Use of ondansetron during pregnancy and congenital malformations in the infant

Danielsson, Bengt; Wikner, Birgitta Norstedt; Källén, Bëngt

doi:10.1016/j.reprotox.2014.10.017

Cited by 85 publications

(60 citation statements)

References 12 publications

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“…Some studies have shown no significant increase of adverse fetal outcomes when ondansetron was taken during early pregnancy (Einarson et al, 2004; Pasternak et al, 2013). In contrast, other studies including a systematic review of women who had taken ondansetron in early pregnancy found that the teratogenic risk with ondansetron is low but an increased risk for a cardiac septum defect is likely (Carstairs, 2016; Danielsson et al, 2014). Finally, a recent review about ondansetron safety during pregnancy concluded that there is insufficient evidence of harm to preclude its use in pregnancy (Siminerio et al, 2016).…”

Section: Treatmentmentioning

confidence: 87%

Nausea and vomiting of pregnancy - What's new?

Bustos

Venkataramanan²,

Caritis

2017

Autonomic Neuroscience

117

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Nausea and vomiting of pregnancy (NVP) is one of the most common disorders of pregnancy. The symptoms occur predominantly during the first trimester, although in a subgroup of patients they can continue throughout the entire pregnancy and can affect the woman’s quality of life. A small percentage of women develop a severe form of NVP called hyperemesis gravidarum (HG) that if left untreated may lead to significant maternal morbidity and adverse birth outcomes. Overall, the morbidity in pregnant women with NVP is significant, although it tends to be underestimated. The pathogenesis of NVP remains unclear, but there is consensus that the disorder is multifactorial and that various genetic, endocrine and infectious factors may be involved. The treatment of NVP can be challenging as the optimal targets for therapy are not known. Currently, the therapy used depends on the severity of the disorder and it is focused on improving the symptoms while minimizing risks to mother and fetus. Therapies range from dietary changes, pharmacologic treatment or hospitalization with intravenous fluid replacement and nutrition therapy. The aims of this review are 1) to provide an overview of NVP, 2) to present possible links between the most important factors associated with the pathogenesis of NVP and 3) to discuss the effectiveness and safety of the pharmacologic and non-pharmacologic options available to treat this disorder.

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Section: Treatmentmentioning

confidence: 87%

Nausea and vomiting of pregnancy - What's new?

Bustos

Venkataramanan²,

Caritis

2017

Autonomic Neuroscience

117

View full text Add to dashboard Cite

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“…60 In 2011, Anderka et al 61 published data showing a 2-fold increased risk in cleft palate for offspring of mothers using ondansetron. Danielsson et al 62 found a statistically significant increase in fetal risk for a cardiovascular defect (primarily a septal defect). Although multiple studies show a small, but significant, risk for ondansetron causing fetal teratogenesis after administration to pregnant female subjects, other studies refute this finding.…”

Section: Ondansetronmentioning

confidence: 99%

“…Although multiple studies show a small, but significant, risk for ondansetron causing fetal teratogenesis after administration to pregnant female subjects, other studies refute this finding. 62 …”

Section: Ondansetronmentioning

confidence: 99%

Drugs and Medical Devices: Adverse Events and the Impact on Women’s Health

Carey

Nader

Chai

et al. 2017

Clinical Therapeutics

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A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women.

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“…Evidence exists for safety of the most frequently used treatments, including metoclopramide and antihistamines 4748495051. Most studies found no association between maternal ondansetron use in early pregnancy and congenital anomalies, but there is inconsistent evidence for a small increase in congenital heart disease associated with ondansetron 49. Nonetheless, the Royal College of Obstetricians and Gynaecologists’ (RCOG) guideline considers ondansetron safe and recommends its use.…”

Section: What Treatments Are Available?mentioning

confidence: 99%