FDA's compounding safety review states that GHRP-2 may pose a risk for immunogenicity due to potential aggregation and peptide-related impurities, and notes it contains an unnatural amino acid that adds to characterization complexity. The agency is also aware of reports of serious adverse events in patients who received GHRP-2, including increased insulin requirement to maintain blood glucose, death in critically ill study subjects, infection and pancreatitis, though it states causality has not been established.[2]
- FDA explicitly states causality between GHRP-2 and these adverse events, including death, has not been established; the population described appears to be critically ill patients, which differs from healthy research-market use.
- This regulatory summary does not quantify event frequency. FDA's own page links the GHRP-2 entry to one published study (Van den Berghe and colleagues, 1999, growth hormone-releasing peptide-2 with thyrotropin-releasing hormone in critically ill patients), but that study's abstract does not itself report death, infection or pancreatitis, so the specific data behind FDA's statement remains unlocated pending its full text.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Newly authored during the fresh deep-evidence pass from a directly inspected regulator/analytical passage not previously reflected in a claim for this compound. No qualified clinical review.