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Special Considerations

B12-deficient individuals who are at risk for Leber’s optic atrophy should not be given cyanocobalamin to treat the B12 deficiency. Leber’s optic atrophy is a genetic disorder caused by chronic cyanide intoxication (present in tobacco smoke, alcohol, and some plants). Reduced serum B12 concentrations have been associated with a reduced ability to detoxify the cyanide in exposed individuals (Foulds, 1968, 1969a, b, 1970; Wilson and Matthews, 1966). Cyanocobalamin may increase the risk of irreversible neurological damage (from the optic atrophy). Hydroxocobalamin is a cyanide antagonist and therefore not associated with adverse effects when given to these individuals.

Dose-Response Assessment

The data on adverse effects of B12 intake were considered not sufficient for a dose-response assessment and derivation of a UL.

Intake Assessment

In 1986 approximately 26 percent of adults in the United States took a supplement containing B12 (Moss et al., 1989). Although no UL can be set for B12, an exposure assessment is provided here for possible future use. Based on data from the Third National Health and Nutrition Examination Survey (see Appendix H), the highest median intake of B12 from diet and supplements for any life stage and gender group was for males aged 31 through 50 years: 17 µg/ day. The highest reported intake at the ninety-fifth percentile was 37 µg/day for pregnant females aged 14 through 55 years.

Risk Characterization

On the basis of the review of data involving high-dose intakes of B12, there appear to be essentially no risks of adverse effects to the general population even at the current ninety-fifth percentile of intake noted above. Furthermore, there appear to be no risks associated with intakes of supplemental B12 that are more than two orders of magnitude higher than the ninety-fifth percentile of intake. Although there are extensive data showing no adverse effects associated with high intakes of supplemental B12, the studies in which such intakes were reported were not designed to assess adverse effects.

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