A case of medicine in disguise: motion sickness patches sold as medical devices containing active pharmaceutical substances

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Abstract

Introduction. A case study is reported on anti-motion sickness transdermal patches sold in the Internet, claiming to contain only natural ingredients but, actually, containing The visual inspection of the samples evidenced many inconsistencies in secondary and primary packaging, missing of various legal information and a non-compliant “CE” mark.
Methods. The qualitative analysis was performed by liquid chromatography - high resolution mass spectrometry and the quantitative by liquid chromatography with diode array detector.
Results. The analyses evidenced the presence of the antihistaminic drug Diphenhydramine and of other active substances (Capsaicin, a transdermal absorption enhancer, and Diclofenac in traces, probably a contaminant from other productions of the same plant). Moreover, the presence of several trace elements, including those potentially toxic to humans, was assessed by ICP-MS analysis. 
Conclusions. The case discussed is a new case of “medicines in disguise” never reported
in literature, and shows the presence of tangible risks for public health.

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Authors

Maria Cristina Gaudiano - Istituto Superiore di Sanità

Paola Bertocchi - Centro Nazionale Controllo e Valutazione dei Farmaci, Reparto Farmaci Chimici, Istituto Superiore di Sanità

Daniela De Orsi

Livia Manna - Centro Nazionale Controllo e Valutazione dei Farmaci, Reparto Farmaci Chimici, Istituto Superiore di Sanità

Eleonora Antoniella - Centro Nazionale Controllo e Valutazione dei Farmaci, Reparto Farmaci Chimici, Istituto Superiore di Sanità

Andrea Rodomonte - Centro Nazionale Controllo e Valutazione dei Farmaci, Reparto Farmaci Chimici, Istituto Superiore di Sanità

Angela Sorbo - Dipartimento di Sicurezza alimentare, Nutrizione e Sanità pubblica veterinaria, Istituto Superiore di Sanità

Federica Aureli - Centro Nazionale Controllo e Valutazione dei Farmaci, Reparto Farmaci Chimici, Istituto Superiore di Sanità

Monica Bartolomei - Centro Nazionale Controllo e Valutazione dei Farmaci, Reparto Farmaci Chimici, Istituto Superiore di Sanità

How to Cite
Gaudiano, M. C., Bertocchi, P., De Orsi, D., Manna, L., Antoniella, E., Rodomonte, A., Sorbo, A., Aureli, F., & Bartolomei, M. (2022). A case of medicine in disguise: motion sickness patches sold as medical devices containing active pharmaceutical substances. Annali dell’Istituto Superiore Di Sanità, 58(4), 254-263. Retrieved from https://annali.iss.it/index.php/anna/article/view/1508
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