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However, a multicenter study in 5,485 subjects with cardiovascular disease or diabetes mellitus showed that daily supplementation with folic acid (2.5 mg), vitamin B 12 (1 mg), and vitamin B6 (50 mg) lowered homocysteine concentrations but had no effect on fracture risk compared to placebo (118)

Quality varies significantly between sources, and independent testing for purity and potency is not consistently available

Prescribing information notes that allergic-type reactions, including anaphylactoid symptoms, have been reported in rare cases

Theyll review the available data, which involves some evidence of safety, to decide whether they should allow this new path, Cohen says