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Recessive mutations in genes coding for enzymes of the kynurenine pathway — namely kynureninase and 3-hydroxyanthranilic-acid 3,4-dioxygenase — lead to combined vertebral, anal, cardiac, tracheo-esophageal, renal, and limb (VACTERL) congenital malformations (76)

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Furthermore, sourcing introduces uncertainty in sterility and formulation integrity, which may represent a more immediate and clinically relevant risk than theoretical biologic effects, particularly given the potential for nonsterile preparation, contamination, or inconsistent formulation in nonregulated injectable products