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[6] In summary, aside from hypersensitivity, the use of pyridoxine should be guided by clinical necessity, and caution exercised in populations vulnerable to potential risks of excipients or overdose

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The primary concern for the FDA was the lack of large-scale, randomized controlled trials, which are the gold standard for new drug approval

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Additionally, you should take your own preferences and needs into account as well as the suggestions offered by your healthcare provider