O uso não descrito em bula (off label) de medicamentos anti-histamínicos na pediatria

Abstract

Pediatricians need to be more sensitive to a holistic view of children and adolescents, within the social context in which they live, and to the safety and efficacy of prescribed medicines, which depends on the concentrations of the drug in the body.

With regard to pediatric formulations, the main factors that discourage the pharmaceutical industry from developing drugs for children include: the small number of subjects available to take part in these studies, the high marginal costs, the small market and the ethical complexity of these studies. In this sense, doctors practice off-label use, which can be defined as the use of a drug that has not been approved by the local health authority.

Due to their sedative effect, H1 antihistamines lead the way in off-label prescriptions in pediatrics. The reasons for their use are diverse, but we can highlight: inducing sleep, treating flu and cough, rhinitis, dermatitis, asthma, otitis and urticaria. Since many drugs used to treat allergic diseases have not been studied in pediatric populations, due to certain ethical barriers, off-label prescribing of these products is common and generates concern about possible adverse events, even with the growing concern and efforts to improve healthcare for children, specifically through the use of safe and effective drugs.

Thus, in the post-marketing period of a pharmaceutical product, pharmaceutical professionals within pharmacovigilance, as Drug Registration Holders (DRM), monitor safety information and, based on this, carry out benefit-risk assessments and establish risk minimization measures, in addition to the pharmacist's duty and ethical commitment to instruct children's parents and guardians even when the use of medicines is off-label.