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Moderate deficiency may include obvious macrocytic anemia, glossitis, as well as some mild or subtle neurological features, such as distal sensory impairment.[] Severe deficiency is characterized by bone marrow suppression, neurological features, and the risk of cardiomyopathy

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Copper accumulation presents another concern with extended use

12 Their use is restricted to a maximum of two years, partly due to evidence from animal studies showing a possible increased incidence of a bone cancer called osteosarcoma

The safest interpretation is that without explicit Category 1 placement, compounding carries significant regulatory uncertainty