Adverse Reaction Prediction and Pharmacovigilance of Nutraceuticals

Nutraceuticals, such as isolated nutrients, dietary supplements, and herbal products, have been widely used due to potential therapeutic and beneficial properties. It is also increasingly realized that specific nutraceuticals may carry safety risks, which concern not only consumers but also regulatory authorities and the nutraceutical industry. Although clinical trials remain the principal way of nutraceuticals safety assessment, other complementary methods have also been developed and appreciated, especially those based on big data analysis. This chapter describes two examples of evaluating potential safety concerns of folic acid, a widely used nutraceutical products. First, the drugs with Food and Drug Administration (FDA) boxed warnings due to nephrotoxicity are used as reference drugs to detect the renal risks of folic acid. Second, several potential side effects of folic acid are identified with the pharmacovigilance statistics of the FDA Adverse Event Reporting System. Hopefully, these application cases could widen the horizon about the big data-based safety assessment of nutraceuticals for those who are interested in this issue.