Objective:

To investigate the association between atorvastatin and neurological adverse events (NAEs) while accounting for confounding by indication.

Approach:

• Data Source: Utilized the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q3 2023.

Key Findings:

• Identified 50 NAE signals for atorvastatin, with 32 remaining significant after exclusions.
• Strongest signals included neuromuscular junction disorders (myasthenia gravis: PRR = 5.65, χ2 = 748.22, EBGM05 = 4.82), peripheral neuropathies (axonal neuropathy: PRR = 6.15, χ2 = 117.78, EBGM05 = 4.14), and central nervous system disorders (encephalitis toxic: PRR = 7.76, χ2 = 17.11, EBGM05 = 2.39).
• Exceptional signals included acute necrotising myelitis (PRR = 832.92, EBGM05 = 38.61) and vibration syndrome (PRR = 37.02, EBGM05 = 14.51).

Interpretation:

The study provides real-world evidence of multiple strong neurological safety signals associated with atorvastatin, warranting further validation.

Limitations:

• Potential underreporting and variability in reporting practices in the FAERS database.
• The analysis may not capture all adverse events due to the nature of spontaneous reporting.

Conclusion:

The findings indicate a need for further validation of neurological adverse events associated with atorvastatin.