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Safety concerns included uncharacterized immunogenicity (the risk that injected peptides trigger immune reactions), inadequate impurity and endotoxin testing in available raw material, the unresolved free base versus acetate salt form distinction, and, for BPC-157 specifically, an angiogenesis mechanism that raises theoretical cancer-risk concerns for certain patient populations

Within a 68-page briefing document for the committee meeting, the FDAs own experts wrote that there is a lack of evidence to make a conclusion on the effectiveness of BPC-157 for treating ulcerative colitis and there already are FDA-approved drugs available to treat ulcerative colitis, and they proposed not adding BPC-157 to the 503A Bulks List

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[209] reported widespread alterations in sperm DNA methylation in obese and diabetic men, particularly at loci associated with metabolism, development, and inflammation [209]

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