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In a statement, the FDA commissioner, Martin Makary, said the drug would now be approved for patients with cerebral folate deficiency (CFD), a condition sometimes associated with autism spectrum disorders

Some patients have also experienced a hypersensitivity reaction following intramuscular injection that has resulted in anaphylactic shock and death

Linus Pauling Institute

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The goal is consistent daily administration over weeks, not aggressive short-term dosing

However, niacinamide at physiological doses (like those in prenatal vitamins or moderate supplements) is not known to be harmful