Diet supplement manufacturer USPLabs is stopping nationwide distribution of the diet pill OxyELITE Pro in lieu of a staggering number of liver failure cases associated with the supplement, Hawaii News Now reported.
The announcement comes shortly after the Hawaii Department of Health requested the “voluntary removal” of OxyELITE Pro from Hawaii retailers, and asked the public to stop any use of the diet supplement. Hawaii DOH linked OxyELITE Pro to 24 recent cases of liver damage across the state, including one death.
A total of twenty nine cases of liver failure and acute hepatitis have been reported in Hawaii in the last six months, all of them linked to dietary supplements. The Department of Health had been reluctant to pinpoint any specific supplement in the past, but now acknowledges that at least 24 of the patients reported using OxyELITE Pro before being hospitalized.
“No other supplement or medication has been identified in common among more than two patients,” Dr. Sarah Park, the state epidemiologist, said in a statement.
The FDA warned earlier this year against supplements containing dimethylamylamine (DMAA), including OxyELITE Pro, after it was linked to cases of serious illness and even deaths. However, OxyELITE Pro said in a statement that the "original version with DMAA has not been manufactured or distributed since early 2013."
OxyELITE Pro was sold all over the United States, but all of the known recent hospitalizations have occurred in Hawaii. However, health experts have not yet pinpointed the exact way the diet pills could have spurred these effects.
A 48-year-old mother of seven died last week after taking OxyELITE Pro, Hawaii News Now reported. According to her family, Sonnette Marras started taking the pills to lose weight but after just a short amount of time, felt severely ill. She was put into a medically induced coma and required a liver transplant, but was deemed ineligible after doctors discovered she had breast cancer.
USPLabs issued a statement regarding OxyELITE Pro regarding the cases:
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.