Antibiotic-related adverse events in paediatrics: unique characteristics

ABSTRACT

Introduction: Antibiotics have saved and are still saving countless human lives from the burden of infectious diseases. However, as with all other drugs, they can cause adverse events. Generally, these are uncommon, mild and spontaneously resolving. However, in some cases, they can cause relevant clinical problems. Compared with adults, children, particularly in the first years of life, have a higher risk of antibiotic-related adverse events for several reasons.

Areas covered: In this paper, the conditions that can contribute to the elevated risk of antibiotic-related adverse events in children are discussed.

Expert opinion: Antibiotic stewardship can be a solution to limit antibiotic abuse and misuse and consequently the incidence of antibiotic-related adverse events in children. Moreover, most of the antibiotic-associated adverse events can be avoided with more extensive pre-marketing medicine investigations, improved postmarket safety surveillance system, increased transparency throughout the clinical research enterprise, increased training of clinical pharmacologists and paediatric researchers, expanded pool of paediatric patients, and providing additional funding and incentives for paediatric drug development.

KEYWORDS:

• Adverse event
• antibiotic stewardship
• antibiotics
• drug development
• drug safety

Article highlights

• Since their discovery, antibiotics have been considered one of the most important medical advances.

• Compared with adults, children, particularly in the first years of life, have a higher risk of antibiotic-related adverse events.

• Stewardship programmes can reduce antibiotic abuse and misuse in the pediatric population and limit related adverse events.

• Protocols and guidelines, if not shared with other health care workers who can contribute to the rationalization of prescriptions, can be seen as a measure interfering with paediatrician routine practice, leading it to be questioned.

• Most of the drugs that are licensed for adults and that could also be useful for children are not sufficiently developed because the pharmaceutical industry does not adequately consider the use of the drug in paediatricsThis box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was funded by the Pediatric Section, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Perugia (PED-2019-04).