| Autor: |
Oketch-Rabah HA; United States Pharmacopeial Convention (USP), Rockville, MD, USA., Hardy ML; United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA.; Chair, United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Patton AP; Tufts University School of Medicine, Boston, MA, USA., Chung M; Tufts University School of Medicine, Boston, MA, USA., Sarma ND; United States Pharmacopeial Convention (USP), Rockville, MD, USA., Yoe C; United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Ayyadurai VAS; United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Fox MA; United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Jordan SA; Chair, United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Mwamburi M; Chair, United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Mould DR; Chair, United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Osterberg RE; Chair, United States Pharmacopeial Convention (USP) Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Hilmas C; FDA liaison to the USP Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Tiwari R; FDA liaison to the USP Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Valerio L Jr; FDA liaison to the USP Dietary Supplements Safety Modeling Expert Panel, Rockville, MD, USA., Jones D; Consortium for Health and Military Performance, Uniformed Services University of the Health Sciences, Bethesda, MD, USA., Deuster PA; Consortium for Health and Military Performance, Uniformed Services University of the Health Sciences, Bethesda, MD, USA., Giancaspro GI; United States Pharmacopeial Convention (USP), Rockville, MD, USA. |
| Abstrakt: |
Military personnel use dietary supplements (DS) for performance enhancement, bodybuilding, weight loss, and to maintain health. Adverse events, including cardiovascular (CV) effects, have been reported in military personnel taking supplements. Previous research determined that ingestion of multi-ingredient dietary supplements (MIDS), can lead to signals of safety concerns. Therefore, to assess the safety of MIDS, the Department of Defense via a contractor explored the development of a model-based risk assessment tool. We present a strategy and preliminary novel multi-criteria decision analysis (MCDA)-based tool for assessing the risk of adverse CV effects from MIDS. The tool integrates toxicology and other relevant data available on MIDS; likelihood of exposure, and biologic plausibility that could contribute to specific aspects of risk.Inputs for the model are values of four measures assigned based on the available evidence supplemented with the opinion of experts in toxicology, modeling, risk assessment etc. Measures were weighted based on the experts' assessment of measures' relative importance. Finally, all data for the four measures were integrated to provide a risk potential of 0 (low risk) to 100 (high risk) that defines the relative risk of a MIDS to cause adverse reactions.We conclude that the best available evidence must be supplemented with the opinion of experts in medicine, toxicology and pharmacology. Model-based approaches are useful to inform risk assessment in the absence of data. This MCDA model provides a foundation for refinement and validation of accuracy of the model predictions as new evidence becomes available. |
