Citation

Conte C, Rousseau V, Vert C, Montastruc F, Montastruc JL, Durrieu G, Olivier P. Fundam. Clin. Pharmacol. 2020; ePub(ePub): ePub.

Affiliation

Service de Pharmacologie Médicale et Clinique, Centre de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, CHU, Toulouse, F-31000, France.

Copyright

(Copyright © 2020, John Wiley and Sons)

DOI

10.1111/fcp.12542

PMID

32022302

Abstract

In adults, statins safety profile is well known. However, literature data on their adverse drug reactions (ADRs) remain scarce in children in real life setting. In order to better characterize ADRs related to "real-life" use of statins in children, we reviewed statin-related ADRs recorded in the World Health Organization (WHO) global database of individual case safety reports (ICSRs), VigiBase Methods. Individual case safety reports (ICSRs) in children (2-11 years) and adolescents (12-17 years) associated to statins from January 1, 1987 to July 18, 2017 were extracted from VigiBase. Characteristics of ICSRs, type of ADRs according to MedDRA classification (SOC and PT) and ICSR seriousness were described using SAS 9.4. A total of 311 ICSRs were identified for 8 statins with 712 ADRs. Musculoskeletal disorders (n=85, 27.3%) were the first registered ADRs followed by general disorders (n=67, 21.5%; mainly asthenia and pain). More than 1 out of 5 ADRs were "injury, poisoning and procedural complications" (n=67), mainly accidental or intentional exposures (n=44, 14.1%), overdoses (n=14, 4.5%) or off label use (n=11, 3.5%). Overall, 133 (42.8%) reports were "serious", including 11 deaths. Deaths mainly involved adolescents with intentional overdose and completed suicide with other associated drugs in 75% of reports. Our study identified rare but serious safety issues (rhabdomyolysis, myalgia, hepatocellular injury). These ADRs can impact quality of life or lead to life-threatening complications in children. Our results should be supplemented with other data sources. Spontaneous statin ADR reports in children to pharmacovigilance networks must be promoted.

© 2020 Société Française de Pharmacologie et de Thérapeutique.

Language: en