Ondansetron for nausea and vomiting in pregnancy: re-evaluating the teratogenic risk

Michie, Louise A; Hodson, Kenneth

doi:10.1177/1753495x20914967

Cited by 7 publications

(6 citation statements)

References 5 publications

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“…At the time of the study, the EMA had announced a warning for using ondansetron during early pregnancy due to a potential link to orofacial clefts [17]. This was probably a reason for the inconsistencies in pregnancy recommendations for ondansetron, since some recommendations were published before this announcement.…”

Section: Discussionmentioning

confidence: 99%

Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study

Nörby¹,

Noël-Cuppers

Hristoskova

et al. 2021

Expert Opinion on Drug Safety

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Background: Inconsistencies in information on safety of medicine use during pregnancy and lactation can result in sub-optimal treatment for pregnant and lactating women, risks to the fetus or child and unnecessary weaning off breastfeeding. The objective of this study was to analyze information discrepancies regarding medicine use during pregnancy and lactation between on-line sources for patients and health care professionals (HCPs) in four European languages. Research design and methods: The medicines analyzed were ibuprofen, ondansetron, olanzapine, fingolimod, methylphenidate and adalimumab. Recommendations were classified into different data source categories, for patients and for HCPs, and compared between the data source categories for each medicine and language. Results: For patients, 11/24 (46%) and 4/24 (17%) comparisons of the pregnancy and lactation recommendations, respectively, were consistent between all sources. The corresponding figures for HCP-sources were 13/24 (54%) and 5/24 (21%). Regulatory sources had generally more restrictive recommendations. Teratology Information Services (TIS) centers' recommendations for medicine use during pregnancy and lactation were consistent in 25/27 (93%) and 15/22 (68%) of cases respectively. Conclusion: Discrepancies between online information sources regarding medicine use during pregnancy and lactation are common, especially for lactation. TIS centers recommendations were more aligned. Additional work is needed to harmonize information within and between countries to avoid conflicting messages.

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Section: Discussionmentioning

confidence: 99%

Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study

Nörby¹,

Noël-Cuppers

Hristoskova

et al. 2021

Expert Opinion on Drug Safety

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show abstract

“…Recently, a meta-analysis [23] that studied 12 papers, concluded that there is an increased risk of ventricular septal defects (OR = 1.11) and cleft lip (OR = 1.22) and perhaps cleft palate (OR = 1.48). Although this perception of risk must be balanced against the increase in absolute risk, which still seems to be small [24], we understand that the use of this medication should be done with caution, reserving its prescription for more serious cases.…”

Section: Drug Treatmentmentioning

confidence: 99%

Demographic, Clinical, and Obstetrical Characterization of Women with Hyperemesis Gravidarum Using a More Restrictive Diagnosis

Galletta¹,

Demo²,

Pinto³

et al. 2022

Clin. Exp. Obstet. Gynecol.

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Background: Hyperemesis gravidarum (HG) is a disease that occurs during pregnancy. It is relatively rare (0.3-3.6%), but with great potential for complications. Its diagnostic criteria still lack consensus, and most studies only establish the presence of uncontrollable vomiting, requiring hospitalization. The present study aimed to investigate its epidemiological profile and maternal and neonatal outcomes in a series of cases with more restrictive diagnostic criteria. Methods: A retrospective analysis of all cases admitted with a diagnosis of HG, according to more restrictive service criteria, was performed with a review of medical records and laboratory tests in a Brazilian university hospital. Results: HG was confirmed in 85 cases (0.39% incidence). The most frequent early symptoms included a weight loss ≥5% (94.4%) or ≥10% (63.9%), dehydration (76.5%), hyponatremia (49.4%), hypokalemia (40.5%), increased liver enzymes (46.4%), and transient hyperthyroidism (38.6%). Enteral nutrition was used in 7.1% of the patients, and parenteral nutrition in 1.2%. A large majority of patients was provided with a prescription of more than one drug, and the most used drugs were dimenhydrinate (87.1%), metoclopramide (85.9%), and ondansetron (38.8%). The average length of hospital stay was 15 days (1-145 days). Childbirth data were obtained from 40 patients, with 60% of births being cesarean deliveries, 35.3% premature births, 32% with low birth weight, and 7.5% stillbirths, with 12.5% of cases having postpartum complications. The overall rate for clinical complications was 30.5%. Conclusions: With well-defined and more restrictive criteria, we observed a high rate of obstetric and neonatal complications compared to international data. Thus, a correct diagnosis is essential for identifying this serious condition and to allow earlier treatment, reducing clinical, obstetric, and neonatal complications.

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“…Inconsistent data has suggested a possible association between both ondansetron and corticosteroid use and an increased risk of fetal orofacial abnormalities but expert teratologists have supported their use. 23,24 Aim for oral therapy unless planning inpatient management. Rectal or continuous subcutaneous therapy may have a role but no options are currently available in Australia and New Zealand.…”

Section: Trial Of Oral Intakementioning

confidence: 99%

Review article: Management of hyperemesis gravidarum and nausea and vomiting in pregnancy

Löwe

Steinweg

2021

Emerg Medicine Australasia

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Nausea and vomiting in pregnancy (NVP) are common in early pregnancy but there is a wide spectrum of severity in terms of the duration and acuity of symptoms throughout gestation. Adverse maternal and fetal outcomes have been seen in women who experience severe symptoms, also known as hyperemesis gravidarum (HG). Evidence-based, assessment and management can reduce symptom severity, avoid physical and psychological deterioration and minimise the impact on quality of life and function. A pathway for assessment and management of NVP and HG in the emergency room is presented based on the Society of Obstetric Medicine of Australia and New Zealand Guideline for the Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum. Assessment requires an objective evaluation using a validated scoring system such as the PUQE-24 score, as well as calculation of hydration and nutritional status. Ketonuria is not associated with either the diagnosis or severity of HG. Further investigation including biochemistry is only required in severe cases. Many women will have tried a range of therapies and an important aspect of treatment is to recognise the validity of their symptoms. Treatment may require a combination of intravenous fluids, anti-emetics, acid suppression and laxatives. Outpatient management is optimal but admission may be required for refractory symptoms, organ dysfunction or concurrent significant co-morbidities. Emergency management of NVP and HG requires an appropriate pathway of care to support women until the natural resolution of their condition. Both underuse of safe therapies and overuse of ineffective medication must be avoided.

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Ondansetron for nausea and vomiting in pregnancy: re-evaluating the teratogenic risk

Cited by 7 publications

References 5 publications

Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study

Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study

Demographic, Clinical, and Obstetrical Characterization of Women with Hyperemesis Gravidarum Using a More Restrictive Diagnosis

Review article: Management of hyperemesis gravidarum and nausea and vomiting in pregnancy

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