Towards preventive pharmacovigilance through medicine misuse identification: an example with recombinant human growth hormone for aesthetic purposes

Abstract

Purpose: Historically, somatropin has been used for conditions related with ageing, but since the marketing of recombinant human growth hormone (rhGH), increasing promotional pressure has prompted aesthetic uses, despite lack of evidences about its efficacy and safety for those purposes. Methods: A routine analysis of the Pharmacovigilance Center of São Paulo (Brazil) showed reports of suspected adverse reactions in young adults and mature patients receiving rhGH. After presuming an off-label use of this expensive product, a drug utilisation study within the pharmacovigilance database has been carried out. Results: The analysis showed a bimodal age distribution of the rhGH reports. Up to 17.1% of the 1289 reports (n = 220) involved patients aged ≥ 20 years taking rhGH for off-label uses. Conclusions: This information was the basis to design interventions in order to reduce inappropriate utilisation of this expensive product. Analyses of how medicines are being used through pharmacovigilance databases are a way to identify its irrational utilisation, thus facilitating preventive actions to improve how medicines are used and reducing avoidable adverse effects.