Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System.

ABSTRACT:

Background

Among factors influencing the higher risk of developing unknown or rare adverse drug reactions (ADRs) among children and adolescents, there is the frequent off-label use of drugs that seems to be very common in pediatric oncological patients. Our study aim to collect and evaluate data on the safety profile of antineoplastic drugs and their off-label use in the pediatrics population using real life data.

Methods

We retrieved Individual Case Safety Reports (ICSRs) with an anticancer agent as suspected drug among those reported through the Campania spontaneous reporting system from 1 January 2013 to 30 September 2019. We classified ICSRs into four off-label categories: "age," "route of administration," "weight," and "therapeutic indication." We defined an ICSR as an

SUBMITTER: Mascolo A 

PROVIDER: S-EPMC7221123 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature