USPLabs, the manufacturer of the diet supplement called OxyELITE Pro, has halted distribution of the drug nationwide following multiple cases of liver failure linked to the supplement discovered by the Hawaii Department of Health. The Hawaii Department of Health requested a voluntary removal of the supplement from store shelves across the state of Hawaii. It also asked the public to stop any use of the diet supplement.
Dietary supplements have been directly linked to 29 cases of liver failure and acute hepatitis in Hawaii within the past six months. Of those 29 cases, at least 24 were among patients who reported taking the OxyELITE supplement. One case has resulted in death.
Even though OxyELITE Pro had been sold all over the United States, all of the known hospitalizations and deaths from the supplement have taken place in Hawaii. It is possible that a bad batch was sold in Hawaii. Another reason could be exposure to heat, which has been known to alter pills’ effects.
“No other supplement or medication has been identified in common among more than two patients,” said Dr. Sarah Park, Hawaii’s state epidemiologist, in a Huffington Post article.
The request by the Hawaii Department of Health to remove OxyELITE Pro from all store shelves in Hawaii resulted in almost unanimous compliance among retailers across the state. One store, however, said no.
“GNC uniformly informed us there were not going to remove it,” said Gary Gill, Hawaii Deputy Director of Environmental Health, in another news article.
The U.S. Food and Drug Administration issued a ban earlier this year against supplements containing dimethylamylamine (DMAA). This includes OxyELITE Pro. However, USPLabs has reported that the original version of OxyELITE Pro containing DMAA has not been manufactured and distributed since early 2013.
An investigation into the product by the Hawaii State Department of Health is ongoing. The department is working with the FDA and Centers for Disease Control and Prevention. If the results of the investigation prove that the supplement is a health risk because of its formula or as a result of an contamination, the Department of Health will “seize and destroy” the supplement.