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Drug-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system
Dongxuan Li1, Liyang Dai2, Jun Zhu1
1Department of Pharmacy, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Expert Opinion on Drug Safety
|August 23, 2024
Summary
This study identified 734 drugs linked to erectile dysfunction (ED) using FDA data. Finasteride and urologicals showed the highest reporting frequency and signal strength for drug-induced ED.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Urology
Background:
- Comprehensive risk data for drug-induced erectile dysfunction (ED) is limited.
- Existing data lacks quantitative and comparative analysis of ED risks associated with various medications.
Purpose of the Study:
- To provide comprehensive quantitative and comparative risk data for drug-induced ED.
- To identify potential culprit drugs and drug classes associated with ED.
Main Methods:
- Analysis of 20,098 ED reports from the FDA Adverse Event Reporting System (FAERS) database (2004-2023).
- Utilized disproportionality analysis with the reporting odds ratio (ROR) method.
- Identified drugs with positive signals for ED occurrence.
Main Results:
- 734 distinct drugs across 74 drug classes were associated with ED.
- Finasteride had the highest reporting frequency and signal strength.
- 209 drugs showed a significant relationship with ED; compound preparations posed a higher risk than single active ingredients.
Conclusions:
- This study provides integrated quantitative and comparative ED risk data for 734 drugs.
- Findings offer valuable reference for regulators, healthcare professionals, and drug safety management.
- Highlights the need for careful consideration of drug-induced ED risks, especially with compound formulations.
Keywords:
Erectile dysfunctionFDA adverse event reporting systemadverse drug reactiondisproportionality analysispharmacovigilanceMore Related Videos
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