Saturday, October 12, 2013

NBC12 Video: Oxy-Elite Pro sold in major retail stores all over the US

OxyELITE Pro user shares experience with liver problems 
Update: FDA investigates Hawaii outbreak of non-viral hepatitis - Richmond, VA News

A startling investigation on a diet pill that's under a lot of heat right now after more than 2 dozen people were sent to the hospital and one person even died - possibly from taking it.

It's called Oxy-Elite Pro, and it's sold in major retail stores all over the US. This drug has now been removed from store shelves in some parts of the country - but not in the commonwealth.

There have been 29 cases of acute hepatitis, liver failure and even the death of one woman - all in Hawaii.

"It is time to take more formal action," said Loretta Fuddy, Director of the State Department of Health, Hawaii.

GNC stores are a major carrier of the drug. They've pulled it from store shelves in Hawaii and say it's no longer available on line.

But here at this GNC in Chesterfield it's still marked $59.99 for a bottle; that's because, not all stores are required to take it down just yet.

"Anything that you take that your body doesn't naturally produce your liver has to process so it's going to cause some toll on it to one degree or to say they died because of this product is rather an ambiguous statement," said GNC sales rep, Jerry Maitland.

The question remains, did Oxy-Elite Pro cause liver failure, and death. The CDC and the FDA are trying to figure that out.

ACSM Health and fitness specialist, Maria Beall says this is a major concern.

"You have to be careful when products are not FDA approved, first of all, any label can claim anything, so you have to be your own advocate," said Beall.

Here is the press release from USPlabs:

"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."

The FDA released the following recommendations:
The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

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:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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