Post-marketing Surveillance of Long-term Use of Stérimar™ Seawater-based Nasal Irrigation Solutions

Autor: Marco Bertini, Alejandro Jimenez Chobillon, Josip Culig
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Popis: 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.
Databáze: OpenAIRE