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Good scientific practice of using worldwide post-marketing surveillance data to ensure safety with HAALI BDDE cross-linked hyaluronic acid fillers

Aliaxin fillers (HAALI), produced by IBSA Farmaceutici Italia SrL (Italy), are biodegradable, non-pyrogenic, 1,4-butanediol diglycidyl ether cross-linked hyaluronic acid (HA) hydrogels. The formulations are tailored for different clinical indications, ensuring precise and natural outcomes. Their coh...

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Bibliographic Details
Published in:Drugs in Context 2024-12, Vol.13, p.1-10
Main Authors: Sundaram, Hema, Molina, Beatriz, Buttura da Prato, Editta, Siquier-Dameto, Gabriel, Zazzaron, Michela, Cigni, Clara, Grimolizzi, Franco
Format: Article
Language:English
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Summary:Aliaxin fillers (HAALI), produced by IBSA Farmaceutici Italia SrL (Italy), are biodegradable, non-pyrogenic, 1,4-butanediol diglycidyl ether cross-linked hyaluronic acid (HA) hydrogels. The formulations are tailored for different clinical indications, ensuring precise and natural outcomes. Their cohesivity and tissue integration capabilities are associated with relatively few adverse events (AEs), supporting their widespread use in aesthetic treatments. This article examines the real-world safety profile of HAALI fillers derived from worldwide post-marketing surveillance data.BackgroundAliaxin fillers (HAALI), produced by IBSA Farmaceutici Italia SrL (Italy), are biodegradable, non-pyrogenic, 1,4-butanediol diglycidyl ether cross-linked hyaluronic acid (HA) hydrogels. The formulations are tailored for different clinical indications, ensuring precise and natural outcomes. Their cohesivity and tissue integration capabilities are associated with relatively few adverse events (AEs), supporting their widespread use in aesthetic treatments. This article examines the real-world safety profile of HAALI fillers derived from worldwide post-marketing surveillance data.Post-marketing surveillance was registered by the manufacturer from January 2018 to September 2023. During this period, product complaints were globally gathered from healthcare practitioners and consumers, relating to technical issues or safety and product-related adverse events.MethodsPost-marketing surveillance was registered by the manufacturer from January 2018 to September 2023. During this period, product complaints were globally gathered from healthcare practitioners and consumers, relating to technical issues or safety and product-related adverse events.No discernible trend or substantial escalation in AEs across the entire product range were observed during the surveillance period (p>0.05). No statistically significant increases (p>0.05) in the frequency or severity of safety incidents and AEs were observed. The most frequently observed AEs were oedema (26%) and swelling (19%).ResultsNo discernible trend or substantial escalation in AEs across the entire product range were observed during the surveillance period (p>0.05). No statistically significant increases (p>0.05) in the frequency or severity of safety incidents and AEs were observed. The most frequently observed AEs were oedema (26%) and swelling (19%).The analysed data further support and confirm the high safety profile of the HAALI fil
ISSN:1745-1981
1740-4398
DOI:10.7573/dic.2024-10-6