Regulatory and hepatotoxicity profi le of dietary supplements
Bulgarian Medical Journal, 16, 2022, № 1, 36-41, 13-17.
A. Balkanska-Mitkova1, M. Dimitrova2, M. Kondeva-Burdina1
1 Department of Pharmacology, Pharmacotherapy and Toxicology, Faculty of Pharmacy, MU – Sofia
2 Department of Organization and Economics of Pharmacy, Faculty of Pharmacy, MU – Sofia
Abstract. In recent years, there has been an increased use of dietary supplements (DS) as prevention, prophylaxis and treatment of various chronic diseases. In order to strengthen controls on the marketing, use and safety of dietary supplements, the European Commission has taken major regulatory steps to harmonize the criteria for DS and to ensure that no misleading information is provided to put people’s health at risk. However, excessive use, uncontrolled consumption or exposure to higher than recommended acceptable intakes can cause liver toxicity and pose serious health threats. Studies have shown that the timely diagnosis of liver toxicity associated with dietary supplement use is challenging due to the overwhelming similarity to drug-induced liver injury (DILI). Studies have shown that dietary supplements are perceived by patients and consumers as generally safe, effective and without risk of complications for long-term health. The scientifi c literature, however, refutes this belief. There are numerous reports and reports of hepatotoxicity. Most cases of dietary supplement-induced hepatotoxicity cannot be reproduced in experimental animal models. It is therefore difficult to identify the pathogenetic factors. Furthermore, another disadvantage is that patients rarely inform personal physicians or pharmacists about their use, due to the easy access to them without having the physician’s approval or the availability of a prescription to take a supplement. Improved education and public awareness of the benefi ts and potential risks associated with the use of dietary supplements is desirable to ensure that suspected adverse effects are formally reported. More stringent regulatory measures are needed to demonstrate efficacy and safety when introducing dietary supplements on the market.
Key words: dietary supplements, regulatory control, toxicological profi le, benefi ts, risks
Address for correspondence: Assoc. Prof. Maria Dimitrova, M.Pharm, MSc, PhD, Department of Organization and Economy of Pharmacy, Faculty of Pharmacy, Medical University, 2 Dunav, str Bg – 1000 Sofia,
e-mail: mdimitrova@pharmfac.mu-sofia.bg