Adverse drug reactions in childhood: a review of prospective studies and safety alerts

Clavenna, Antonio; Bonati, Maurizio

doi:10.1136/adc.2008.154377

Cited by 148 publications

(139 citation statements)

References 41 publications

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“…8 In 25 As concluded in the review from Mason et al, 28 it seems that there is no consistent evidence suggesting a greater risk related to off-label prescribing, perhaps because of the heterogeneity in prescribing settings or practices considered in the studies. Indeed, some studies found high rates of off-label prescribing of mental health or cancer medications.…”

Section: Studies Investigating Adr Occurrence In Outpatient Settingsmentioning

confidence: 96%

“…As a result of these initiatives, it may be hypothesized that prescribers would be more aware of the potential consequences of off-label prescribing, decreasing the prevalence of off-label prescribing and associated risks. 8 A study 2 performed in the early 2000s in France showed that off-label prescribing was highly prevalent (42%) and significantly associated with ADR occurrence. Since this period, in line with the promotion of drug evaluation and the development of new pediatric formulations, the situation is likely to have evolved.…”

Section: What This Study Addsmentioning

confidence: 99%

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Off-Label Prescribing in Pediatric Outpatients

Palmaro

Bissuel²,

Renaud

et al. 2015

Pediatrics

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To study the characteristics of off-label prescribing and adverse drug reaction (ADR) occurrence in a sample of pediatric outpatients treated by general practitioners.METHODS: A survey on pediatric drug prescribing was implemented in 46 general practices in southwestern France. All consecutive patients aged 0 to 16 years were included. Patient characteristics, reasons for consultation, and drug prescribed (including indications) were collected. ADRs occurring #10 days after the date of consultation were recorded by the general practitioners (spontaneous notification). Off-label prescription was defined as prescribing outside the specifications of the Summary of Product Characteristics.RESULTS: Among the 2313 children seen between March 8, 2011 and July 31, 2011, 1960 were exposed to $1 prescribed drug. Mean age was 5.6 years, with a gender ratio of 1.1. Among children with prescriptions, 37.6% (n = 736) were exposed to $1 off-label prescription and 6.7% (n = 132) to $1 unlicensed drug. Off-label prescribing involved an unapproved indication in 56.4% of cases (n = 416), a lower dosage (26.5%, n = 195) or higher dosage (19.5%, n = 144) than specified, age not labeled (7.2%, n = 53), incorrect route of administration (3.5%, n = 26), and contraindication (0.3%, n = 2). A total of 23 ADRs were reported (1.5% of patients with off-label prescriptions). ADR occurrence was not significantly related to off-label drug prescribing.CONCLUSIONS: Despite the numerous initiatives implemented for promoting rational medicine use in children, the prevalence of off-label prescription in outpatient pediatric practice remains high.

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Section: Studies Investigating Adr Occurrence In Outpatient Settingsmentioning

confidence: 96%

Section: What This Study Addsmentioning

confidence: 99%

Off-Label Prescribing in Pediatric Outpatients

Palmaro

Bissuel²,

Renaud

et al. 2015

Pediatrics

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“…One in ten children in hospital in a high income country (HIC) will experience an ADR [2]. A study in Cuba suggested that at least one in 500 children will experience an ADR each year [3].…”

Section: Introductionmentioning

confidence: 99%

Systematic review of paediatric studies of adverse drug reactions from pharmacovigilance databases

Cliff-Eribo

Sammons

Choonara

2016

Expert Opinion on Drug Safety

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ObjectiveTo perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases. MethodsA systematic literature search of studies describing results for paediatric ADRs from national pharmacovigilance databases was performed. PubMed database, Embase and MEDLINE were searched up to March 2015. The descriptive studies included were analysed for country of origin, reporters, and ADR reporting rate, drugs, ADRs and number of fatalities. Results20 studies were identified. Doctors were the largest group of reporters in all the studies, and with more consumer reports seen in USA. The studies ranged from 3 -37 years. The highest ADR reporting rate was 1458 reports per year per million children in Cuba. Antibiotics and vaccines were the most frequently reported drugs, in almost all the studies. The most frequent ADRs were skin and nervous system disorders. The highest proportion of fatalities and serious reports was from North America.Drugs used for treating attention deficit hyperactivity disorders (ADHD) and isotretinoin were the most frequently reported drugs for ADRs in North America. ConclusionsThere were geographical differences in drugs responsible for ADRs and their seriousness, especially in North America. Very few studies were conducted in Asia and Latin America, none were found from Africa.2

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“…Steroids have been prescribed only in cases of acute laryngotracheobronchitis (reduces laryngeal edema) and lobar pneumonia (ineffective). [23] It should be mentioned that the ADRs seen in our study were caused by antibacterials, as was also seen in Spain, [24] Brazil, [25] and Italy, [26] thus substantiating the widely acknowledged fact that irrational use of antibacterials led to adverse drug reactions. A disturbing fact noted was that all ADRs were preventable in nature (two defi nitely WHO=World health organization, EML=Essential medicines list and one probably), as either the causal drugs were not indicated in the patients or preventive measures could have been taken.…”

Section: Discussionmentioning

confidence: 67%