Adverse Reactions to Drugs of Special Interest in a Pediatric Oncohematology Service

Amaro-Hosey, Kristopher; Danés, Imma; Vendrell, Lourdes; Alonso, Laura; Renedo, Berta; Gros, Luis; Vidal, Xavier; Cereza, Glòria; Agustí, Antònia

doi:10.3389/fphar.2021.670945

Cited by 4 publications

(2 citation statements)

References 34 publications

(37 reference statements)

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“…Mascolo ( 11 ) analyzed the safety profiles of antineoplastic drugs in Italy and described the off-label use in pediatric patients. Amaro-Hosey ( 12 ) assessed the incidence and characteristics of ADRs in a pediatric oncohematological population in Spain. Research on intervention measures in pediatric cancer patients still has gaps.…”

Section: Introductionmentioning

confidence: 99%

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database

et al. 2021

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IntroductionAdverse drug reactions (ADRs) in pediatric cancer patients have not yet received due attention in the world. Antineoplastic drugs are frequently related to ADRs. Few studies focus on the ADR and the intervention measures in pediatric cancer patients.MethodsADR reports submitted to Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to gender, age, disease types, past history of ADR, occurrence time of ADR, polypharmacy, route of administration, off-label drug use, name of suspected drugs per ADR report, and severity of ADR reports.ResultsA total of 431 ADR reports related to antineoplastic drugs in pediatric patients were collected, 31.55% were serious ADRs (SADRs). The median age of patients was six years (inter quartile range, IQR: 3-11), the age groups with higher reporting rates were concentrated in 1-3-year-olds (130). Past history of ADR, occurrence time of ADR and polypharmacy were statistically associated with SADR. Myelosuppression was the most frequent ADR (15.55%), cytarabine was the most frequent drug (26.22%). The signal mining method produced 14 signals, three signals were off-label ADRs.ConclusionsThis study described the characteristics of ADRs in pediatric cancer patients. By conducting signal mining method, three off-label ADRs need further study. We should pay more attention to these ADRs and develop relative management strategies. More researches are needed to achieve a better understanding of the characteristics of ADRs in pediatric cancer patients of China.

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Section: Introductionmentioning

confidence: 99%

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database

et al. 2021

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“…No studies with novel drugs such as monoclonal antibodies or tyrosine kinase inhibitors were found up to 2020. A recently published study (Amaro-Hosey et al, 2021) prospectively assessed drug safety with some specific therapies, including novel drugs and conventional chemotherapy. The most frequent ADR were hematological, infections and gastrointestinal.…”

Section: Schumock and Thorntonmentioning

confidence: 99%

Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review

2022

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Introduction: Adverse drug reactions (ADR) are an important cause of morbidity and mortality in pediatric patients. Due to the disease severity and chemotherapy safety profile, oncologic patients are at higher risk of ADR. However, there is little evidence on pharmacovigilance studies evaluating drug safety in this specific population.Methods: In order to assess the incidence and characteristics of ADR in pediatric patients with oncohematogical diseases and the methodology used in the studies, a systematic review was carried out using both free search and a combination of MeSH terms. Data extraction and critical appraisal were performed independently using a predefined form.Results: Fourteen studies were included, of which eight were prospective and half focused in inpatients. Sample size and study duration varied widely. Different methods of ADR identification were detected, used alone or combined. Causality and severity were assessed frequently, whereas preventability was lacking in most studies. ADR incidence varied between 14.4 and 67% in inpatients, and 19.6–68.1% in admissions, mainly in the form of hematological, gastrointestinal and skin toxicity. Between 11 and 16.4% ADR were considered severe, and preventability ranged from 0 to 74.5%.Conclusion: ADR in oncohematology pediatric patients are frequent. A high variability in study design and results has been found. The use of methodological standards and preventability assessment should be reinforced in order to allow results comparison between studies and centers, and to detected areas of improvement.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=96513, identifier CRD42018096513.

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Clinical pharmacology facing the real-world setting: Pharmacovigilance, pharmacoepidemiology and the economic evaluation of drugs

Agustí,

Cereza,

de Abajo

et al. 2023

Pharmacological Research

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Adverse Reactions to Drugs of Special Interest in a Pediatric Oncohematology Service

Cited by 4 publications

References 34 publications

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database

Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database

Adverse Drug Reactions in Pediatric Oncohematology: A Systematic Review

Clinical pharmacology facing the real-world setting: Pharmacovigilance, pharmacoepidemiology and the economic evaluation of drugs

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