Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) &amp; Pharmacovigilance Risk Assessment Committee (PRAC).

Damkier, Per

doi:10.22541/au.158465422.20540674

Cited by 4 publications

(1 citation statement)

References 5 publications

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“…28 Whereas, in 2019, European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) assessment report based on same epidemiological data suggest not to use ondansetron during first trimester pregnancy. 29 The present review included the cohort and register based more recent studies from various countries in which exposure and occurrence of outcome were verified using records or interview. Few studies conducted matched or adjusted statistical analysis and we considered adjusted data whenever available to reduce the heterogeneity between the groups to increase the strength of the present systematic review.…”

Section: Discussionmentioning

confidence: 99%

Ondansetron exposure during pregnancy is not associated with risk of congenital malformations: evidence from a meta-analysis

Sarada

Bakshi²,

Vadgaonkar³

et al. 2022

Int J Reprod Contracept Obstet Gynecol

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Ondansetron is widely used drug for treatment of morning sickness and hyperemesis gravidarum. However, whether exposure to ondansetron during pregnancy is associated with risk of congenital malformations or not remains debatable. The present meta-analysis was performed for published cohort/registry-based studies which evaluated the association between ondansetron exposure and risk of congenital malformations. Major congenital malformations were considered as the primary outcome measure. Specific abnormalities like cardiac malformation, septal defect, cleft lip/palate, hypospadias, and genitourinary abnormalities were considered as secondary outcome measures along with spontaneous abortion/miscarriage, stillbirth, preterm delivery, and low birth weight babies. Pooled analysis was done using the Mantle-Hanzle method, random effect model and were expressed as odds ratio (OR) with 95% CI. Fourteen studies were included in systematic review. There was no significant difference for major congenital malformations [n=12; OR: 1.12 (95% CI: 0.93-1.36), I2=96], septal defect [n=5; OR: 1.39 (95% CI: 1.01-1.91), I2=48%], cleft lip/palate [n=3; OR: 1.11 (95% CI: 0.80-1.53), I2=41%] between ondansetron exposed and control arms. However, a greater number of events were found in control arm than intervention arm for cardiac defect [n=7; OR: 1.26 (95% CI: 1.09-1.45), I2=71%; p=0.002]. We also observed a greater number of events for stillbirth and pre-term labour in control arm than in intervention arm with OR: 1.57 (95% CI: 1.24-1.97); p=0.0001 and OR: 1.33 (95% CI: 1.05-1.69); p=0.02, respectively. This meta-analysis concludes that ondansetron exposure during pregnancy is not associated with any increased risk of major congenital malformations, septal /cardiac defect, cleft lip/palate, spontaneous abortion/miscarriage, stillbirth, pre-term labour and low birth weight babies.

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Section: Discussionmentioning

confidence: 99%

Ondansetron exposure during pregnancy is not associated with risk of congenital malformations: evidence from a meta-analysis

Sarada

Bakshi²,

Vadgaonkar³

et al. 2022

Int J Reprod Contracept Obstet Gynecol

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Postmarketing Safety Monitoring After Influenza Vaccination Using a Mobile Health App: Prospective Longitudinal Feasibility Study (Preprint)

Nguyen¹,

Krause²,

Keller‐Stanislawski³

et al. 2020

Preprint

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BACKGROUND For the safety monitoring of vaccinations postlicensure, reports of adverse events after immunization (AEFIs) are crucial. New technologies such as digital mobile apps can be used as an active approach to capture these events. We therefore conducted a feasibility study among recipients of the influenza vaccination using an app for assessment of the reporting of AEFIs. OBJECTIVE The goal of the research was to determine factors influencing adherence to and correct use of a newly developed app for individuals to report AEFI for 3 months using regular reminder functions, to identify determinants of AEFI occurrence and define reported AEFI types. METHODS We developed the app (SafeVac) and offered it to recipients of the influenza vaccination in 3 occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFIs were generated through SafeVac for 3 months. Using logistic and Cox regression, we assessed associations between app adherence, correct app entry, AEFIs, and sociodemographic parameters. RESULTS Of the individuals who logged into SafeVac, 61.4% (207/337) used the app throughout a 3-month period. App use adherence was negatively associated with female sex (odds ratio [OR] 0.47; CI 0.25-0.91) and correct app entry was negatively associated with older age (OR 0.96; CI 0.93-0.99) and lower education (OR 0.31; CI 0.13-0.76). AEFI occurrence was associated with female sex (hazard ratio 1.41; CI 1.01-1.96) and negatively with older age (hazard ratio 0.98; CI 0.97-0.99). The most common AEFIs reported were injection site pain (106/337), pain in extremity (103/337), and fatigue/asthenia (73/337). CONCLUSIONS Digital AEFI reporting was feasible with SafeVac and generated plausible results for this observation period and setting. Studies directly comparing SafeVac with conventional passive reporting schemes could determine whether such digital approaches improve completeness, timeliness, and sensitivity of vaccine vigilance. Further studies should evaluate if these results are transferable to other vaccinations and populations and if introduction of such a tool has an influence on vaccination readiness and therefore vaccine safety.

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Structured Benefit-Risk Assessments: An Illustrative Case Study of Paracetamol.

Piccirillo

Parish

2022

Glob Clin Transl Res

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This paper aims to provide an overview of the steps in developing a structured benefit-risk assessment, along with a simple, salient, and timely example of its implications. Using the time-tested, non-prescription drug paracetamol (a.k.a. acetaminophen) as an example, we demonstrate the fundamental role a well-structured benefit-risk assessment may play in clarifying the safety profile of even well-established medicinal products. The benefit-risk balance assessment performed by drug manufacturers and others involved in keeping drugs on the market is integral to a non-stop drug safety assessment continuum throughout a product’s lifecycle. This provides further reassurance that, as the world grapples with new diseases, pharmacovigilance systems with robust tools such as structured benefit-risk assessments can evolve and adapt by developing essential preventive and mitigative strategies. All these examples and practices contain the through-line of consideration for the protection of public health, a foundational cornerstone of pharmacovigilance practice. While a wealth of information may be explored on each aspect of the presented topics, the authors aim to give even those readers with only minimal background in pharmacovigilance an appreciation for the value of structured benefit-risk assessments.

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Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC).

Cited by 4 publications

References 5 publications

Ondansetron exposure during pregnancy is not associated with risk of congenital malformations: evidence from a meta-analysis

Ondansetron exposure during pregnancy is not associated with risk of congenital malformations: evidence from a meta-analysis

Postmarketing Safety Monitoring After Influenza Vaccination Using a Mobile Health App: Prospective Longitudinal Feasibility Study (Preprint)

Structured Benefit-Risk Assessments: An Illustrative Case Study of Paracetamol.

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