DO NOT USE WEIGHT-LOSS DIETARY SUPPLEMENT LABELED AS OXYELITE PRO

October 17, 2013

On Oct. 8, 2013, the Food and Drug Administration (FDA) alerted health care providers and consumers about an outbreak of acute nonviral hepatitis (liver inflammation) and liver failure in previously healthy individuals linked to the use of OxyElite Pro, a dietary supplement marketed for weight loss and muscle building.[1]

OxyElite Pro is distributed by USPlabs LLC in Dallas, Texas. It can be purchased online and nationwide in retail stores that sell dietary supplements.[2]

Between May 10 and Oct. 3, 2013, 29 people living in Hawaii were diagnosed with acute hepatitis following use of a dietary supplement for weight loss or muscle building. Of these, 24 were using OxyElite Pro. The most commonly reported symptoms by affected patients were loss of appetite, light-colored stools, dark urine and jaundice (yellow eyes or skin), all of which are typical in hepatitis. Eleven of the 29 patients were hospitalized. Two patients subsequently needed to undergo liver transplantation, and one died.[3]

A nationwide search is under way to identify other cases of acute hepatitis linked to use OxyElite Pro or other weight-loss or muscle-building dietary supplements outside of Hawaii. So far, the Centers for Disease Control and Prevention have identified four cases in other states.[4]

The FDA is conducting chemical analyses of samples of OxyElite Pro products used by some of the affected patients, but results are not available. The agency is also inspecting facilities where the supplements have been manufactured.[5]

According to the FDA, USPlabs informed the agency that the company believes counterfeit versions of OxyElite Pro have been on the U.S. market for some time. In response to the company’s allegations, the FDA is evaluating whether any of the recent cases of acute hepatitis are related to counterfeit OxyElite Pro products.[6]

What You Can Do

If you are using any dietary supplement product labeled as OxyElite Pro, you should stop using it immediately.

If you are using or have recently used OxyElite Pro or any other weight-loss or muscle-building dietary supplement, you should seek immediate medical attention if you experience any of the following symptoms that can occur with hepatitis: yellow eyes, yellow skin, fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, or clay- or grey-colored bowel movements.

Finally, WorstPills.org recommends against using dietary supplements for weight loss or body-building.

To read the FDA’s safety alert, see http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370857.htm.

References

[1] The Food and Drug Administration. OxyElite Pro: Health advisory - acute hepatitis illness cases linked to product use. October 8, 2013. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370857.htm. Accessed October 11, 2013.

[2] Ibid. [Note: Footnote is for entire paragraph]

[3] Ibid. [Note: Footnote is for entire paragraph]

[4] Park SY, Viray M, Johnston D, et al. Acute hepatitis and liver failure following the use of a dietary supplement intended for weight loss or muscle building —May-October 2013. MMWR. 2013; 62(40): 817-819. http://www.cdc.gov/mmwr/pdf/wk/mm6240.pdf

[5] The Food and Drug Administration. OxyElite Pro: Health advisory - acute hepatitis illness cases linked to product use. October 8, 2013. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370857.htm. Accessed October 11, 2013.

[6] Ibid. [Note: Footnote is for entire paragraph]