OxyElite Pro Recall 2013: Hepatitis, Liver Failure Cited In HHS Probe

OxyElite Pro
OxyElite Pro, a fat burning supplement, has been linked to 29 cases of non-viral hepatitis in Hawaii. oxyelitepro.com

Following a string of reports of liver failure and hepatitis infections, the Food and Drug Administration (FDA) has advised a Texas-based manufacturer to recall all OxyElite Pro weight-loss supplements and destroy warehouse inventory valued at $22 million, department officials said in a statement released Monday.

Earlier this month, USPlabs LLC of Dallas, Tex. came under federal scrutiny after the link between OxyElite Pro and liver complications was brought to the attention of several Health and Human Services (HHS) departments. According to Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA, the bulk of the investigation took place in Hawaii, where as many as 24 people may have contracted acute hepatitis as a result of using the weight loss supplement.

"As soon as we suspected a possible link between OxyElite Pro products and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC)," he said in a press release. "Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace."

In a health advisory release in early October, the FDA recommended that the public stop using any product labeled as OxyElite Pro and contact their healthcare practitioner if they suspected harm. At the time, OxyElite Pro had been implicated in 24 cases of acute non-viral hepatitis. One of these patients later died from acute liver failure, and several others required liver transplants.

According to officials, USPlabs has a history of stretching regulations set forth by the FDA. Earlier this year, the company was ordered to destroy a stockpile of a specific formulation of OxyElite Pro after it was revealed that it contained the stimulant dimethylamylamine (DMAA). In October, the company received a second warning for substituting aegeline — a synthetic alkaloid that the FDA classifies as an adulterant.  "Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law," Fabricant told reporters. "Losses to the company should also serve as a reminder that FDA's laws and regulations serve a purpose and must be followed."

Anyone who suspects that OxyElite Pro may have affected their liver should contact their physician and file an online report here. Relevant symptoms include fever, fatigue, nausea, vomiting, dark urine, joint pain, yellow eyes, and jaundice. 

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