The Safety of Duloxetine During Pregnancy and Lactation

Andrade, Chittaranjan

doi:10.4088/jcp.14f09631

Cited by 24 publications

(20 citation statements)

References 39 publications

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“…Our review identifies significantly more data than a new review on venlafaxine reporting about 900 exposures , and about twice the amount of duloxetine data than discussed in a recent commentary .…”

Section: Discussionmentioning

confidence: 84%

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First‐Trimester Pregnancy Exposure to Venlafaxine or Duloxetine and Risk of Major Congenital Malformations: A Systematic Review

Lassen

Ennis

Damkier

2015

Basic Clin Pharma Tox

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Major depressive disorder is common among women in child-bearing age, and medical treatment is subject to substantial discussions and controversies. For Selective Serotonin reuptake inhibitors, SSRIs, a vast amount of data are available. For the newer antidepressant group of serotonin and noradrenaline reuptake inhibitors, SNRIs, significantly less data are available. Following the PRISMA guideline for systematic reviews, we performed a systematic search on the risk of major congenital malformations after first trimester in utero exposure to venlafaxine or duloxetine. We identified eight cohort studies reporting on the outcome upon in utero exposure to venlafaxine or duloxetine during the first trimester. The cumulated data for venlafaxine were 3186 exposed infants and 107 major malformations, resulting in a relative risk estimate and 95% confidence interval of 1.12 (0.92-1.35). The corresponding data for duloxetine were 668 infants and 16 major malformations, resulting in a relative risk estimate and 95% confidence interval of 0.80 (0.46-1.29). First-trimester in utero exposure to venlafaxine is not associated with an increased risk of major congenital malformations. The amount of data for duloxetine are significantly smaller but does not suggest a clinically important increased risk.Depression is common among women of child-bearing age. Approximately 20% of all women of child-bearing age will experience a depression during their life time, and 1% to 8% will use an antidepressant drug during pregnancy [1]. Untreated depression during pregnancy carries risk of severe consequences to the pregnant mother and her unborn child such as: epidural analgesia, caesarean section, intensive ward admission, preterm delivery, low birthweight, and disturbances in the child's neurocognitive and socio-emotional development [2]. Untreated depression during pregnancy increases the risk of post-partum depression 6-fold [3,4].The controversy of possible untoward foetal effects after in utero exposure to selective serotonin receptor inhibitors (SSRIs) has been ongoing for more than a decade. Data on more than 50,000 first-trimester SSRI-exposed newborn have accumulated, and it is accepted that first-trimester exposure to any antidepressant does not result in an overall increased risk of congenital malformations. The risk of cardiovascular malformations is still somewhat unclear, but if true, absolute risks are minor and may pertain to specific SSRIs, especially paroxetine and fluoxetine [5][6][7][8][9][10]. Comparatively, pregnancy data on the newer combined serotonin/noradrenaline receptor inhibitors (SNRI), venlafaxine and duloxetine, are scarce. A recent large Scandinavian study did not suggest an increased risk associated with venlafaxine [10], and a recent commentary concluded that the amount of information for duloxetine was too little [11].Current guidelines are vague and offer little decision support. The NICE guideline does not distinguish between the various types of antidepressants and offers no direct suggestio...

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Section: Discussionmentioning

confidence: 84%

“…Comparatively, pregnancy data on the newer combined serotonin/noradrenaline receptor inhibitors (SNRI), venlafaxine and duloxetine, are scarce. A recent large Scandinavian study did not suggest an increased risk associated with venlafaxine , and a recent commentary concluded that the amount of information for duloxetine was too little .…”

mentioning

confidence: 99%

First‐Trimester Pregnancy Exposure to Venlafaxine or Duloxetine and Risk of Major Congenital Malformations: A Systematic Review

Lassen

Ennis

Damkier

2015

Basic Clin Pharma Tox

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“…One study from 2014 however showed controversial results contradictory to those above, finding a one to three times increased relative risk of spontaneous abortion for the use of duloxetine during pregnancy 21 .…”

Section: Discussionmentioning

confidence: 92%

Pregnancy Outcomes in Maternal Neuropsychiatric Illness and Substance Abuse

Bartel

Costa

Kropf

et al. 2017

Geburtshilfe Frauenheilkd

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Introduction Worldwide the prevalence of neuropsychiatric illness among women of reproductive age is higher than ever before. This study investigates the influences of maternal substance abuse/dependence and neuropsychiatric illness on pregnancy and neonatal outcomes. Patients and Methods Using a retrospective study design 185 pregnancies in women with neuropsychiatric illnesses or substance abuse were identified at a single centre over a period of 3.25 years and compared to 4907 pregnancies in healthy women without mental illness. Differences in pre-, peri- and postnatal pregnancy parameters were studied. Results Numbers of previous abortions on obstetric history were significantly higher in cases compared to controls, women with depression being especially affected. The number of antenatal visits was also higher among cases, especially in women with depression. The caesarean section rate was significantly higher in cases compared to controls. Children of women with neuropsychiatric illness were born at lower gestational ages than those of healthy control mothers, however there were no significant differences between case and control groups for birth weight, head circumference or Apgar scores. Some isolated differences were found for disease-specific case subgroups compared to controls. Conclusion The study shows a relationship between maternal neuropsychiatric illness and pregnancy outcomes independent of medication use. Rates of spontaneous abortion were higher. Children were born earlier, yet the neonatal outcomes birth weight, head circumference and Apgar score were not worse than children of mentally healthy women.

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“…The decision regarding the use of medication would have been better informed if the patient had had a trial off medication prior to conception. For duloxetine, other than an increased risk of spontaneous abortion, evidence, although limited, shows no increased risk of malformation to the fetus above baseline and no increased risk of adverse outcomes (15). Therefore, Ms. A's depressive relapse may have been prevented if duloxetine had been continued throughout her pregnancy.…”

Section: Key Points/clinical Pearlsmentioning

confidence: 99%

Choosing and Discussing SSRIs for Depression in Pregnancy: A Basic Guide for Residents

Gorun

2018

AJP Residents' Journal

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The Safety of Duloxetine During Pregnancy and Lactation

Cited by 24 publications

References 39 publications

First‐Trimester Pregnancy Exposure to Venlafaxine or Duloxetine and Risk of Major Congenital Malformations: A Systematic Review

First‐Trimester Pregnancy Exposure to Venlafaxine or Duloxetine and Risk of Major Congenital Malformations: A Systematic Review

Pregnancy Outcomes in Maternal Neuropsychiatric Illness and Substance Abuse

Choosing and Discussing SSRIs for Depression in Pregnancy: A Basic Guide for Residents

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