Post-Marketing Safety Concerns with Nirmatrelvir: A Disproportionality
Analysis of Spontaneous Reports Submitted to the FDA Adverse Event
Aim: Nirmatrelvir as a new 3CL protease inhibitor for treating COVID-19
drug of antiviral drug, the potential side effects have not yet been
fully studied yet. The aim of this study was to identify potential risk
of Nirmatrelvir by analyzing post-marketing safety data based on the
largest publicly available worldwide pharmacovigilance database.
Methods: We analyzed Nirmatrelvir adverse events to detect and
characterize relevant safety signals based on the FDA Adverse Event
Reporting System database in 2022. Case/non-case approach were used to
estimate the reporting odds ratio (ROR) and information component (IC)
with relevant confidence intervals (95% CI) for AEs with ≥4 counts.
Results: Total of 26846 cases were included. Disease recurrence
[ROR(95%CI)=9.80(8.50-11.3)] and urticaria
[ROR(95%CI)=1.91(1.69-2.17)] were the main safety signals. In
addition, abdominal pain upper and skin toxicity were two specific
safety signals of Nirmatrelvir. In pregnant population, a significant
increased ROR was found in life-threatening
[ROR(95%CI)=5.12(1.38-19.00)]. Conclusion: We identified that
disease recurrence, dysgeusia, abdominal pain upper and skin toxicity
were the main and specific safety signals of Nirmatrelvir. Clinician and
pharmacist should pay attention on these AEs. Notably, a potential risk
of Nirmatrelvir in pregnant population should be alerted.