Experience with OxyELITE Pro and Acute Liver Injury in Active Duty Service Members

Abstract

1,3-dimethylamylamine (DMAA) is a common additive in sport supplements that was banned by the FDA in 2013. Specifically, this additive received much publication for its role in causing adverse cardiovascular events, particularly sudden cardiac death. However, it has been our experience that products containing this additive may also lead to acute liver injury and liver failure. We present a series of seven cases encountered by a military treatment facility in Southern California which involved the use of OxyELITE Pro, a sport supplement containing DMAA, that all resulted in acute liver injury with two cases requiring transplant for acute liver failure. To our knowledge, this is the first case series reported involving OxyELITE Pro or other DMAA-containing supplements with a specific focus on acute liver injury. This review is limited by the paucity of clinical studies and trials based on OxyElite Pro and its effect on the liver. The presented cases are notably observation, and no standardized diagnostic or treatment protocol was utilized. This series is important to the general population as a whole due to the prevalence of sport supplement use, and is particularly important for practitioners who work with the military or athletic populations due to the high use in these demographics. These cases are followed by a brief discussion regarding DMAA.

Abuse liability of the dietary supplement dimethylamylamine

“…These findings suggest that DMAA may have potential to be abused. The serious adverse effects associated with DMAA (Eliason et al, 2012; Foley et al, 2014; Forrester, 2013; Young et al, 2012) may increase the risk of recreational use. Because DMAA produced discriminative stimulus and rewarding effects similar to abused psychostimulants, vulnerable individuals may be at risk of escalating doses to dangerously toxic levels, suggesting that restricting access to this compound may be appropriate.…”

“…More serious and life-threatening effects have also been reported, such as hemorrhagic stroke (Gee, 2010; 2012; Young et al, 2012), hepatotoxicity (Foley et al, 2014), myocardial infarction (Smith et al, 2014), and death (Eliason et al, 2012). Generally, DMAA is not taken alone, but as a component of weight-loss supplements, several of which also contain caffeine (Lammie, 2013).…”

“…Given the pressor action and widespread use of caffeine, a synergistic effect between DMAA and caffeine may be responsible for some of the adverse effects reported (Nurminen et al, 1999). As a result of these adverse effects, DMAA has caught the attention of regulatory agencies worldwide, with New Zealand fully removing it from the market in 2012 (Eliason et al, 2012), and the Food and Drug Administration banning its use as an ingredient in dietary supplements in 2013 (Foley et al, 2014). …”

Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series

“…In addition, an updated causality score using the standardized Roussel Uclaf Causality Assessment Method (RUCAM) was calculated for each case and implicated agent by manuscript authors in 2015 (14). By convention, RUCAM scores are grouped into likelihood levels as “excluded” (≤ 0), “unlikely” (1–2), “possible” (3–5), “probable” (6–8) and “highly probable” (> 8). In subjects with 2 or more implicated drugs or HDS products, an overall causality score was assigned to the case and then a causality score was also determined for each individual suspect drug or HDS product.…”

“…In mid to late 2013, over 40 cases of severe acute hepatitis and liver failure were linked to the use of the “Super Thermo” formulation of OxyELITE Pro, primarily amongst individuals residing in Hawaii (5–8). The etiology and risk factors for hepatotoxicity amongst these patients remain under investigation.…”