The manufacturer of OxyElite Pro — the dietary supplement responsible for causing the death of a Maui woman and liver damage among more than 30 Hawaii residents — has recalled certain products under threat from the Food and Drug Administration.
The move came Saturday after the FDA sent the company a letter saying it believes there is a reasonable probability that the products are adulterated and related to the Hawaii incidents as well as a growing number of cases nationwide.
The letter, sent to USPlabs LLC of Dallas on Wednesday, also notified the company that the agency could order it to stop distributing the dietary supplements if it chose not to initiate a voluntary recall.
According to an FDA news release Sunday, the products involved in the recall include OxyElite Pro Super Thermo and OxyElite Pro Ultra-Intense Thermo capsules as well as varieties of OxyElite Pro Super Thermo Powder. UPC numbers are listed on the FDA’s website.
The FDA has been working with the Centers for Disease Control and Prevention and state and local health officials to investigate a rash of nonviral hepatitis or liver damage and liver failure cases that could only have been caused by consuming a dietary supplement.
As of Oct. 31, 56 cases had been identified by the agency. Twenty-two of those people were hospitalized, two received liver transplants and a Maui woman died.
The FDA said it reviewed 46 sets of medical records submitted by the state Department of Health and found that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro before becoming sick. OxyElite Pro was the only dietary supplement consumed by 17 of the 27 patients, or 63 percent, the FDA said.
The manufacturer also received a warning letter from the FDA on Oct. 11, telling it to stop distribution of OxyElite Pro and VERSA-1 because the FDA discovered they contain aegeline, an herbal extract that doesn’t have a history of use in the U.S. or evidence of safety.
State Department of Health officials recently ruled out that Hawaii got a bad batch of dietary supplements sold under the OxyElite Pro brand name because there was no common lot number among patients, and lot numbers associated with patients here were distributed elsewhere around the country, Dr. Sarah Park, state epidemiologist, said last week.
Officials are still stumped, however, as to what specifically about the product caused dozens of isle residents to get sick.
"It can’t be something that’s unique to Hawaii, and I think that’s being borne out as the CDC is finding further cases on the mainland," Park said.
Park theorized that Hawaii’s relatively small health care system — with the Queen’s Medical Center being the only liver transplant center in the isles — helped bring the issue to light here much faster.