The safety of serotonin–noradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review

Bellantuono, Cesario; Vargas, M W; Mandarelli, Gabriele; Nardi, Bernardo; Martini, Maria Giulia

doi:10.1002/hup.2473

Cited by 43 publications

(26 citation statements)

References 62 publications

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“…Venlafaxine was also judged as relatively safe during pregnancy (relating to major malformations) but the authors could not draw a definite conclusion regarding breastfeeding [31]. …”

Section: Resultsmentioning

confidence: 99%

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic

et al. 2017

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IntroductionTapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009.MethodsThis is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials.ResultsThe first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses.ConclusionMore than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population.FundingGrünenthal GmbH.Electronic supplementary materialThe online version of this article (10.1007/s12325-017-0654-0) contains supplementary material, which is available to authorized users.

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“…Venlafaxine was also judged as relatively safe during pregnancy (relating to major malformations) but the authors could not draw a definite conclusion regarding breastfeeding [31]. …”

Section: Resultsmentioning

confidence: 99%

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic

et al. 2017

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“…Two recent systematic reviews found no association between first trimester exposure to venlafaxine and an increased risk for major congenital malformations . Conversely, studies have found a possible association with an increased risk for some perinatal complications, including a withdrawal syndrome with venlafaxine use in the third trimester . The amount of data for duloxetine is much smaller but does not suggest a clinically important increased risk for major malformations.…”

Section: Methodsmentioning

confidence: 93%

“…A small number of studies have evaluated outcomes following SNRI (venlafaxine or duloxetine) use in pregnancy and have found no major teratogenic effects . Two recent systematic reviews found no association between first trimester exposure to venlafaxine and an increased risk for major congenital malformations . Conversely, studies have found a possible association with an increased risk for some perinatal complications, including a withdrawal syndrome with venlafaxine use in the third trimester .…”

Section: Methodsmentioning

confidence: 99%

Medication Use and Pain Management in Pregnancy: A Critical Review

Black¹,

Khor

Kennedy

et al. 2019

Pain Practice

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Background Pain during pregnancy is common, and its management is complex. Certain analgesics may increase the risk for adverse fetal and pregnancy outcomes, while poorly managed pain can result in adverse maternal outcomes such as depression and hypertension. Guidelines to assist clinicians in assessing risks and benefits of exposure to analgesics for the mother and unborn infant are lacking, necessitating evidence‐based recommendations for managing pain in pregnancy. Methods A comprehensive literature search was conducted to assess pregnancy safety data for pharmacological and nonpharmacological pain management methods. Relevant clinical trials and observational studies were identified using multiple medical databases, and included studies were evaluated for quality and possible biases. Results Paracetamol and nonsteroidal anti‐inflammatory drugs (NSAIDs) are appropriate for mild to moderate pain, but NSAIDs should be avoided in the third trimester due to established risks. Short courses of weaker opioids are generally safe in pregnancy, although neonatal abstinence syndrome must be monitored following third trimester exposure. Limited safety data for pregabalin and gabapentin indicate that these are unlikely to be major teratogens, and tricyclic antidepressants and serotonin‐norepinephrine reuptake inhibitors have limited but overall reassuring safety data. Many of the included studies were limited by methodological issues. Conclusions Findings from this review can guide clinicians in their decision to prescribe analgesics for pregnant women. Treatment should be tailored to the lowest therapeutic dose and shortest possible duration, and management should involve a discussion of risks and benefits and monitoring for response. Further research is required to better understand the safety profile of various analgesics in pregnancy.

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“…duloxetine and venlafaxine) during pregnancy does not seem to be consistently associated with an increased risk of birth defects, but use of these medications has been associated with an increased risk of postpartum hemorrhage, and venlafaxine in particular has been associated with an increased risk of hypertension during pregnancy [221,222,223]. However, it is important to remember that the data investigating the safety of exposure to SNRIs during pregnancy are not as extensive as those for SSRIs.…”

Section: Risks During Pregnancy and Breast Feedingmentioning

confidence: 99%

“…These reactions at least to a certain extent may be conceptualized as discontinuation or withdrawal syndromes [230]. In fact, paroxetine and venlafaxine, two antidepressants with relatively short half-lives, have been especially associated with withdrawal reactions [223]. …”

Section: Risks During Pregnancy and Breast Feedingmentioning

confidence: 99%

The Safety, Tolerability and Risks Associated with the Use of Newer Generation Antidepressant Drugs: A Critical Review of the Literature

Carvalho

Sharma²,

Brunoni³

et al. 2016

Psychother Psychosom

490

324

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Newer generation antidepressant drugs (ADs) are widely used as the first line of treatment for major depressive disorders and are considered to be safer than tricyclic agents. In this critical review, we evaluated the literature on adverse events, tolerability and safety of selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors, bupropion, mirtazapine, trazodone, agomelatine, vilazodone, levomilnacipran and vortioxetine. Several side effects are transient and may disappear after a few weeks following treatment initiation, but potentially serious adverse events may persist or ensue later. They encompass gastrointestinal symptoms (nausea, diarrhea, gastric bleeding, dyspepsia), hepatotoxicity, weight gain and metabolic abnormalities, cardiovascular disturbances (heart rate, QT interval prolongation, hypertension, orthostatic hypotension), genitourinary symptoms (urinary retention, incontinence), sexual dysfunction, hyponatremia, osteoporosis and risk of fractures, bleeding, central nervous system disturbances (lowering of seizure threshold, extrapyramidal side effects, cognitive disturbances), sweating, sleep disturbances, affective disturbances (apathy, switches, paradoxical effects), ophthalmic manifestations (glaucoma, cataract) and hyperprolactinemia. At times, such adverse events may persist after drug discontinuation, yielding iatrogenic comorbidity. Other areas of concern involve suicidality, safety in overdose, discontinuation syndromes, risks during pregnancy and breast feeding, as well as risk of malignancies. Thus, the rational selection of ADs should consider the potential benefits and risks, likelihood of responsiveness to the treatment option and vulnerability to adverse events. The findings of this review should alert the physician to carefully review the appropriateness of AD prescription on an individual basis and to consider alternative treatments if available.

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The safety of serotonin–noradrenaline reuptake inhibitors (SNRIs) in pregnancy and breastfeeding: a comprehensive review

Cited by 43 publications

References 62 publications

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic

Medication Use and Pain Management in Pregnancy: A Critical Review

The Safety, Tolerability and Risks Associated with the Use of Newer Generation Antidepressant Drugs: A Critical Review of the Literature

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