Real-World Pharmacovigilance Analysis of Drug-Induced Decreased Cardiac Ejection Function: Evidence from the FAERS Database (2004-2024) - PubMed
5 hours ago
- #pharmacovigilance
- #cardiotoxicity
- #FAERS
- Study analyzed drug-induced Decreased Cardiac Ejection Function (DCEF) using FAERS data from 2004-2024.
- 86 drugs were significantly associated with DCEF, including trastuzumab and doxorubicin.
- 50 drugs, such as clozapine and rofecoxib, showed novel safety signals not previously labeled for DCEF.
- Time-to-onset analysis revealed an 'early-failure' pattern, with highest risk shortly after treatment initiation.
- Median time-to-onset varied: 42 days for rituximab and 140 days for doxorubicin.
- Patients aged 65-85 years and those weighing 70-89 kg were most frequently affected.
- Findings suggest need for periodic echocardiographic monitoring, especially for high-risk drugs like mitoxantrone and trastuzumab.
- Early-phase monitoring is crucial for 'early-failure' agents, while extended follow-up is needed for drugs like doxorubicin.