ProPublica flags immune reaction risk as FDA reopens peptide compounding
Posted by freya530 in Safety & Side Effects - 3 points, 7 comments.
ProPublica put out a piece on the FDA potentially reversing course on compounded peptides, and the part that stuck with me was the immune reaction angle. They cite the FDA's own reasoning from 2023 about injectable peptides carrying a real risk of immune responses, ranging from no clinical signs to full on serious events. That line of reasoning is what got 19 research peptides pulled from compounders in the first place.
Now the same agency is asking an advisory panel whether to put some of those peptides back on the allowed list. That feels like whiplash to me. I am not against peptides, I run a small stack myself. But loosening safety guardrails because of political pressure, with the same risk profile still on paper, does not sit right.
For those of you following the FDA panel news, do you think immune reaction risk is being treated seriously enough in these discussions, or is it getting glossed over?
Comments
- grinder265: Yeah the whiplash is real, and ngl the immune angle is the part I'd want them hammering on way harder before anything gets loosened. Anti-drug antibodies are sneaky because you can feel fine on paper, then one day your dosing stops working and you have no clue why. For me that is the scariest flavor of side effect, the one you only catch in retrospect. Curious what others think tho, are people here actually getting ADA titers checked on longer runs, or is that just not something anyone does out
- fasted_scientist: Tbf I haven't seen anyone post actual ADA numbers in here, and I've been lurking a while. Most people seem to judge it by how they feel or by IGF-1 drifting, not by antibody titres. Could just be nobody's asking their GP for it.
- freya530: That is a fair point. Most of us just go by how we feel, fwiw. I haven't seen anyone mentioning antibody titres either. It makes me wonder if people are actually having reactions and just not realizing it. Do you think a GP would even know what to look for if someone asked for ADA numbers? Seems like a stretch for most primary care offices.
- weekendnate: Not in a trial setting, no way. I rotate compounds more than I'd like to admit and ADA testing is expensive enough that I've never pulled the trigger. Curious if anyone has a lab that runs it without a doc order, because that would change how seriously I take longer runs on anything immunogenic.
- freya530: ADA testing for what specifically though? Antiphospholipid antibodies, or anti-drug antibodies more broadly? Those are different panels and the cheaper direct ELISA kits you can order online are kind of a crapshoot for sensitivity. If you're rotating compounds and worried about immunogenicity, baseline plus periodic screening is the only thing that would actually catch a developing response before it bites you.
- freya530: Honestly that is exactly what I keep coming back to. You can do everything right and still get blindsided by ADA development because there is no symptom until there is a symptom. I have never had titers drawn personally. Fwiw I do not think I have seen anyone in here mention it either, which kinda proves your point about it being a trial-only thing. Hard to make an informed call on something nobody is measuring.
- tiredmira: Honestly the GP thing is basically what worries me too. Most walk in and say "fatigue" or "rash" and get told it's stress. For me tracking HRV was the only early signal I caught on one compound, before any obvious symptom. Labs feel like the missing piece nobody's running. 😅
Community discussion - research and educational context only. Not medical advice.