1. Reporting Adverse Events from Dietary Supplements (For the Warfighter) DoD Human Performance Resource Center Website address: hprc-online.org Contact e-mail: supplements@usuhs.edu 1 v: 081512

2. Objectives Raise awareness about potential adverse effects of dietary supplements (DS) Provide examples of methods for reporting adverse events (AE) associated with DS use 2

3. Introduction The use of DS is prevalent in the U.S. military. In a recent survey, 53% of U.S. Army soldiers reported use of DS one or more times per week. 1 In another survey, 37% of U.S. Army Rangers indicated that they used DS. 2 Some of these DS have caused or contributed to AE in many individuals. 3 1. Lieberman HR, Stavinoha TB, McGraw SM, White A, et al. (2010). Use of dietary supplements among active-duty US Army soldiers. The American Journal of Clinical Nutrition. 92(4): 985-95. 2. Johnson A, Haley CA, Ward CA. (2007). Hazards of dietary supplement use. Journal of Special Operations Medicine. 7(1)(Winter): 30-38.

4. Case 1: Real-life scenarios of AEs associated with DS 4 A young soldier in cardiac failure was seen at a military healthcare facility. His liver enzymes were exceptionally high. He had no medical history, illness, or injury that could explain any of his symptoms. Despite ACLS interventions, he died. Inventory of his room revealed cans of nutritional supplements stacked floor to ceiling.

5. Case 2: Real-life scenarios of AEs associated with DS 5 Iraq, Camp Taji: A 35-year-old male soldier, otherwise healthy, consumed one scoop of “NO Explode” mixed with water and went to the gym. He also had consumed an energy drink from the DFAC one hour earlier. Shortly after starting his workout, he began to feel lightheaded and dizzy, and he almost fainted while getting up after a set of bench presses. He was taken to the ER and recovered after IV fluids and rest. Labs were normal. It was 120 o F outside and about 75 o F in the gym.

6. Case 3: Real-life scenarios of AEs associated with DS 6 A 21-year-old Marine Lance Corporal was transferred by ambulance from the dining facility of Camp Leatherneck to the Bastion Role 3 Hospital after passing out for 30-60 seconds while standing in line. The patient stated he had been up for 36 hours. In the previous 24 hours he had been using both Jack3d and energy drinks. Patient underwent an evaluation in the Emergency Room. It was determined there was no other underlying cause for his episode of syncope.

7. Case 4: Real-life scenarios of AEs associated with DS 7 A 27-year-old Marine Sergeant passed out while in the hygiene facilities. He was evaluated at the Combined Aid Station on Camp Leatherneck. History revealed that he had been restricting his routine diet and focusing on supplement use. He had a carton of soy milk with protein powder for dinner the night before. He was regularly using Jack3d as a pre-workout supplement.

8. Some DS have been associated and/or suspected with AE in many individuals, but most AE go unreported! 8

9. Why is it important to report adverse events? The Food and Drug Administration (FDA) does not review DS for efficacy and safety prior to marketing. Some unsafe and tainted DS are on the market. Reporting AE from DS sends a message that helps agencies identify unsafe products and ingredient combinations. 9

10. Some supplements are more likely to be associated with AEs, but the only way to differentiate those that are associated from those that are not is through adequate reporting of AEs. 10

11. REPORTING ADVERSE EVENTS 11

12. Ways to Report Adverse Events Natural Medicines Watch –The current method of choice for the Department of Defense MedWatch (FDA) 12

13. NATURAL MEDICINES WATCH Report AE using the Natural Medicines Watch program through the Natural Medicines Comprehensive Database or the Human Performance Resource Center 13

14. All AE reported through Natural Medicines Watch go to the FDA (i.e., to MedWatch)! 14

15. 1. Type hprc-online.org into your browser hprc-online.org

16. 2. Click on the Natural Medicines icon

17. 3. Click on the Natural Medicines Watch icon

18. 4. Complete the electronic form

19. 4. Complete the electronic form (cont.)

22. A link to most commercially available supplements is provided

23. 4. Complete the electronic form (cont.)

25. 5. Submit when done

26. 26 MEDWATCH Report directly to FDA through MedWatch MedWatch Form 1-800-332-1088 1-800-FDA-0178 FAXFAX

27. 1. Type https://www.accessdata.fda.gov/scripts/medw atch/medwatch-online.htm into your web browser https://www.accessdata.fda.gov/scripts/medw atch/medwatch-online.htm https://www.accessdata.fda.gov/scripts/medw atch/medwatch-online.htm

28. 2. Click the BEGIN button on the right and submit when done

29. Conclusion Adverse events SUSPECTED of being associated with DS should be reported. –This is the primary way for unsafe DS to be identified and removed from the market. Adverse events can be reported by consumers through: –NATURAL MEDICINES WATCH The current method of choice for the Department of Defense Easy to use and conveys information directly to the FDA –MEDWATCH 29