Life-Threatening Liver Toxicity Linked to Supplement

On Oct. 8, 2013, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) 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],[2]

As of early October, 24 patients have been diagnosed with acute hepatitis following their use of OxyELITE PRO.[3] Five other cases of the disease occurred following the use of other dietary supplements.[4] Two patients subsequently needed to undergo liver transplantation, and one died.[5] This outbreak provides another tragic example of the serious harm that can result from consuming poorly regulated dietary supplements.

The center of the outbreak

The outbreak of hepatitis linked to OxyELITE PRO began in Hawaii, and most of the confirmed cases thus far have occurred in that state. The Hawaii Department of Health (HDOH) first became aware of this serious public health threat when it was notified on Sept. 9, 2013, of seven patients who had developed severe acute hepatitis and sudden liver failure of unknown cause.[6] These individuals reportedly were all previously in good health and presented with signs of acute liver disease between May and September 2013.[7] One factor discovered to be common to all seven patients was consumption of OxyELITE PRO.[8]

The initial notification to the HDOH triggered an intensive disease-outbreak investigation by the HDOH, CDC and the FDA, which is ongoing. Government epidemiology investigators first interviewed the initially identified patients, reviewed their medical records and collected samples of the OxyELITE PRO supplement for chemical analysis.[9]

The investigators also sought to identify other patients who may have developed acute liver disease following the use of OxyELITE PRO. To facilitate this search, the HDOH issued a statewide medical advisory to doctors, clinics and hospital emergency departments.[10] The investigators specifically wanted to know about anyone who had been diagnosed with acute hepatitis of unknown cause on or after April 1, 2013, and who had consumed any weight-loss or muscle-building dietary supplement within the 60 days prior to onset of the hepatitis.[11] To be included as an outbreak case, patients had to meet the following criteria:[12]

• evidence of significant liver injury on blood tests (at least a fourfold elevation of the liver enzyme alanine aminotransferase, or ALT, and at least a twofold elevation of bilirubin levels above the upper limits of normal for each);
• negative tests for infections, including viral hepatitis (such as hepatitis A, B or C); and
• no history or evidence of other causes of liver disease, such as chronic alcohol use, autoimmune hepatitis or several types of uncommon chronic liver diseases.

In response to its public health alert, the HDOH received 45 reports of possible cases from health care providers across the state.[13] Overall, 29 — including the initial seven cases reported to the HDOH on Sept. 9 — met the criteria for a case of acute, nonviral hepatitis of unknown cause following consumption of a weight-loss or muscle-building supplement.[14]

Characteristics of the cases

On Oct. 11, the CDC published a report in its Morbidity and Mortality Weekly Report describing the characteristics of the 29 identified cases.[15] The median age of the patients was 33 years (with a range of 16 to 66), and 48 percent were male.[16] The date of illness onset, based on the date of the earliest abnormal blood test results showing liver damage, ranged from May 10 through Oct. 3, 2013.[17] The patients’ most common symptoms were loss of appetite, light-colored stools, dark urine and jaundice (yellow eyes or skin),[18] all of which are typical for liver injury. All patients had markedly abnormal blood liver tests at the peak of their illness severity.[19] Results of liver biopsies were available for 10 patients, and 70 percent of these had changes consistent with drug- or toxin-induced liver injury.[20]

Eleven patients (38 percent) were hospitalized for a median of seven days (with a range of one to 45 days).[21] One patient died, two received liver transplants and two remained hospitalized as of early October.[22]

Twenty-four of the 29 patients (83 percent) reported consumption of OxyELITE PRO within two months prior to onset of the hepatitis.[23] Twelve patients (41 percent) had used only OxyELITE PRO and no other dietary supplement, whereas 12 (41 percent) reported taking both OxyELITE PRO and at least one other dietary supplement.[24] Three patients (10 percent) noted using other weight-loss or muscle-building dietary supplements, but not OxyELITE PRO.[25] For two patients (7 percent), it is currently unknown whether they used OxyELITE PRO.[26]

Finally, for 12 patients, the duration of use of OxyELITE PRO prior to developing symptoms of acute hepatitis was known. For these cases, the median duration of use prior to illness was 60 days, with a range of seven to 130 days.[27]

Nationwide search for cases

The CDC has indicated that efforts are under way to identify other cases across the U.S. The agency has surveyed poison control center data that are collected in the National Poison Data System (NPDS),[28] which contains information from the human poison exposure case phone calls taken by all 56 poison centers across the country.[29]

The CDC also alerted representatives of U.S. transplant centers through the United Network for Organ Sharing (UNOS) to see if they had seen any cases of liver failure that may be linked to use of OxyELITE PRO.[30] UNOS maintains and operates a national waiting list for organ donation and matches organ donors to patients awaiting organ transplants.[31] The organization also maintains a database containing information on every transplant carried out in the U.S., including liver transplants.

Through these national search activities, the CDC so far has identified four cases of acute hepatitis diagnosed outside of Hawaii linked to the use of OxyELITE PRO or some other weight-loss or muscle-building dietary supplement.[32] One of these four patients is a resident of Hawaii who bought the dietary supplement in Hawaii but was diagnosed in another state.[33] The CDC continues to work with officials in the relevant state health departments to investigate these cases to determine if this outbreak is actually a nationwide public health problem.

The source of OxyELITE PRO

The FDA reported that OxyELITE PRO is distributed by USPlabs LLC in Dallas, Texas.[34] The product is usually sold throughout the nation via the Internet and retail stores that sell dietary supplements, but[35] the company has voluntarily suspended distribution of the products in the U.S. while the investigation of the hepatitis cases is ongoing.[36] The HDOH also requested that local retailers voluntarily discontinue sale of OxyELITE PRO pending completion of the ongoing investigation.

The FDA is conducting tests on samples of OxyELITE PRO that had been used by some of the patients who developed hepatitis to determine the chemical composition of the products.[37] Results of these tests are not yet available. It is likely that the dietary supplements linked to the hepatitis cases will be found to be laced with some drug, herb or other substance known to be toxic to the liver. The FDA also is inspecting company facilities where the product is manufactured.[38]

At the time of the outbreak, USP-labs was distributing two specific products under the OxyELITE PRO brand name: OxyELITE PRO “with the purple top” and OxyELITE PRO SUPER THERMO POWDER.[39] The company previously sold OxyELITE PRO WITH DMAA, but this product — which contained the chemical dimethylamylamine (DMAA) — has not been manufactured or distributed by the company since early 2013[40] (probably in response to a 2012 FDA warning letter issued to the company finding that this was not a legal dietary supplement[41]). DMAA has amphetamine-like properties and has been described by the FDA as “known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack.”[42]

According 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 these allegations, the FDA is evaluating whether any of the cases of acute hepatitis are related to counterfeit OxyELITE PRO products.[43]

What You Should Do

If you are using any dietary supplement product labeled OxyELITE PRO, stop using it immediately.

If you are using or have recently used OxyELITE PRO or any other weight-loss or muscle-building dietary supplement, 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, and clay- or grey-colored bowel movements.

Finally, Worst Pills, Best Pills News recommends against using any dietary supplements for weight loss or bodybuilding. For more information, read “Dietary and Herbal Supplements” at WorstPills.org.

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] Centers for Disease Control and Prevention. Acute hepatitis and liver failure following the use of a dietary supplement intended for weight loss or muscle building. October 8, 2013. http://emergency.cdc.gov/HAN/han00356.asp. Accessed October 11, 2013.

[3] 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.

[4] Centers for Disease Control and Prevention. Acute hepatitis and liver failure following the use of a dietary supplement intended for weight loss or muscle building. October 8, 2013. http://emergency.cdc.gov/HAN/han00356.asp. Accessed October 11, 2013.

[5] Ibid.

[6] 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.

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Hawaii Department of Health. News Release: Department of health investigates hepatitis, liver failure in persons taking diet supplements. September 26, 2013. http://health.hawaii.gov/news/files/2013/05/13-055-Department-of-Health-Investigates-Hepatitis-Liver-Failure-in-Persons-Taking-Diet-Suppliments.pdf. Accessed October 11, 2013.

[11] 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.

[12] Ibid.

[13] Ibid.

[14] Ibid.

[15] Ibid.

[16] Ibid.

[17] Ibid.

[18] Ibid.

[19] Ibid.

[20] Ibid.

[21] Ibid.

[22] Ibid.

[23] Ibid.

[24] Ibid.

[25] Ibid.

[26] Ibid.

[27] Ibid.

[28] Ibid.

[29] American Association of Poison Control Centers. National Poison Data System. http://www.aapcc.org/data-system/. Accessed October 11, 2013.

[30] 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.

[31] United Network for Organ Sharing. About us. http://www.unos.org/about/index.php. Accessed October 11, 2013.

[32] 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.

[33] Ibid.

[34] 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.

[35] Ibid.

[36] The Food and Drug Administration. FDA investigates acute hepatitis illnesses potentially linked to products labeled OxyElite Pro. What is the problem and what is being done about it? Posted October 11, 2013. http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm370849.htm. Accessed October 11, 2013.

[37] Ibid.

[38] Ibid.

[39] The Clark Firm. USPLabs issues statement on OxyElite Pro hepatitis epidemic. http://www.theclarkfirmtexas.com/usplabs-issues-statement-on-oxyelite-pro-hepatitis-epidemic. Accessed October 11, 2013.

[40] Ibid.

[41] The Food and Drug Administration. Warning Letter to USP Labs LLC. April 24, 2012. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm302167.htm. Accessed October 11, 2013.

[42] The Food and Drug Administration. FDA news release: FDA challenges marketing of DMAA products for lack of safety evidence. April 27, 2012. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm302133.htm. Accessed October 25, 2013.

[43] 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.