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FDA issues health advisory for OxyElite Pro due to possible link to liver damage

OxyElite Pro pulled from shelves while investigation continues
OxyElite Pro pulled from shelves while investigation continues
USLabs LLC

The weightloss product OxyElite Pro and its makers USPlabs LLC of Dallas, Texas are currently under investigation by the FDA, CDC and the state of Hawaii's Department of Health for a possible link to liver damage after consuming the weightloss product.

Therefore, in a FDA health Alert dated October 8th, 2013, health officials are recommending consumers discontinue use OxyElite Pro while the investigation continues. The supplement is is sold nation-wide through retail stores that sell dietary supplements and online stores and auction sites including ebay.

In an official statement from USPlabs, they say "The company stands by the safety of all of its products. The company is cooperating with FDA on reports coming out of Hawaii. The cluster of liver issues in Hawaii is a complete mystery and nothing like this has ever been associated with OxyELITE Pro in all of the years our products have been in the market. We know of no credible evidence linking OxyELITE Pro to liver issues. The ingredients have been studied for safety, are consumed in the food supply and widely used in dietary supplements. The studies and consumption history show no negative liver issues. Due to multiple products within the OxyELITE Pro brand, it may be confusing as to which products are being looked at. The specific products are the original OxyELITE Pro with DMAA, OxyELITE Pro with the “Purple Top” and OxyELITE Pro Super Thermo Powder. The original version with DMAA has not been manufactured or distributed since early 2013. Out of an abundance of caution, the company has ceased domestic distribution of OxyElite Pro with the Purple Top and OxyElite Pro Super Thermo Powder until the investigation has been completed. The company continues to believe these versions are safe and are not the cause of the cluster of liver toxicity that has occurred in Hawaii."

Experts say there have been 29 cases of non-viral hepatitis reported so far in Hawaii only. Of the 29 cases reported, 24 of them have the common denominator of using OxyElite Pro. The CDC tells us that from the 29, 11 have been hospitalized for hepatitis symptoms, 2 needing a liver transplant, and one leading to death due to the fact that she was not eligible for a liver transplant because she also had breast cancer. However, they don't tell us if all of those extreme cases are part of the 5 that did not consume the product in question. Health experts have not yet pinpointed the exact way the diet pills could have spurred these effects. Nor can they tell us why these cases are only appearing in Hawaii and not nationwide. So it is a bit inconclusive at this point.

Oddly enough, according to the product label, none of the ingredients are typical of extreme adverse health concerns or warnings, and in fact according to label disclosures, the supplement formula has been developed by pharmacology experts and have been studied and scientifically proven. Nonetheless, industry insiders claim that actual ingredients don't always match up to product labels. Hence, the FDA will be analyzing product samples as well.

According to the FDA health alert, "As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients. Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis."

Again, sellers are being urged to stop selling and consumers are being urged to stop using any product labeled OxyPro Elite while the investigation continues. Consumers should know that 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.

Also according to the health alert, "Healthcare professionals and patients 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:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

http://www.ncbi.nlm.nih.gov/pubmed/23602053

http://www.ncbi.nlm.nih.gov/pubmed/21036583

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...