Marco Bertini¹*, Alejandro Jimenez Chobillon² and Josip Culig³

¹Laboratori Baldacci SpA, Pisa, Italy
²National Institute of Respiratory Diseases Ismael Cosío Villegas, Mexico DF, Mexico
³Department of Medicine and Clinical Pharmacology, University of Applied Health Sciences, Zagreb, Croatia

*Corresponding Author: Marco Bertini, Laboratori Baldacci SpA, Pisa, Italy.

Received: August 22, 2022; Published: October 12, 2022

Abstract

Saline nasal irrigation (SNI) is a simple, easy-to-use and efficient method to keep a healthy nasal mucosa and to be used as an adjuvant treatment in different sinonasal conditions. Although its efficacy has been clinically demonstrated, the long-term safety profile of SNI has only been empirically addressed. The aim of this article is to present the post-marketing surveillance (PMS) data of Stérimar, a pioneer brand of nasal hygiene offering a wide range of seawater-based solutions. The PMS data presented in this article was collected from January 2018 to April 2021 in four countries (France, United Kingdom, Mexico and Australia) and from different sources (social media, email, health authorities, distributors, among others). In that period, more than 23 million units of these seawater-based products were sold in these markets with only 37 reported complaints. The most frequent complaints were considered not serious adverse events, mostly related to getting the product into the eyes, epistaxis and pain/burning sensation. This data, along with the high-quality manufacturing process of these products confirms the long-term safety profile of this range of SNI products in babies, children and adults.

Keywords: Seawater; Nasal; Hygiene; Safety; Adverse Events

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Citation

Citation: Marco Bertini., et al. “Post-marketing Surveillance of Long-term Use of Stérimar™ Seawater-based Nasal Irrigation Solutions".Acta Scientific Otolaryngology 4.11 (2022): 03-10.

Copyright

Copyright: © 2022 Marco Bertini., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.