1 death, 2 liver transplants with non-viral hepatitis linked to OxyElite Pro
On October 8, 2013, the FDA issued a Health Advisory for OxyElite Pro because of acute hepatitis illness cases linked to the product’s use. OxyElite Pro is a product marketed as a dietary supplement and distributed by USPlabs, LLC of Dallas, Texas. The FDA, the CDC and the Hawaii Department of Health (HDOH) are investigating a growing number of reports of non-viral hepatitis in Hawaii. The Hawaii DOH has reported that 24 of these cases share a common link to the dietary supplement product labeled as OxyElite Pro.
The FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis because USPlabs has informed the FDA that counterfeit versions of OxyElite Pro are being marketed in the US and have been on the market for some time.
Background:
OxyElite Pro is sold nation-wide through a wide range of distribution channels, including retail stores and the internet. The FDA reported that there have been 29 cases of acute non-viral hepatitis with an unknown cause identified in Hawaii. Eleven of these individuals have been hospitalized, two have received liver transplants and one person has died. The CDC is also looking at other cases of liver injury nationwide that may be related.
Prior FDA actions regarding OxyElite Pro:
The FDA has issued warning letters to USPlabs, LLC in Dallas, Texas regarding OxyElite and a similar product called Jack3D previously. You can read more about the FDA’s warning to USPlabs, LLC regarding its use of an ingredient called DMAA by clicking here. Health concerns regarding this additive and the marketing strategy of USPlabs regarding this additive were called into question by the FDA. The company was ordered to stop its use of DMAA in its products. A second letter by the FDA can be read here.
Symptoms of hepatitis:
Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes and jaundice.
FDA Recommendations:
Stop using OxyElite Pro while the investigation continues. If you believe that you have been injured by using a dietary supplement, contact your health care practitioner. Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.
Legal Rights:
If you have lost a loved one or have been injured in connection with the use of OxyElite Pro, please consider contacting the Law Offices of John David Hart at 1-800-247-1623 or click here to go to our contact us page to learn about your potential legal rights and remedies. Also, you can email Mr. Hart at johnhart@hartlaw.com. There is no charge for the initial consultation and you are under no obligation to retain the firm. We represent individuals throughout the United States in cases involving dangerous drugs and dangerous medical products.
Click here to read FAQs regarding this product.
Read more about the health advisories issued by government agencies:
For the FDA health advisory, click here.
For the CDC health advisory, click here.
For the Hawaii Department of Health advisory, click here.