Safety evaluation of selective estrogen receptor degraders (SERDs) using real-world evidence from the FDA Adverse Event Reporting System (FAERS)
Ye Kang, Xue Sun, Da-sheng Dang, Yuan Yuan · 2025
Read Safety evaluation of selective estrogen receptor degraders (SERDs) using real-world evidence from the FDA Adverse Event Reporting System (FAERS) by Ye Kang, Xue Sun, Da-sheng Dang, Yuan Yuan (2025) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-12660727.txt.
Description
Ye Kang and co-authors mine drug safety reports for two breast cancer drugs in a 2025 paper. The drugs, elacestrant and fulvestrant, degrade the estrogen receptor that many breast tumors depend on. Using the United States FDA adverse event database from 2004 to 2024, the team hunted for risk signals in real-world use.
Reports naming elacestrant as the prime suspect numbered 6,636, and fulvestrant drew 9,120. Both drugs shared common complaints: nausea, vomiting, disease progression, raised liver enzymes, and hot flashes. Elacestrant leaned toward abnormal tumor markers and swallowing-tube reactions, while fulvestrant linked more to tumor spread and blood and lymph issues. Four statistical methods cross-checked the signals for pharmacovigilance.
Catalog record
| CREATOR | Ye Kang, Xue Sun, Da-sheng Dang, Yuan Yuan |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 38 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |