A woman from Cleveland Ohio was hospitalized after taking OxyElite Pro. A dietary supplement is apparently designed to increase your fat-burning speed.
The Ohio woman started taking OxyElite Pro dietary supplement pills in June in an attempt to drop weight faster in addition to clean eating and exercising. She took around 4-10 pills per week. In September, she began to feel tired and used the supplements for a quick energy boost. Over the next two months, she became increasingly ill, showing signs of frequent nausea and jaundice.
Eventually, a friend took her to the hospital in early November, where her liver damage was attributed to the use of OxyElite Pro. The Cleveland woman is currently under medical evaluation to determine if the side effects of the supplement require further action or treatment. According to doctors at University Hospitals Case Medical Center, about 30 percent of patients with this kind of extensive liver damage from supplement use require a transplant or die from liver damage. (November, 2013 http://www.cleveland.com/healthfit/index.ssf/2013/11/cleveland_woman_hospitalized_w.html)
The History of OxyElite Pro
OxyElite Pro is a dietary supplement designed to increase fat-burning speed. The pills have a long history of unhealthy side effects. In the summer of 2013, the manufacturers of OxyElite, Dallas-based USPlabs LLC., recalled an earlier version of OxyElite containing dimethylamylamine (DMAA). Two soldiers taking the supplements died from heart attacks after exercise.
Over the last several months, over 50 cases have been brought against the supplement manufacturer involving liver damage and hepatitis (47 in Hawaii). Two cases resulted in the need for a liver transplant, while another case led to the death of the patient.
FDA Sends Letter Regarding OxyElite Pro
The Food and Drug Administration (FDA) responded to these cases by sending a letter to the manufacturers of OxyElite Pro on Oct. 11, 2013 suggesting that all OxyElite Pro products be destroyed. The manufacturers have agreed to destroy the supplements in light of health concerns.
The FDA found that OyxElite Pro, and a similar product by the same manufacturer, VERSA-1 contain aegeline, for which the manufacturers did not offer any evidence of safety. The FDA has recommended that consumers avoid OxyElite Pro, VERSA-1, and any other supplement containing DMAA and aegeline. Possible complications of these ingredients include heart attacks, seizures, liver damage, psychiatric disorders, jaundice, hepatitis, and death.
FDA Supplement Laws and Regulations
Current FDA regulations do not require that supplement manufacturers provide proof of safety or effectiveness of their products to the FDA. However, they must include a label stating that the FDA has not proven the effectiveness of the product, and they must notify the FDA about any new ingredients added to products. Companies must also provide proof that the supplement is safe to ingest. Any ingredient not marketed before Oct. 15, 1994 is considered new. USPLabs did not notify the FDA of their inclusion of DMAA or aegeline.
The FDA has stated that anyone currently taking OxyElite Pro, VERSA-1, or any other supplement with aegeline or DMAA stop immediately, and visit a health professional for a physical evaluation to check for damaging effects of the supplement. (November, 2013 http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm370849.htm)