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High lipophilicity leads to the poor absorption of drug molecules

[8] Patients with significant alcohol intake or thiamine deficiency also require precaution: chronic heavy alcohol use can deplete thiamine (vitamin B) and taking ALA in the setting of thiamine deficiency has been associated with serious health risks (including a condition resembling Wernickes encephalopathy)

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In explaining its decision, the agency flagged concerns about complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization, the potential for aggregation and a lack of human safety data