Dietary Supplement Alert: Hawaiʻi Cases Climb to 29, 1 Death

October 8, 2013, 11:07 AM HST · Updated October 8, 11:33 AM
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By Wendy Osher

Package photo released by the company.

Package photo released publicly by the company.

The Hawaiʻi Department of Health issued an alert today requesting the voluntary removal of the dietary supplement OxyElite Pro from local store shelves.

The request was made pending, “an ongoing investigation of cases of liver failure and acute hepatitis,” that state health officials say may be related to the use of diet supplements for weight loss and/or muscle building.

The alert comes as state health officials investigate 29 cases of acute hepatitis and liver failure that have occurred in Hawaiʻi between May and October.

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The cases under investigation reportedly include two individuals that have undergone liver transplants and one death, according to information released today by the department.

State Epidemiologist Dr. Sarah Park said 24 of the 29 cases reported using OxyElite Pro before their illness. “No other supplement or medication has been identified in common among more than two patients,” said Dr. Park in a department-issued press release.

An initial advisory was issued by the state DOH in September, but authorities at the time did not identify a specific product in association with their findings.

The Food and Drug Administration also issued a safety alert today saying the investigation, in coordination with the Hawaiʻi DOH and Centers for Disease Control and Prevention, is looking into “a growing number of reports of acute non-viral hepatitis in Hawaiʻi.”

The DOH began notifying retailers and distributors today to voluntarily suspend sales and remove the product from store shelves until further notice, state health officials said.

The public is also advised to discontinue use of the product at this time, according to health officials.

“The department continues to urge people who use dietary or nutritional supplements for weight loss and/or muscle gain to talk with their doctor or health care provider,” said Health Director Loretta Fuddy in a statement.

The FDA notes that symptoms of hepatitis can include: fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.

Reviewing the medical records and histories of patients identified by the Hawaiʻi DOH is part of the investigation; as is analyzing the composition of product samples that have been collected from some of the patients, says the FDA.

The FDA says it is also inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records.

The FDA health advisory further states that, “Because USPlabs LLC has informed FDA that it believes counterfeit versions of OxyElite Pro are being marketed in the US and have been on the US market for some time, the FDA is also investigating whether a counterfeit product is related to any of the cases of acute  hepatitis.”

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