Doh! Supplements Spiked with Hepatitis

[Flex]

OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use

[Posted 10/08/2013]

AUDIENCE: Health Professional, Consumer

ISSUE: The FDA, along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH), are investigating a growing number of reports of acute non-viral hepatitis in Hawaii. The Hawaii DOH has reported that 24 of these cases share a common link to a dietary supplement product labeled as OxyElite Pro.

BACKGROUND: OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nation-wide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. There have been 29 cases of acute non-viral hepatitis with an unknown cause identified in the state of Hawaii.  Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. CDC is also looking at other cases of liver injury nationwide that may be related. 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.

The epidemiological investigation is being conducted by the Hawaii DOH and the CDC. 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.

RECOMMENDATION: 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.

 

USPLabs Press Release

Oct 8, 2013

 

FOR IMMEDIATE RELEASE

Dallas, TX-October 8, 2013-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 OxyEiite Pro with the Purple Top and OxyEiite 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.

 

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http://www.anabolize.com/index.php/2013/10/c4-and-animal-stack-associated-with-cholestatic-liver-injury/

C4 and Animal Stack associated with Cholestatic Liver injury

This latest study comes to us from the United States Military and their department of pathology. Six cases of cholestatic liver injury were observed at the Naval Medical Center at San Diego. Dietary supplements were considered probable as the root cause for three, probable for one, and possible for another. The attending physicians had seen cases associeted with four of the dietary supplements involved. However, they also noted that two supplements, C4 Extreme and Animal Stak, although implicated in the current work, had not been previously linked to hepatoxicity.

Mil Med. 2013 Oct;178(10):e1168-e1171.

Cholestatic Liver Injury Associated With Dietary Supplements: A Report of Five Cases in Active Duty Service Members.

Peterson BR, Deroche TC, Huber AR, Shields WW.

Source

 

Department of Anatomic Pathology, Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134-5000.

Abstract

The use of dietary supplements (DS) is common in the active duty population, often without physician knowledge or approval. DS have been associated with drug-induced liver injury, with rare cases resulting in liver failure or death. We report five cases of transient drug-induced liver injury temporally associated with the use of a total of six DS in active duty service members. All patients presented with elevated serum bilirubin and liver-associated enzymes: three patients had a cholestatic liver enzyme pattern, one had a hepatocellular pattern, and one had a mixed pattern. In all cases, percutaneous needle core biopsies of the liver were obtained and demonstrated a cholestatic pattern of injury with variable periportal fibrosis. Causality was considered highly probable for three cases, probable for one case, and possible for one case. Hepatotoxicity has been previously associated with four of the supplements in our cases. For the two remaining supplements, C4 Extreme and Animal Stak, we are unaware of any previous reports of hepatotoxicity. Health care professionals, in particular military physicians, should be aware of the potential risk of these supplements and be prepared to discuss these risks with their patients.

 

Reprint & Copyright © 2013 Association of Military Surgeons of the U.S.

[Gym rat]

that sounds very scary

[Pseudonym]

Out of an abundance of caution, the company has ceased domestic distribution of OxyEiite Pro with the Purple Top and OxyEiite Pro Super Thermo Powder until the investigation has been completed.

So, is that a voluntary recall? Or is it just stopping producing any more of the stuff?

I guess, if it's only been found to cause problems in Hawaii, then maybe products have been tampered with? Otherwise you'd expect the problems to be widespread.

[Flex]

Warning over sports supplement

By Morgan Tait http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11145149

5:30 AM Thursday Oct 24, 2013

New Zealanders have been urged not to take a sports supplement linked to dozens of cases of hepatitis - and one death - in the United States.

Fat-burning supplement OxyELITE Pro has been wiped from shelves around the world after the US Food and Drug Administration (FDA) linked it to 29 cases of non-viral hepatitis that resulted in one death and two liver transplants in Hawaii.

New Zealand Ministry for Primary Industries (MPI) yesterday issued a warning advising Kiwis to stay away from the substance that can be bought in powder form on the internet and from some stores.

Acting Director-General Scott Gallacher said the MPI was also investigating one case of the illness here that may be linked to the supplement.

He said MPI was informed of a potential risk last week that was confirmed yesterday.

The products are distributed here by Australian company Flush Fitness and were available on several websites.

Flush Fitness spokesman Nicholas Mercieca said the products sold here were formulated from different ingredients than those under investigation in the United States.

 

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[Gym rat]

There was a article about this topic in the sports section in today Otago daily times which was pretty much the same  article what Flex got off the NZ hearld website.

[jerume]

Yeah I read this in the news the other day, yet our formula in N.Z is different to overseas, so I wonder if our formula is free from these issues? anyone have any ideas on that?

Also while the topic is up about supplements spiked, one of Aucklands bigger supplement companies sell a brand of supplements who's owner is being charged by the FDA for poisoning their own products, who knows why they would want to kill their own profit and brand!

aparently causing the deaths of 3 people overseas.

 

The brand? Profight supplements, the maker of one of my favorite proteins and fat burners,but you cant believe everything you read, so will paste the link and let people make their own mind up.

http://www.ripoffreport.com/r/Pro-Fight-Supplements/various-California-/Pro-Fight-Supplements-Pro-Fight-Supplements-Charged-By-FDA-for-putting-deadly-chemical-f-982425

[Pseudonym]

Seems like maybe New Zealanders have been affected after all...

Sports drink sparks warning after non-viral hepatitis diagnosis

5:46 PM Friday Nov 15, 2013

At least one person has been diagnosed with non-viral hepatitis after consuming a sports drink, prompting a warning from the Ministry for Primary Industries.

The ministry's acting director general Scott Gallacher said he had been advised of one case of non-viral hepatitis and one possible case of non-viral hepatitis in New Zealand in consumers of a drink labelled OxyELITE Power Super T. Genic Caffeinated Beverage.

It follows a warning issued by the US Food and Drug administration not to consume the drink, or a dietary supplement, OxyELITE Pro, which is produced by the same company, USP Labs of Dallas, Texas.

Mr Gallacher advised people to avoid consuming the products, which are sold in New Zealand in sports supplement stores and on the internet.

"There is a potential food safety issue related to both of these products," he said.

The products may be labelled as dietary supplements and/or as caffeinated beverages.

Both cases of non-viral hepatitis were under investigation.

- APNZ