Cause of liver failure outbreak remains open

Alerted late last month to a likely link between several cases of liver failure and the use of dietary supplements, doctors in Hawaii have since reported roughly two dozen more suspected cases from the past six months, the state’s epidemiologist said.

The onset of the most recent case came just days before a warning from the state Department of Health on Sept. 26, but Dr. Sarah Park said no new cases have developed since then. The number of suspected cases is now in the 30s.

Still, Park cautioned this week against calling an end to the alarming outbreak of acute liver inflammation and liver failure that might have been triggered by the desire to lose weight and/or gain muscle.

"I think it’s too early to say where we’re going right now," she said.

Despite the spike in cases to investigate, officials are still stumped as to what precisely caused otherwise healthy adults with no apparent risk factors to rapidly fall ill while taking a dietary supplement. It is also unclear why the cases seem to be coming only from Hawaii.

Park reiterated the department’s reluctance to name any products that may be suspected because "it may not be as simple as that."

She added, "We can’t afford to focus in and say, ‘You know, it’s this product,’ because for all we know there could be an ingredient that’s common to multiple products. Maybe it was a bad lot and that lot’s gone — I don’t know; but we can’t be sure."

She said it also could be that the dietary supplement reacted poorly with other supplements also being taken, such as energy drinks, protein powder or vitamins.

In early September the Star-Advertiser spoke with a liver transplant surgeon at the Queen’s Medical Center who said the product OxyElite Pro in its original formula was the suspected cause for at least five acute liver failure cases that cropped up over the summer. The supplement is marketed as a fat-burner.

Hawaii News Now reported Wednesday that a 48-year-old Maui mother of seven is in a medically induced coma at Queen’s after she took the diet product and became violently ill.

Of the seven cases of extreme liver failure that prompted the public alert, Park said three people recovered on their own, two have received liver transplants, another is being evaluated for transplant and a woman is "expected to pass any time now because she’s not a transplant candidate."

She added, "You can’t survive without your liver, and if your condition progresses, I mean, you’re just fatal. To have someone in the prime of their life struck down like this is just devastating."

The producer of the OxyElite Pro supplement, USPlabs, told the Star-Advertiser on Thursday that the company had not yet been contacted by officials regarding any dangers linked to the product.

"We know of no credible evidence linking OxyElite Pro to liver issues," the company said via email. "At this point anything to the contrary is just speculation. The company has not yet been contacted by the Hawaii Department of Health regarding this issue. We stand by the safety of our product, which has a strong safety history and scientific support."

The original formula of OxyElite Pro included the ingredient DMAA, which the U.S. Food and Drug Administration banned for use in dietary supplements in April 2012.

The FDA had received 86 reports of illnesses or death associated with supplements containing DMAA since 2008, including heart problems and nervous system or psychiatric disorders.

The FDA in April issued a warning updating consumers that it was "using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace."

According to that warning on the FDA.gov website, all but one of the producers of DMAA products agreed to stop using the ingredient.

"The one company that has yet to agree to such action, USPlabs, has responded to the FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions," the warning says. "However, after reviewing the studies provided by USPlabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements."

The New York Times reported in June that USPlabs soon after agreed to stop making DMAA products for business reasons, but the company continued to distribute its remaining stock, worth about $8 million. The FDA later told the Times that USPlabs destroyed all remaining stock at a company warehouse in Dallas on July 2.

Park confirmed Thursday that the Health Department has not contacted USPlabs regarding OxyElite Pro.

"We haven’t fingered a product, so why would we talk to a company?" she said. "Plus, we don’t regulate the products, FDA (does), so that’s not up to us."

Park said the department continues to work with the FDA to find a cause for the liver problems, but efforts have slowed due to the federal government shutdown that began Tuesday.

"Our federal partners are feeling an effect, and therefore we are feeling an effect," she said. "I do think that this federal shutdown is impacting us."

FDA spokes­woman Shelly Burgess, who previously provided the Star-Advertiser with a comment acknowledging the investigation, was not able to respond this week. An auto-response said, "Due to the absence of either an FY2014 appropriation or Continuing Resolution for the Department of Health and Human Services, I am out of the office on furlough and cannot respond to your email."

The state health department is having trouble coming up with a cause in part because getting in touch with patients who have overcome their illness has been difficult, Park said. Some who were located disposed of the product or products they were taking.

"Then it’s hearsay, and without that product to do the testing … it makes it that much harder," she said. "It’s like trying to put together a puzzle and all you have (is) maybe two pieces out of a 100-piece set."