Post-marketing safety concerns with dolutegravir: a pharmacovigilance study based on the FDA adverse event reporting system database

The long-term safety of DTG requires reassessing its risk-benefit ratio. To mitigate the risk of irreversible organic damage, a structured risk management strategy is essential. This strategy should encompass restrictions on contraindicated populations, enhanced monitoring of high-risk subgroups, and the implementation of post-marketing prospective cohort studies to ensure the sustainability of antiviral therapy.