Selective serotonin reuptake inhibitors (SSRI) are generally consideredas first-line antidepressant treatment in pregnancy, as they are generally safe and effective. Studies concerning the adverse effects of exposure to SSRIs during pregnancy on the developing foetushaveindicated an increased risk of various congenital malformations and un toward effects such as poor neonatal adaptation syndrome or persistent pulmonary hypertension, but here still remain inconsistencies between various study results. PPD can be a preventable disorder, there fore it be comes important that integrated actions between different medical sectors (interdisciplinary), diagnosis and any interventions are effective.

Risk of Poor Neonatal Adaptation Syndrome Among Infants Exposed to Second-Generation Atypical Antipsychotics Compared to Antidepressants: Results From the National Pregnancy Registry for Psychiatric Medications.

Objective: While poor neonatal adaptation syndrome (PNAS) has been particularly well described among infants exposed to antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), this is not the case for second-generation antipsychotics (SGAs). In 2011, the US Food and Drug Administration (FDA) issued a drug safety warning regarding fetal antipsychotic exposure and risk for PNAS and extrapyramidal symptoms (EPS). The primary objective of this study was to examine the risk for PNAS among infants exposed to SGAs compared to SSRI/SNRI-exposed infants, leveraging the prospective, longitudinal design of the National Pregnancy Registry for Psychiatric Medications (NPRPM). Methods: The NPRPM is a prospective pharmacovigilance program in which pregnant women, aged 18–45 years, are enrolled and followed prospectively. Medical records were systematically reviewed and data abstracted using a checklist of PNAS and EPS symptoms specifically outlined in the FDA drug safety warning. The two study groups included infants exposed to an SGA during pregnancy and infants exposed to an SSRI/SNRI during pregnancy. The primary outcome was the presence of at least one or more PNAS symptoms during the first month of life. Other neonatal outcomes following exposure to the medication of interest, including preterm birth, neonatal intensive care unit (NICU) admission, rates of EPS, and whether infants were discharged home with their mothers, are also reported. Results: Of the 2,145 women enrolled in this study as of December 16, 2020, a total of 373 women and their infants (n = 384) were eligible for inclusion (n = 193 SGA-exposed infants and 191 SSRI/SNRI-exposed infants). Among SGA-exposed infants, 32.6% (63/193) experienced at least 1 PNAS sign compared to 34.6% of infants (66/191) in the SSRI/SNRI-exposed group. The majority of infants in each group showed no symptoms of PNAS. No differences were observed between the two groups with respect to rates of preterm birth, NICU admission, prevalence of EPS, and timing of infants being discharged home with their mothers. Conclusions: PNAS symptomatology was comparable among infants exposed prenatally to an SGA or to an SSRI/SNRI. These preliminary findings provide an estimated risk of PNAS among infants exposed to SGAs of roughly 30%. Interestingly, these findings are also consistent with estimates in the literature of PNAS in SSRI/SNRI-exposed infants, suggesting a possible common pathway underlying this phenomenon. Trial Registration: ClinicalTrials.gov identifier: NCT01246765

Poor neonatal adaptation syndrome: Toward a clinical consensus to guide research and counseling

Poor neonatal adaptation syndrome: Toward a clinical consensus to guide research and counseling

Neonatal outcome and adaption after in utero exposure to antidepressants: A systematic review and meta-analysis.

Major depressive disorder (MDD) and anxiety disorders are both common and especially challenging during pregnancy. Considering possible risks of intrauterine drug exposure of the child, the role of psychopharmacological treatment is ambiguous and various negative obstetric outcomes were inconsistently associated with medication. Consequently, a critical examination of peri- and postnatal phenomena associated with intrauterine exposure to antidepressants based on serotonin reuptake inhibition (SRI) and subsumed under the term "poor neonatal adaptation syndrome" (PNAS) is urgently called for. A comprehensive literature search was conducted, revealing a total number of 33 relevant studies and 69 individual outcomes among 3025 screened studies. Seventeen outcomes allowed meta-analytic evaluation (random effects model). Measures for heterogeneity (I2 ) and contour-enhanced funnel plots were generated. Single studies showed increased risks for deficits in neurological functioning and autonomous adaptation in SRI exposed infants. Meta-analytical evaluation showed increased symptom occurrence or severity in exposed neonates for low APGAR scores, birth weight, size for gestational age, preterm delivery, neuromuscular and autonomous regulation, and higher rates of admission to specialized care. Mostly, increased risk after SRI exposure was supported by comparison to unexposed infants born to mothers diagnosed with depression. Whereas statistically significant evidence for various effects of intrauterine exposure to SRI was found, the clinical relevance remains unresolved because of inherently low data quality in this research domain and insufficiently defined samples and outcomes. More systematic research under ethical considerations is required to improve multiprofessional counseling in the many women dealing with MDD during pregnancy and the peripartum.

Selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors in pregnancy: Infant and childhood outcomes.

This position statement provides guidance for the monitoring, care, and follow-up of newborns exposed to selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) in utero. Depression and anxiety are common during pregnancy and postpartum. While there are risks to taking medications during pregnancy, untreated or incompletely managed depression and anxiety also carry risks for the newborn. Poor neonatal adaptation syndrome (PNAS) occurs in one-third of newborns exposed to SSRIs or SNRIs in utero, and is generally mild and self-limiting. The low levels of SSRIs and SNRIs excreted in breast milk are compatible with breastfeeding. Persistent pulmonary hypertension of the newborn and congenital heart defects are rare associations of exposure to SSRIs or SNRIs in utero. There are inconsistencies in the literature regarding neurodevelopmental outcomes, specifically autism spectrum disorder and attention-deficit hyperactivity disorder. The inconsistencies likely relate to other factors (i.e., genetics, maternal depression, lifestyle, and comorbidities), rather than exposure to SSRIs or SNRIs in utero. Health care providers and parents should be reassured that PNAS is generally treatable with nonpharmacological measures, and that the risk of serious adverse effects from exposure to SSRIs or SNRIs in utero is low.

Neonatal Outcomes in Maternal Depression in Relation to Intrauterine Drug Exposure.

Background: SSRIs (Selective Serotonin Reuptake Inhibitors) are the most useful drugs to treat depression during pregnancy. Intrauterine exposure to SSRIs may increase the risk of growth restriction, preterm birth and neonatal complications. However, advantages in treating depression seem to exceed potential drug side effects in respect un-treated depression. SSRIs undergo extensive hepatic first-pass metabolism with the involvement of several cytochrome P450 (CYPs) enzymes. Genetic polymorphisms may influence the expression and activity of CYPs genes. The first aim of this study was to evaluate neonatal outcomes in depressed mothers exposed to SSRIs during pregnancy. SSRIs pharmacogenetics was also evaluated in a subset of mothers and fetuses.Methods: In this case-control study, cases (n = 42) were Caucasian women with a diagnosis of depression and/or anxiety, treated with SSRIs for the whole pregnancy. Controls (n = 85) were Caucasian women without a psychiatric diagnosis and not exposed to SSRIs during pregnancy. Exclusion criteria for both groups were other psychotropic drugs, anti-epileptics, drug of abuse, alcohol addiction, maternal or fetal infectious diseases, fetal/neonatal chromosomal genetic abnormalities. Maternal and fetal blood samples were obtained at delivery to analyze genotype in 33 cases.Results: The population was homogenous for demographic, anthropometric, socio-economic and obstetric variables except for smoking and mean hemoglobin values before delivery. Obstetric features were comparable. Newborns exposed to SSRIs during fetal life were significantly more likely to be Low Birth Weight (LBW) (birth weight <2,500 g) (p = 0.01), had significantly lower mean Apgar scores at 1' (p = 0.006) and at 5' (p = 0.023) and worse Apgar distribution at 1' (p = 0.017) and at 5' (p = 0.013). Fifty-six percent of newborns presented one or more symptoms consistent with poor neonatal adaptation syndrome (PNAS). Pharmacogenetic analysis at delivery did not show significant differences in the frequencies of obstetric or neonatal complications in relation to polymorphisms.Conclusions: We found that newborns exposed to SSRIs are at increased risk of poor neonatal outcomes in terms of low birth weight, low Apgar scores and, clinically, poor neonatal adaptation syndrome. Preliminary pharmacogenetic analysis showed that the degree of CYPs alterations, that depends on polymorphisms, may influence neonatal outcomes.

The Effects of Gestational Use of Antidepressants and Antipsychotics on Neonatal Outcomes for Women With Severe Mental Illness

(Aust N Z J Obstet Gynaecol 2017;57:526–532) Approximately 4% to 7.6% of fetuses are exposed to psychotropic medications in pregnant women with mental illness. Negative neonatal outcomes and poor neonatal adaptation syndrome are strongly associated with selective serotonin reuptake inhibitor exposure in pregnancy. High rates of special care nursery (SCN) admission appear to be greater in fetuses of women with severe mental illness (SMI). This study aimed to analyze the association between psychotropic medication use and the rates of SCN admission in a cohort of women with SMI and to also examine the neonatal outcomes associated with third trimester exposure to antidepressant medication alone, antipsychotic medication alone, or a combination of both.

Effect of antidepressants use in pregnancy on foetus development and adverse effects in newborns.

Over the last few years, several reports on the safety of antidepressants use in pregnancy have been published. Studies concerning the adverse effects of exposure to selective serotonin reuptake inhibitors (SSRI) during pregnancy on the developing foetus have indicated an increased risk of various congenital malformations and untoward effects such as poor neonatal adaptation syndrome or persistent pulmonary hypertension, but there still remain inconsistencies between various study results. This paper aims at reviewing the literature on the risks of exposure to antidepressants during pregnancy. SSRIs are generally considered as first-line antidepressant treatment in pregnancy, as they are generally safe and effective. To minimize the teratogenic risks, pregnant women should receive the minimal effective dose of the medication. Depression during pregnancy must not be left untreated, and it should also be remembered that the condition may extend into the postpartum period.

Mirtazapine in pregnancy and lactation – A systematic review

Depression is common in pregnancy and associated with increased risk of adverse effects for the neonate. Treatment and prevention options include antidepressant therapy. The aim of this paper was to review the literature on safety of mirtazapine during pregnancy and lactation. In 31 papers a total of 390 cases of neonates exposed to mirtazapine during pregnancy or lactation have been described. There might be an association between mirtazapine and spontaneous abortion, however, this might be attributable to underlying psychiatric disease.An increased risk of major neonatal malformations associated with mirtazapine in pregnancy has not been reported. Although one study showed a nearly significant increase in occurrence of respiratory problems and hypoglycaemia, no indication of causality could be given. No other significant adverse effects on neonates were reported. Limited available data, four papers on 11 exposed neonates, suggest that use of mirtazapine during breastfeeding is safe due to a low relative infant dose. High plasma levels might be associated with increased body weight and sleep. However, the reported data are too scarce to come to a clear assessment of the risk of mirtazapine in lactation.No information is available on the use of mirtazapine in pregnancy and Poor Neonatal Adaptation Syndrome (PNAS) or neurobehavioral development at an age over one year.In conclusion, mirtazapine seems to be safe in pregnancy, especially regarding incidence of congenital malformations. There are not enough data available to come to a conclusion on the safety of mirtazapine during lactation.

Mirtazapine in pregnancy and lactation: data from a case series.

Depression is a common disorder in pregnancy and associated with adverse effects for both mother and neonate. Pharmacological treatment and prevention options include mirtazapine. In a series of 56 cases, we investigated neonatal outcome after intrauterine exposure to mirtazapine and exposure through lactation in the first days postpartum.No increase in any neonatal complication was observed. None of the infants exposed to mirtazapine in the first trimester were born with a major malformation. Of the 54 infants exposed to mirtazapine in the third trimester, 14 were diagnosed with poor neonatal adaptation syndrome (PNAS). This incidence (25.9%) is similar to the incidence of PNAS after intrauterine exposure to other antidepressants. The incidence of PNAS after exposure to mirtazapine was significantly diminished in children who were partially or fully breastfed (18.6% versus 54.5%, P = 0.024).

The safety of duloxetine during pregnancy and lactation.

Depression is common in women, especially during pregnancy and the postpartum period. Untreated depression is associated with many adverse gestational outcomes. It is therefore important to know about the safety of different antidepressant drugs during pregnancy and lactation so that informed decisions can be made regarding treatment. This article summarizes published literature on the subject with regard to duloxetine, an antidepressant with serotonin-norepinephrine reuptake inhibition properties. In general, it appears that the use of duloxetine during pregnancy is associated with an increase in the risk of spontaneous abortion, but no increase in other adverse outcomes, such as major fetal malformations. Late-pregnancy exposure to duloxetine may be associated with poor neonatal adaptation syndrome, but the magnitude of this risk is not known. Infant exposure to duloxetine in breast milk is less than 1% of the maternal weight-adjusted dose, suggesting that duloxetine can be safely administered to a woman who is breastfeeding her infant. In general, the very limited data available on the subject do not uncover a signal that the use of duloxetine during pregnancy or lactation increases the risk of adverse outcomes.

Use of antidepressants during pregnancy: a better choice for some.

Mood disorders such as depression are more common among women, especially among pregnant women. Some population-based studies report a 20% prevalence of depression among pregnant women.[1],[2] Given this relatively high prevalence, the use of antidepressant medication during pregnancy is not uncommon. A study in the United States reported that at least 10% of pregnant women used antidepressants during pregnancy.[3] However, antidepressants may interfere with fetal growth so there is an ongoing debate about whether or not antidepressants should be used during pregnancy. Like all medications, antidepressants should be used with caution during pregnancy. The use of anti-depressants during pregnancy has been linked to various negative outcomes including miscarriage, pre-term birth, and low birth weight. One study found that within the two weeks of birth, newborns of mothers who used antidepressants during pregnancy were more likely to develop poor neonatal adaptation syndrome (OR=5.07, 95% CI=3.25-7.90), a condition which is characterized by poor temperature control, hypoglycemia, tachypnoea, respiratory distress, nasal congestion or cyanosis and seizures.[4] A systematic review reported a higher risk of developing congenital heart defects among newborns of mothers who used paroxetine during pregnancy (OR=1.36, 95% CI=1.08-1.71); however, this study did not find evidence of an overall association between the use of antidepressants and neonatal birth defects.[5] Untreated depression during pregnancy has been linked to more pre-term births and less breast-feeding.[6] Depression during pregnancy has also been associated with asthma in newborns, and the severity of depression was positively correlated with the severity of asthma (a dose-response relationship).[7] Moreover, the distress experienced by women with depression who are pregnant is similar to that experienced by women with depression who are not pregnant; the decline in their quality of life, impairment in their social functioning, and their risk of suicide are the same.[8] Therefore, treatment of depression during pregnancy is important for both the mother and the child. Psychotherapy, specifically interpersonal psycho-therapy,[9] has been shown to ameliorate depressive mood in pregnant women. However, this has only been studied among pregnant women with mild to moderate depression, not among those with severe depression for whom antidepressant treatment may be necessary. To date, there has been limited evidence about the effectiveness and safety of antidepressant use during pregnancy. Some experts have reached a consensus that antidepressants should be used to treat severe depression during pregnancy.[10] The Canadian Network for Mood and Anxiety Treatments (CANMAT) Clinical guidelines for the management of major depressive disorder in adults suggest weighing the adverse effects of antidepressants on the fetus (which occur at a low frequency) against the benefits of treatment. The guidelines list fluoxetine and other selective serotonin re-uptake antidepressants (SSRIs) as first-line antidepressants for use during pregnancy, but they also warn of possible neonatal heart defects after the use of fluoxetine.[11] A small-sample prospective study compared neonatal outcomes between 35 pregnant women who used antidepressants (mainly SSRI) with 23 pregnant women who did not. This study found no differences in cognitive functioning, language, and mobility in the babies at 18 months of age.[12] Another case report found no anomalies in the physical or mental development of a nine-month-old infant born to a mother who had taken duloxetine.[13] We believe that the benefits of antidepressant treatment of pregnant women with depression out-weigh the possible risk to the fetus: (a) if the depression is severe (that is, with suicidal ideation or behavior, psychotic symptoms, or a complete loss of appetite), (b) if there is a family history of re-occurring mental disorders, (c) if the individual lacks family or social support, or (d) if moderate depression persists despite psychotherapeutic treatment. Antidepressant use should be considered for the treatment of pregnant women who meet any of these criteria. The pros and cons of antidepressant treatment should be discussed with the individuals and their family members before obtaining their informed consent. Currently, most guidelines recommend the use of SSRIs (e.g., fluoxetine and citalopram) or tricyclic antidepressants (e.g., nortriptyline) for depression during pregnancy. Psychiatrists should ensure that the depressed woman and her family members are aware of the potential risks and immediately report any related symptoms. Psychiatrists treating pregnant women also need to coordinate their treatment with the responsible obstetrician to ensure the timely prevention of possible negative outcomes.

The Effect of Prenatal Antidepressant Exposure on Neonatal Adaptation

Conflicting reports on potential risks of antidepressant exposure during gestation for the infant have been reported in the literature. This systematic review and meta-analysis on immediate neonatal outcomes were conducted to clarify what, if any, risks are faced by infants exposed to antidepressants in utero. Subanalyses address known methodological limitations in the field. MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from their start dates to June 2010. Various combinations of keywords were utilized including, but not limited to, depressive/mood disorder, pregnancy/pregnancy trimesters, antidepressant drugs, and neonatal effects. English language and cohort and case-control studies reporting on a cluster of signs defined as poor neonatal adaptation syndrome (PNAS) or individual clinical signs (respiratory distress and tremors) associated with pharmacologic treatment were selected. Of 3,074 abstracts reviewed, 735 articles were retrieved and 12 were included in this analysis. Two independent reviewers extracted data and assessed the quality of the articles. Twelve studies were retrieved that examined PNAS or the signs of respiratory distress and tremors in the infant. There was a significant association between exposure to antidepressants during pregnancy and overall occurrence of PNAS (odds ratio [OR] = 5.07; 95% CI, 3.25-7.90; P < .0001). Respiratory distress (OR = 2.20; 95% CI, 1.81-2.66; P < .0001) and tremors (OR = 7.89; 95% CI, 3.33-18.73; P < .0001) were also significantly associated with antidepressant exposure. For the respiratory outcome, studies using convenience samples had significantly higher ORs (Q1 = 5.4, P = .020). No differences were found in any other moderator analyses. An increased risk of PNAS exists in infants exposed to antidepressant medication during pregnancy; respiratory distress and tremors also show associations. Neonatologists need to be prepared and updated in their management, and clinicians must inform their patients of this risk.

Pregnancy outcomes following gabapentin use

Our objectives were to 1) determine whether first-trimester use of gabapentin is associated with an increased risk for major malformations; 2) examine rates of spontaneous abortions, therapeutic abortions, stillbirths, mean birth weight and gestational age at delivery; and 3) examine rates of poor neonatal adaptation syndrome following late pregnancy exposure. The study design was prospective. Women were included who initially contacted the services between 5 and 8 weeks with a comparison group of women exposed to nonteratogens, collected in a similar manner. We have data on 223 pregnancy outcomes exposed to gabapentin and 223 unexposed pregnancies. The rates of major malformations were similar in both groups (p = 0.845). There was a higher rate of preterm births (p = 0.019) and low birth weight <2,500 g (p = 0.033) in the gabapentin group. Among infants who were exposed to gabapentin up until delivery, 23 of 61 (38%) were admitted to either the neonatal intensive care unit or special care nursery for observation and/or treatment, vs 6 of 201 (2.9%) live births in the comparison group (p < 0.001). There were 2 cases of possible poor neonatal adaptation syndrome in neonates exposed to gabapentin close to delivery, compared with none in the comparison group, although it must be noted that these infants were concomitantly exposed to other psychotropic drugs. Among the women who took gabapentin, the major indications were pain (n = 90; 43%) and epilepsy (n = 71; 34%); the remainder were for other indications, mostly psychiatric. Our results suggest that although this sample size is not large enough to make any definitive conclusions, and there was no comparator group treated with other antiepileptic drugs, gabapentin use in pregnancy does not appear to increase the risk for major malformations. This finding and the increased risk for low birth weight and preterm birth require further investigation.

Diagnosis and Management of Poor Neonatal Adaptation Syndrome in Newborns Exposed In Utero to Selective Seretonin/Norepinephrine Reuptake Inhibitors

During the last decade repeated studies have documented the existence of a poor neonatal adaptation syndrome in some newborns exposed to these drugs during pregnancy.1 While the syndrome includes features seen in neonatatal withdrawal of other psychotropic drugs (such as opioids, benzodiazepines, barbiturates, and alcohol), in the case of SSRIs and SNRIs the presentation is also characterized by respiratory distress, sometimes necessitating ventilatory support1 (Table 1). While the etiology of the poor adaptation syndrome is still debated, several findings may shed light on its pathophysiology:

Safety of Newer Antidepressants in Pregnancy

Pharmacotherapy for depression is often necessary during pregnancy. The information available about use of the newer antidepressants in pregnant women is limited by trial design and lack of long-term follow-up of exposed infants. Selective serotonin reuptake inhibitors (SSRIs) are not generally thought to be major teratogens. Some recent studies, however, have suggested that paroxetine may be associated with a small increase in risk of congenital abnormalities, particularly cardiac defects. Data on the effect of SSRIs on the incidence of preterm birth, spontaneous abortion, and fetal death are conflicting. Third-trimester exposure to newer antidepressants, including SSRIs and serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine), has been associated with a poor neonatal adaptation syndrome. In addition, SSRI use may be associated with an increased risk of persistent pulmonary hypertension of the newborn. Preliminary evidence suggests that SSRI exposure in utero does not have significant long-term effects on cognition or behavior. Based on limited information, mirtazapine, bupropion, and venlafaxine do not appear to be major teratogens. Little or no information is available on duloxetine.

Citalopram use in pregnancy: Prospective comparative evaluation of pregnancy and fetal outcome

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. 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. 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. 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.

New postmarketing surveillance data supports a lack of association between quinolone use in pregnancy and fetal and neonatal complications

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.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.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.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.