Effects of nirmatrelvir/ritonavir (Paxlovid) on the nervous system: analysis on adverse events released by FDA.

Abstract

Background: Nirmatrelvir/ritonavir, commonly known as Paxlovid, is one of the main drugs used to treat COVID-19. Neurological disorders are among the adverse drug reactions (ADRs) linked to Paxlovid, yet comprehensive data-mining studies based on real-world neurological adverse events induced by Paxlovid are lacking.

Methods: It is an observational study, to reduce the risk of bias affected by COVID-19 disease, our study included only patients with COVID-19 disease. In this case, disproportionate analysis is performed using the Report Odds Ratio (ROR) and its 95% Confidence Interval (CI).

Results: We screened and compared all medications associated with COVID-19 (N = 439) and found that 22 of these were linked to neurological adverse reactions. Paxlovid was associated with a threefold greater number of neurological adverse events compared to all other drugs combined (N = 11,792), with a strong signal value (ROR = 2.27).

Conclusions: Compared to all other COVID-19-related drugs, Paxlovid has the highest number and stronger signal value for neurologic-related adverse reactions. Clinicians should pay special attention to female patients taking Paxlovid within the first 30 days, monitoring for symptoms such as dysgeusia, ageusia, headache, and anosmia. In addition, headache and anosmia are not uncommon occurrences as mentioned in the instructions and should be noted.