Baloxavir Marboxil with lower hepatic toxicity safer option to oseltamivir in influenza patients with liver diseases: Study

A recent study published in the recent issue of BMC Infectious Diseases looked into the post-market safety profiles of two commonly prescribed antiviral drugs, the Oseltamivir and Baloxavir Marboxil against seasonal influenza. Given their comparable efficacy, this analysis provided essential clinical references by exploring adverse events (AEs) linked with these medications.

The study meticulously analyzed data from the FDA Adverse Event Reporting System (FAERS) and covered reports from the first quarter of 2004 to the fourth quarter of 2022. This study utilized advanced data mining techniques like the reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network and Multiple Gamma Poisson Shrinkage to examine AEs linked to both Oseltamivir and Baloxavir Marboxil. A Venn analysis was also conducted to compare and identify specific AEs associated with each drug. The analysis incorporated data from a total of 15,104 Oseltamivir cases and a total of 1,594 Baloxavir Marboxil cases. This revealed 21 common AEs affecting various domains including neurological, psychiatric, gastrointestinal, dermatological, respiratory and infectious systems.

Oseltamivir was associated with 221 significantly specific AEs. Few notable examples include appendicolith (ROR 459.53), infantile acne (ROR 368.65), acute macular neuroretinopathy (ROR 294.92), proctitis (ROR 245.74) and senile purpura (ROR 154.02). The medical events (DMEs) linked to Oseltamivir included fulminant hepatitis (ROR 12.12, n=27), ventricular fibrillation (ROR 7.68, n=64) and toxic epidermal necrolysis (ROR 7.21, n=75). Baloxavir Marboxil expressed 34 specific AEs, including melaena (ROR 21.34, n=23), hemorrhagic cystitis (ROR 20.22, n=4), paralytic ileus (ROR 18.57, n=3), and hemorrhagic diathesis (ROR 16.86, n=3). DMEs related to Baloxavir Marboxil included rhabdomyolysis (ROR 15.50, n=26).

The study highlighted the need for careful monitoring of fulminant hepatitis during Oseltamivir treatment in patients with pre-existing liver conditions. The potential for Oseltamivir to induce abnormal behavior in adolescents, also warrants close observation. But, Baloxavir Marboxil emerges as a potential alternative for patients with liver issues due to its lower hepatic toxicity. The risk of rhabdomyolysis during Baloxavir Marboxil treatment points towards careful monitoring of relevant indicators in symptomatic patients. Overall, this comprehensive data will help equip clinicians with valuable insights to enhance the existing understanding of the safety profiles of these influenza treatments in real-world settings. 

Source:

Li, Y., Wang, X., Liao, Y., Zeng, Y., Lin, W., & Zhuang, W. (2024). Safety analysis of Oseltamivir and Baloxavir Marboxil after market approval: a pharmacovigilance study based on the FDA adverse event reporting system. In BMC Infectious Diseases (Vol. 24, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s12879-024-09339-4