Identification of suspected fatal adverse drug reactions by paediatricians: a UK surveillance study

Cheng, K; Masters, Samuel H.; Stephenson, Terence; Ferner, Robin E; Ashworth, MT; Nunn, AJ

doi:10.1136/adc.2006.107789

Cited by 16 publications

(9 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Third, it is important to discuss suspected drugs. As underlined above, previous studies found variable results according to the studied populations and used methodologies; however, anticonvulsants, ADHD, antiacne, respiratory, anti‐infectious, cytotoxic and anaesthetic drugs were among the first suspect drugs found in previous studies 6–11 . Our study updates these previous works applying them to the last decade (2010–2019) and finds that the main suspect drugs were, beside vaccines, central nervous system drugs with, first, the antiepileptic vigabatrin, which is associated mostly with deaths from respiratory origin.…”

Section: Discussionsupporting

confidence: 72%

“…In 2002, Clarkson reported that, among 331 deaths with 390 suspected drugs reported through the Yellow Card Scheme from 1964 to 2000 in England in children aged 16 years or less, drugs most frequently mentioned were anticonvulsants (65 deaths, with sodium valproate involved in 31 deaths), cytotoxics (34 deaths), anaesthetics (30 deaths) and antibiotics (29 deaths) 6 . Cheng et al 7 found that only 2 out of the approximately 2000 cards received by the British Paediatric Surveillance Unit could be causally related to the index drug and discussed importance of underreporting. Johann‐Liang's group used the Food and Drug Administration’s adverse event reporting system and found that proportion of serious ADRs reported in children was similar to adults and that drug reported classes noted in paediatric age groups were different from those found in adults with anticonvulsants, attention deficit hyperactivity disorder (ADHD), antiacne and respiratory drugs 8 .…”

Section: Discussionmentioning

confidence: 99%

“…In contrast to the large number of publications describing fatal ADRs in adults, 1–4 there are relatively few data in children 6–11 and little information with the most recently marketed and used drugs at the beginning of the 21st century. Children are particularly at risk of ADRs due to their metabolic and physiological immaturity.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Fatal adverse drug reactions in children: A descriptive study in the World Health Organization pharmacovigilance database, 2010–2019

Montastruc¹

2022

Brit J Clinical Pharma

View full text Add to dashboard Cite

Aims Adverse drug reactions (ADRs) represent a significant public health burden. There are few data on fatal ADRs in children. This population is particularly at risk due to metabolic and physiological immaturity, frequent off‐label drug use and limited paediatric clinical pharmacology studies. The study investigated the main characteristics of drug‐related deaths registered in World Health Organization pharmacovigilance database, during the past decade. Methods Fatal outcomes registered between 2010 and 2019 in children (<18 y) and reported by physicians were investigated. Age, sex and suspected drugs were described and disproportionality analyses investigated differences according to sex, age and continents with calculation of reporting odds ratio and its 95% confidence interval. Results Among the 1 198 560 reports registered in children, 1585 (0.13%) were fatal. They occurred mainly in boys, aged 28 days–23 months. Reports mostly came from the Americas and Europe and involved, besides anti‐infectious drugs (mainly vaccines), central nervous system (vigabatrin, paracetamol, methylphenidate…) and antineoplastic/immunomodulating (mainly thalidomide) and cardiovascular (mainly bosentan) drugs without major differences between boys and girls. Large differences were found according to continents and age. The risk of reporting was higher in boys, in children aged <23 months, in the Americas and Africa. Conclusion Fatal ADRs represented a small part (around 1/1000) of total registered ADRs, occurred more frequently in boys and during the first 2 years of life. Beside anti‐infectious drugs (vaccines), neuropsychiatric drugs were the most frequently involved, with large differences according to continents and classes of age.

show abstract

Section: Discussionsupporting

confidence: 72%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Fatal adverse drug reactions in children: A descriptive study in the World Health Organization pharmacovigilance database, 2010–2019

Montastruc¹

2022

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…Data from the British Paediatric Surveillance Unit found four infant deaths associated with ADRs in a single year (2002–3) , while equivalent ADRs (where the child received the medication postnatally) in this cohort are reported with a mean frequency of 3.7 per year, suggesting that clinicians are reporting these most serious of suspected ADRs to the YC Scheme.…”

Section: Discussionmentioning

confidence: 79%

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

Hawcutt

Russell

Maqsood

et al. 2016

Brit J Clinical Pharma

View full text Add to dashboard Cite

AIMSThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years. METHODSData on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA. RESULTSFor infants age <2 years, 3496 suspected ADRs were reported using YC (paternal medication pre-conception n = 3, transplacental n = 246, transmammary n = 30, neonates n = 97, infant n = 477, and vaccinations n = 2673), averaging 0.96 YC per day. There was a male preponderance (male 49.1%, female 44.4%, unknown 6.5%), and only 34 (1.0%) of YC reports stated a gestational age. The medications most frequently reported were: transplacental and transmammary (fluoxetine, n = 21 and n = 4 respectively), neonate (swine flu vaccine, n = 8) infant (oseltamivir, n = 37) and vaccines (meningococcal vaccine, n = 693). Paternal, transmammary, neonatal and infant YC did not reflect clinical concerns raised by the UK regulator. Transplacental and vaccination reports did correlate with some of the changes in practice and clinical alerts received. CONCLUSIONSThe frequency of YC reports for those <2 years is low, neonates are poorly represented, and recording of gestational age is poor. With the exception of vaccinations, spontaneous reports alone are not currently generating the data required, and important safety messages from the regulator do not match reporting patterns. Additional reporting strategies are required to improve the quantity and quality of suspected ADR data in young children.

show abstract

“…In 2004 a national study of severe and fatal ADRs identified only 18 cases within a year 5. Underascertainment was suspected due to: (1) difficulty in identifying whether a reaction was an ADR or part of the underlying disease process, (2) difficulty in identifying an individual drug among multiple drugs prescribed and (3) a reluctance to report such cases, particularly when the medicines had been used unlicensed or off label.…”

Section: Introductionmentioning

confidence: 99%

The use of electronic reporting to aid surveillance of adverse drug reactions (ADRs) in children: a proof of concept study

Lynn

Riding

McIntosh

2010

Archives of Disease in Childhood

View full text Add to dashboard Cite

Objective To investigate: (1) the feasibility of establishing active paediatric surveillance for adverse drug reactions (ADRs), (2) whether electronic reporting is effective and (3) whether such a system could complement the Medicines and Healthcare products Regulatory Agency (MHRA) yellow card system. Design Between January 2006 and February 2007 ADRs in children under 16 were reported each month by consultant paediatricians and paediatric pharmacists in Scotland. For 8 months respondents received a postal card, after which half were selected to report electronically via an email card for a further 6 months and half continued with the postal card. Reports of paediatric ADRs severe enough to warrant hospital admission or to delay discharge of hospitalised patients or resulting from an outpatient prescription were followed up. A postal questionnaire evaluated the system at the end of the study. Results Following a 2-month lead-in period, 83% of the cards were returned over the year, 84% by paediatricians and 82% by pharmacists. With electronic reporting the response rate was 80%. Eighty-seven confi rmed reports of a drug being associated with one or more adverse reactions were reported in 67 children. Only eight children were also identifi ed through the MHRA yellow card system. Respondents indicated continuing willingness to contribute to an active (preferably electronic) reporting system. Conclusions Active paediatric ADR surveillance is feasible; electronic reporting is effective and data collected are different to, but could complement, those collected by the MHRA yellow card.

show abstract

Identification of suspected fatal adverse drug reactions by paediatricians: a UK surveillance study

Cited by 16 publications

References 14 publications

Fatal adverse drug reactions in children: A descriptive study in the World Health Organization pharmacovigilance database, 2010–2019

Fatal adverse drug reactions in children: A descriptive study in the World Health Organization pharmacovigilance database, 2010–2019

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

The use of electronic reporting to aid surveillance of adverse drug reactions (ADRs) in children: a proof of concept study

Contact Info

Product

Resources

About