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As in this group of patients B12 symptomology often is not recognized and the effect of oral supplementation regularly is insufficient (as a result of the destruction of intrinsic factor production, among other things), a large number of them suffer from B12 deficiency

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High-risk groups include older adults, vegans, individuals with pernicious anaemia, those with malabsorption conditions such as Crohn's disease or coeliac disease, people taking metformin or proton pump inhibitors long-term, and those with recent nitrous oxide exposure including recreational use

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The FDA placed it in Category 2, which means it presents significant safety concerns including immunogenicity the risk that your own immune system mounts a response against it