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WARNING: FDA recall on OxyElite Pro due to connection with “serious adverse health consequences, namely serious liver damage or acute liver failure”

Posted in Public Health, Recalls

On 11-9-2013, the FDA announced a recall of dietary supplement OxyElite Pro (USPlabs LLC, Dallas) “after officials linked it to cases of liver failure and acute hepatitis in 29 people” in Hawaii, CNN reports.

Several sources now report that one of two patients who required liver transplants has died.  WebMD writes that other people “are awaiting liver transplants in connection with the supplements, which are used for weight loss.”

Due to the fact that OxyElite Pro is classified as a “dietary supplement,” not a drug per se, FDA approval for the compound was not required.  WebMD continues, stating “The FDA sent a warning letter to USPlabs last month telling the company they must stop distributing OxyElite Pro and another dietary supplement, VERSA-1.The supplements contain the ingredient aegeline. The FDA says the ingredient ‘lacks history of use or other evidence of safety.’”

“In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking.” (Outbreaks > FDA Investigates Acute Hepatitis Illnesses Potentially Linked to Products Labeled OxyElite Pro)

 

The FDA writes “Epidemiological evidence shows that use of these products has been associated with serious adverse health consequences, namely serious liver damage or acute liver failure, concentrated in Hawaii.  Investigations are ongoing into a potential causal relationship.  [USPlabs, LLC] agrees with FDA that a national recall is appropriate as a precautionary measure. Product was distributed nationwide through retail stores, mail orders and direct delivery.”

Here is a list of products subject to this OxyElite Pro recall:

“OxyElite Pro Super Thermo capsules

2 count capsules UPC #094922417275

10 count capsules UPC #094922417251

10 count capsules UPC #094922417268

21 count capsules UPC #094922426604

90 count capsules UPC #094922395573

90 count capsules “Pink label” UPC #094922447906

180 count capsules UPC #094922447852

OxyElite Pro Ultra-Intense Thermo capsules

3 count capsules UPC #094922447883

3 count capsules UPC #094922447876

90 count capsules UPC #094922395627

180 count capsules UPC #094922447869

OxyElite Pro Super Thermo Powder

Fruit Punch 0.15 oz UPC #094922417237

Fruit Punch 0.15 oz UPC #094922447517

Fruit Punch 4.6 oz UPC #094922426369

Fruit Punch 5 oz. UPC #094922447487

Blue Raspberry 4.6 oz UPC #094922426376

Grape Bubblegum 4.6 oz UPC #094922447500

Green Apple 4.6 oz. UPC #094922426499”

FDA on symptoms of acute hepatitis:

“Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice.”

If you or someone you know has purchased OxyElite Pro, stop using the product immediately, and advise loved ones to do the same.  The FDA states that one can “return it to where [one] purchased it for a refund.”  If you or a loved one experienced adverse effects while taking OxyElite Pro, contact your health care professional or go to the nearest emergency room.