Objective:

To evaluate the risk signals of drug-related ARDS and identify potential high-risk drug classes using the US FDA Adverse Event Reporting System (FAERS).

Approach:

Key Findings:

• 15,986 drug-related ARDS reports were included, predominantly in middle-aged and older adults.
• The five most frequently reported drugs were mycophenolic acid, methotrexate, rituximab, tacrolimus, and amiodarone.
• Strong associations for ARDS risk were found with prednisone, mycophenolic acid, amiodarone, and cytarabine.
• 22 drugs were significantly associated with ARDS risk in multivariable analyses.
• The median time to ARDS onset was 30 days, with 75% of cases occurring within 150 days after treatment initiation.

Interpretation:

The study identified multiple drug classes with significantly elevated ARDS risk, including immunosuppressants, antineoplastic agents, glucocorticoids, cardiovascular drugs, and NSAIDs.

Limitations:

• The study relies on spontaneous reporting data, which may be subject to underreporting and reporting bias.
• Causality cannot be definitively established due to the observational nature of the data.

Conclusion:

The findings provide important evidence for clinical monitoring of high-risk medications.

Attribution Notice

This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.