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The agency flagged three adverse events in its FAERS database tied to compounded injectable BPC-157, including a case in which a patient developed diffuse hyperpigmentation and gingival darkening after using a blended BPC-157/TB-500 product labeled "research purposes only." The safety concern most specific to BPC-157 is its mechanism of action

Using mitragynine as a surrogate of the complex mixture, inhibition of intestinal and hepatic CYP3A (time-dependent and reversible) and hepatic CYP2D6 (reversible) by mitragynine was incorporated into the model based on in vitro observations

Daily use for 12 weeks reportedly gives better results than sporadic use for 6 months

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