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Many agents prescribed for allergic disease not tested in children

Many agents prescribed for allergic disease in children are done so on an off-label or unlicensed basis, according to recent results.

“Global legislation and regulatory efforts have been done to overpass these limitations aiming to produce proper research in the pediatric population, promoted by an International Conference on Harmonization (ICH) guidelines for clinical investigation of medicinal products in the pediatric population,” Diana Silva, MD, of the immunoallergy department at Centro Hospitalar de São João, in Portugal, and colleagues wrote.

To determine the trends in off-label use in children, particularly in respiratory and allergic diseases, the researchers conducted a systematic search of PubMed/Medline in July 2013 using the terms: off-label, unlicensed, unapproved, and unregistered, or children. They found that the percentage of off-label use varied from 3% to 51% of prescriptions, and reached a prevalence of 78% when they considered patients who were administered at least one off-label medication.

Diana Silva

“This variability can be explained by the different settings (countries), age range and population sample (outpatient, inpatient, population databases from pharmacies or from medical prescription records),” the researchers wrote.

And, while it is often necessary to use medication in an off-label basis, the investigators said clinicians should follow indications, therapeutic alternatives and risk-benefit analyses, along with collecting the informed consent of the patient or guardian.

“There is a need for new studies with a better design to access long-term safety and efficacy of respiratory and allergy on-market drugs in children, primarily in those under 2 years of age,” they wrote. “New ways should be found by the competent authorities to promote more research accordingly to the patients’ needs, namely on the respiratory and allergy fields.”

Disclosure: The researchers report no relevant financial disclosures.