Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: content and utility analysis

Hawcutt, Daniel B; Russell, N Van Gelder; Maqsood, Hannah; Kouranloo, Koushan; Gomberg, Simon; Waitt, Catriona; Sharp, Andrew; Riordan, Andrew; Turner, Mark A.

doi:10.1111/bcp.13067

Cited by 19 publications

(18 citation statements)

References 42 publications

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“…Pharmacovigilance among infants exposed to drugs through breastfeeding is not well established, with under--reporting of adverse drug reactions, and a likely skew towards the most serious events 105 . Whilst few studies have systematically collected infant safety data, the recent PROMISE trial showed no increase in toxicities among infants exposed to ART through breast milk, compared to extended infant nevirapine prophylaxis 69 As women living with HIV in high--income settings question their eligibility to breastfeed, and women in LMIC are currently advised to breastfeed without effective counselling on risks, the ethics of policies that argue for or against breastfeeding and the rights of women to choose an infant feeding practice need examination.…”

Section: Exposure To Antiretroviral Drugs Through Breastfeedingmentioning

confidence: 99%

Transmission of CMV, HTLV-1, and HIV through breastmilk

Prendergast

Goga

Waitt

et al. 2019

The Lancet Child & Adolescent Health

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Breastfeeding is a critical child survival intervention. The potential for transmission of some viral infections from mother-to-child, however, presents the dilemma of how best to interpret the benefits and risks of breastfeeding in different settings. Here, we compare the transmission dynamics, risk factors and outcomes of infection with three chronic viruses transmitted through breast milk: cytomegalovirus (CMV), human T-cell lymphotropic virus type 1 (HTLV-1), and human immunodeficiency virus (HIV). We provide an overview of current intervention approaches and discuss scientific, policy and programming gaps in our understanding of these major global infections. Key messages: • Three viruses are known to be transmitted through breastfeeding and to result in chronic infection: CMV, HTLV-1 and HIV. • CMV transmission through breast milk mostly leads to subclinical infection, except in preterm infants in whom severe clinical disease can occur; the best preventive and treatment approaches in this group remain unclear and more data are needed on long-term sequelae. • HTLV-1 is restricted to specific geographic foci and can be transmitted from mother-to-child through breastfeeding in 10-25% of cases; the best preventive strategy is avoidance or shortening of breastfeeding where safe alternatives are available. • The absolute transmission risk of HIV through breastfeeding in the context of suppressive maternal antiretroviral therapy is now low, even over extended periods. • Guidance for infant feeding for women living with HIV varies by setting: in low-and middle-income countries, breastfeeding with suppressive ART and adherence support is recommended, while in high-income settings formula feeding is advised.

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Section: Exposure To Antiretroviral Drugs Through Breastfeedingmentioning

confidence: 99%

Transmission of CMV, HTLV-1, and HIV through breastmilk

Prendergast

Goga

Waitt

et al. 2019

The Lancet Child & Adolescent Health

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“…There is evidence that the under-reporting noted for ADRs in national spontaneous reporting schemes is as true for children and neonates [35,36] as for adults. As we have seen, knowledge of the potential for nephrotoxicity with aminoglycosides, and an understanding of their pharmacokinetics, has resulted in steps to optimize the dosage.…”

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Solving the problem of dose optimization of children’s medicines

McWilliam

Hawcutt

2018

Expert Review of Clinical Pharmacology

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“…1 The rate of under-report-ing of ADRs has been estimated to be approximately 94% and neonatal ADR reports are not influencing the clinical warnings issued by the MHRA. 2,3 This study aims to compare reports of neonatal ADRs actively collected by a researcher from a tertiary neonatal unit to those reported to the UK yellow card system between 2001 and 2010. Methods An independent researcher collected data on ADRs in a tertiary neonatal care unit by daily ward round attendance, note reviewing and staff questioning.…”

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confidence: 99%

“…The results collected over four weeks were then compared to the yellow cards submitted to the MHRA between 2001 and 2010 by means of reviewing a recently published paper. 3 Results Between 2001 and 2010 there were ninety seven yellow card reports of neonatal ADRs to the MHRA. Over a four week observational period thirty three neonatal ADR cases were suspected and reported by a researcher.…”

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confidence: 99%

“…EVALUATION OF RHIGF-1/RHIGFBP-3 TO ESTABLISH AND MAINTAIN PHYSIOLOGICAL INTRAUTERINE SERUM IGF-1 LEVELS EARLY AFTER BIRTH IN EXTREMELY PRETERM INFANTSTurner*, 2 Hallberg,3 Ingrid, 4 Hellström,3 Ley, 5 Mangili, 5 Tocoian, 5 Barton, 5 Chung.University of Liverpool, LIVERPOOL, UK; 2 Department of Neonatology, CLINTEC, Karolinska Institutet/University Hospital, STOCKHOLM, Sweden; 3 Lund University, Skåne University Hospital, Institute of Clinical Sciences Lund, LUND, Sweden; 4 Institute of Neuroscience and Physiology, Sahlgrenska Academy, GOTHENBURG, Sweden; 5 Shire, LEXINGTON, MA, USA 10.1136/archdischild-2017-esdppp.63…”

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PP-36 Therapeutic indications for use of extemporaneous glucocorticoid formulations in children – the glufic study

et al. 2017

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BackgroundThe majority of young children with wheezing have transient symptoms typically associated with viral upper respiratory tract infections and do not have increased risks of asthma later in life. Episodes with severe respiratory symptoms are reported in these chil-dren too. How to diagnose these patients makes clear ev-idence based treatment guidelines unfeasible. Children aged 0–5 years with wheezing may be symptomatically treated with inhaled short-acting beta-2-adrenergic-ago-nist therapy. If no relief of symptoms or severe symptoms, treatment guidelines recommend oral or systemic gluco-corticoids. Since no exact therapeutic interval exists for oral glucocorticoids, there is inconsistency on the dosing recommendations. Moreover, currently the only licensed glucocorticoid preparations in Denmark are tablets or i.v. formulations. These formulations are not suitable, since young children are unable to swallow tablets, and i.v. ad-ministration is associated with unnecessary discomfort. In consequence, children younger than 5 years are treated with extemporaneous preparations, off-label, or unli-censed medications. Use of extemporaneous formula-tions prelude several drawbacks e.g. formulation diversity, differences in bioavailability, limited shelf-live, safety-pro-file, taste etc. Despite the wide therapeutic index of glu-cocorticoids, it is important that they are administrated at the lowest effective dose as a considerable number of dose dependent adverse events exist for these drugs.ObjectiveTo describe the use of extemporaneous glu-cocorticoids in children≤5 years of age diagnosed with acute symptoms of asthmatic bronchitis, compared to existing guidelines across three regional paediatric depart-ments. Second, to examine if high or low dose glucocor-ticoid influences the length of hospitalisation.MethodsA descriptive, chart-based study including three paediatric departments in the Capital Region of Denmark. All patients 0–5 years of age diagnosed with acute symptoms of asthmatic bronchitis in 2013–2015 were eligible for inclusion at the day they received at least one extemporaneously prepared administration of pred-nisolone.ResultsDuring the three-year period almost 560 ad-missions were included, of which 70% were boys. The average age was 22,3 months±13,3, and the average weight 12,2 kg ±2,9. A priori, the paediatric wards used dif-ferent dosing regimens, which were reflected in the data, primarily varying from 1 mg/kg to 2 mg/kg for the first dose administrated. The patients received eight different kinds of extemporaneous formulations, with no obvious pattern of choice. For statistical analyses COX-regression were used. No coherence between dosing and length of hospitalisation were found.ConclusionThis survey shows that the paediatric depart-ments used a variety of extemporaneous liquid prednis-olone formulations interchangeably. The degree of in-consistency raises issues concerning optimal dosing and potential toxicity. Since no association between higher doses and shorter length of hospitalisation w...

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Spontaneous adverse drug reaction reports for neonates and infants in the UK 2001–2010: content and utility analysis

Cited by 19 publications

References 42 publications

Transmission of CMV, HTLV-1, and HIV through breastmilk

Transmission of CMV, HTLV-1, and HIV through breastmilk

Solving the problem of dose optimization of children’s medicines

PP-36 Therapeutic indications for use of extemporaneous glucocorticoid formulations in children – the glufic study

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