FDA still silent three months after panel backed six compounded peptides
Adverse event filings and two intubations at a Las Vegas longevity festival are cited as safety questions mount while the agency deliberates.
DO
By Daniel Okafor · Regulatory Correspondent
Oct 14 21:44 ETSource: Medical Daily
The wire
- 01The Pharmacy Compounding Advisory Committee voted 8-6 with one abstention in July to recommend BPC-157, KPV and TB-500 for compounding use; MOTS-c passed 7-5, Semax and epitalon also cleared, emideltide was rejected.
- 02FDA scientists had found insufficient efficacy evidence and flagged possible liver damage and allergic reactions, including a 2020 study showing liver toxicity signs in rats and dogs given BPC-157.
- 03Adverse event reports cited are voluntary and unverified; two women injected with peptides at RAADFest on July 13, 2025 were intubated and have recovered.
From the source
Read at medicaldaily.comAs FDA Weighs Wider Peptide Access, Adverse Event Reports and Two Las Vegas Intubations Sharpen Safety Questions
Nearly three months after an FDA advisory panel voted to ease restrictions on six unapproved peptides , the agency still has not issued a final decision. In the meantime, a KFF Health News investigation published Oct. 13 describes people who say BPC-157 and similar products left them with migraines, eye pain, fatigue, and months of anxiety.
