European Journal of Clinical Pharmacology

, Volume 74, Issue 11, pp 1471–1474 | Cite as

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

  • Alfredo J. Rodrigues-Neto
  • Camila Biazoni-Albaricci
  • Adalton Ribeiro
  • Silvana Lima
  • Albert FiguerasEmail author
Pharmacoepidemiology and Prescription



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.


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.


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.


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.


Pharmacovigilance Medicines utilisation Off-label Somatropin 


Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

228_2018_2510_MOESM1_ESM.docx (18 kb)
ESM 1 (DOCX 18 kb)


  1. 1.
    Ayyar VS (2011) History of growth hormone therapy. Indian J Endocrinol Metabol 15:162. CrossRefGoogle Scholar
  2. 2.
    Conrad P, Potter D (2004) Human growth hormone and the temptations of biomedical enhancement. Sociol Health Illn 26:184–215CrossRefGoogle Scholar
  3. 3.
    Gasco V, Caputo M, Lanfranco F, Ghigo E, Grottoli S (2017) Management of GH treatment in adult GH deficiency. Best Pract Res Clin Endocrinol Metab 31:13–24CrossRefGoogle Scholar
  4. 4.
    Samaras N, Papadopoulo MA, Samaras D, Ongaro F (2014) Off-label use of hormones as an antiaging strategy: a review. Clin Interv Aging 9:1175–1186CrossRefGoogle Scholar
  5. 5.
    von Haeling S, Ebner N, dos Santos MR, Springer J, Anker SD (2017) Muscle wasting and cachexia in heart failure: mechanisms and therapies. Nat Rev Cardiol 14:323–341. CrossRefGoogle Scholar
  6. 6.
    Tritos NA (2017) Focus on growth hormone deficiency and bone in adults. Best Pract Res Clin Endocrinol Metab 31:49–57CrossRefGoogle Scholar
  7. 7.
    Agência Nacional De Vigilância Sanitária - Anvisa (2004) Available at: Accessed 19 June 2017
  8. 8.
  9. 9.
    Food and Drug Administration (FDA). Somatropin information. Available at: Accessed 24 May 2018
  10. 10.
    Bartke A (2003) Can growth hormone (GH) accelerate aging? Evidence from GH-transgenic mice. Neuroendocrinology 78:210–216CrossRefGoogle Scholar
  11. 11.
    Brazilian Health Ministry (2010) Portaria N° 110, de 10 de Março de 2010. Protocolo Clínico e Diretrizes Terapêuticas–Hipopituitarismo. Available at: Accessed 23 May 2018)
  12. 12.
    Barake M, Klibanski A, Tritos NA (2014) Effects of recombinant human growth hormone therapy on bone mineral density in adults with growth hormone deficiency: a meta-analysis. J Clin Endocrinol Metab 99:852–860CrossRefGoogle Scholar
  13. 13.
    Anonymous (2016) Grupo desviou R$ 1,6 mi em remédio vendido como ‘bomba’, diz polícia. Available at: Accessed 23 May 2018
  14. 14.
    Anonymous (2017) Polícia flagra casal suspeito de desviar remédios de hospital estadual. Available at: Accessed 23 May 2018

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Faculdade de Ciências FarmacêuticasUniversidade de São PauloSão PauloBrazil
  2. 2.Núcleo de Farmacovigilância, Centro de Vigilância Sanitária de São PauloSão PauloBrazil
  3. 3.Fundació Institut Català de Farmacologia, Departament de FarmacologiaUniversitat Autònoma de BarcelonaBarcelonaSpain
  4. 4.Fundació Institut Català de FarmacologiaHospital Vall d’HebronBarcelonaSpain

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