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State Department of Health officials in the past week have identified five more cases of liver damage that could have been caused by consuming a dietary supplement — bringing the current total to 34.
As with previous case counts released by the department, the state’s epidemiologist said Thursday that all of the patients developed their symptoms from May through September.
"For now, knock on wood, the good news is that all the onsets for all the cases occurred or began pretty much before we first came out with our news release and my medical advisory to the clinicians," Dr. Sarah Park said.
The department first went public with its concerns Sept. 26.
Park, state epidemiologist, said finding out about past cases within the May-September time frame is still helpful because "the more data that we have, hopefully, the more helpful that will be in trying to figure out what’s going on."
Beyond pegging OxyELITE Pro and possibly other supplements as culprits, state and federal officials looking into the liver damage cases are still unsure as to the precise cause of the alarming epidemic that has landed 15 people in the hospital, led to two liver transplants and caused the death of Sonnette Marras, a 48-year-old Maui mother of seven.
More than 24 of the 34 patients were using OxyELITE Pro products before developing symptoms, Park said, noting that her staff is still going over medical records to determine definitively how many of the five people in the newly reported cases were using the supplement.
Park said the department continues to collaborate closely with the Centers for Disease Control and Prevention and the Food and Drug Administration to determine whether Hawaii received a bad batch of the supplements or whether any number of other factors could be to blame.
"We’re waiting on further information, especially product information from FDA, so hopefully down the line, when we are able to sort out all the information, we’ll have a better picture," she said. "It’s all very challenging."
With the federal government reopened Thursday, the FDA was able to respond to a previous request from the Honolulu Star-Advertiser for comment. A spokeswoman for the administration, however, said the agency typically does not discuss ongoing investigations.
The FDA and CDC on Oct. 8 notified the public and physicians that cases of liver damage in Hawaii were linked to OxyELITE Pro products. At that time the state requested that local retailers stop selling the product during the investigation.
The next day that request became a mandate.
On Oct. 11 the FDA advised consumers against using an additional dietary supplement, VERSA-1, produced by the same manufacturer of OxyELITE Pro.
A common ingredient in the products, aegeline, has not been safety-tested for human consumption or marketed as a lawful dietary supplement ingredient in the U.S., the FDA told Dallas-based USP Labs in a letter sent to the supplement maker.
Park said the FDA hasn’t yet told the state whether to consider aegeline as a likely cause of the Hawaii cases.
"We’re not specifically looking at that product or even that ingredient," she said, noting that the FDA is reviewing the cases and products in question "with a fine-toothed comb" and likely is uncovering information not necessarily associated with the Hawaii investigation.
Why Hawaii seems to be taking the brunt of the outbreak remains a mystery.
A nationwide call from the CDC for liver damage cases linked to dietary supplement use returned four patients outside of Hawaii. One happened to be a Hawaii resident who bought the product here but fell ill in a different state.
"CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these persons to determine if this outbreak is nationwide," the agency said in an Oct. 11 post on its website. It noted, however, that "attributing liver injury to a specific ingredient can be challenging because of multiple ingredients, product variability, and lack of testing to confirm exposure to a product."
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