ArticleInternational journal of clinical pharmacy2013
Evaluation of unlicensed and off-label antiepileptic drugs prescribed to children: Brazilian Regulatory Agency versus FDA.
Article in International journal of clinical pharmacy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 18 citations in OpenAlex.
- A comparison of the labeling of antineoplastic and supportive medicines in China, Japan, and the US based on the WHO essential medicines list.Frontiers in medicine · 2025Article
- Suitability of paediatric legislation beyond the USA and Europe: a qualitative study on access to paediatric medicines.BMJ public health · 2024Article
- Anti-seizure Medication Prescription in Adult Outpatients With Epilepsy in China, 2013-2018.Frontiers in neurology · 2021Article
- Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study.BMC pediatrics · 2016Article
- Retapamulin prescriptions and monitored off-label use.Paediatric drugs · 2014Article
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Authors and funding
3 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEpileptic seizures are neurological disorders common in children; 4 to 10% of under 16-year olds have suffered at least one seizure. Antiepileptic drugs represent the basis of treatment for the majority of patients, but many of the drugs prescribed to pediatrics are used unlicensed and off-label.
objectiveTo analyze the prevalence of use of unlicensed and off-label antiepileptic drugs, by the pediatric population, according to the Food and Drug Administration and the Brazilian National Health Surveillance Agency. Setting General Hospital of the Faculty of Medicine at Ribeirão Preto, Brazil.
methodsA cross-sectional, retrospective and observational study was carried out. The daily prescriptions of children up to 12 years of age were collected for the analysis of antiepileptic drug use. Data of the registration number, sex, age, reason hospitalized, unit where hospitalized, drug prescribed, dosage, route and administration frequency were collected.
main outcome measureAntiepileptic drugs prescribed for children were classified as unlicensed and off-label according to the term of the product's license registered in the Food and Drug Administration and the Brazilian National Health Surveillance Agency.
resultsOf the 6,637 pediatric patients identified during the study period, 583 (9.0%) received at least one antiepileptic drug. The most used antiepileptic drugs were phenobarbital, phenytoin, carbamazepine, valproic acid and clonazepam. As expected, the number of pharmaceutical dosage form classified as unlicensed or off-label was high in both agencies, but distinct between the two. The number of patients (n = 287) using unlicensed drugs was similar in the two agencies, but the use of off-label drugs was higher according to the analysis carried out by the North American agency (40.5%).
conclusionsOld-generation antiepileptic drugs are widely prescribed to children. The results found for the use of off-label drugs demonstrate the absence of uniformity in action between the agencies and a lack of integration between the studies carried out. Although legislation on the licensing of drugs aims to protect the patients from drugs that have not been scientifically evaluated, the scarcity of data about the safety of the therapeutic resources obliges the doctors to prescribe unlicensed and off-label antiepileptic drugs to the pediatric population.
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