October 9, 2013
Surge Of Hawaiian Hepatitis Cases Point To Diet Pill As Culprit
Brett Smith for redOrbit.com - Your Universe Online
Health officials are acting quickly to inform consumers and begin an investigation of a growing number of non-viral hepatitis cases in Hawaii. Officials have linked the cases to a dietary supplement product labeled as OxyElite Pro, which is marketed as a weight-loss supplement.
"In the interest of protecting public health, we are moving quickly to learn as much as possible," the Food and Drug Administration said in a statement. "We recognize that people will be concerned about these illnesses, and we will provide updates as the investigation develops."
According to the FDA, there have been 29 reports of non-viral hepatitis, with 24 connected to OxyElite, which is made by USPLabs LLC of Dallas.
Non-viral hepatitis is a liver-damaging condition that cannot be passed from person to person but can be caused by alcoholism or drug use, including the excessive use of over-the-counter products such as Tylenol. Two patients have already undergone liver transplants to combat their condition.
USPLabs released a statement that said the company "stands by the safety of all of its products," and that "the cluster of liver issues in Hawaii is a complete mystery."
The company added that "out of an abundance of caution" it will stop distributing OxyElite Pro until the federal investigation is complete. USPLabs has said that it stopped making the original version of the supplement earlier this year after the FDA cracked down on supplements containing DMAA, a stimulant said to cause heart attacks.
In July, as a result of action taken by the FDA, USPLabs destroyed its DMAA-containing products, including OxyElite Pro with DMAA and Jack3d – believed to have cost the company over $8 million at the retail level.
The Centers for Disease Control and Prevention (CDC) has also been involved in the investigation and have said that the recent government shutdown began after they started looking into the hepatitis cases. Many FDA inspectors have been furloughed as a result of the shutdown, but reports have indicated that some have been called back to work on this particular case.
While the CDC and Hawaii Department of Health are looking into the source of the hepatitis outbreak, the FDA is said to be looking into the medical histories of patients identified by the Hawaii health department.
According to Pieter Cohen, an expert on dietary supplements with the Cambridge Health Alliance in Massachusetts, all the patients linked to the investigation tested negative for the viral forms of hepatitis. He told USA Today that "physicians must look carefully at medications and herbal ingredients that might be linked to the liver failure."
Cohen suggested that the supplements made by the USPLabs could have been mislabeled. "Unfortunately, we see that not infrequently with supplements. There's one thing on the label and something else in the pills," Cohen said."
The health expert added that consumers should be aware that there is no such thing as a fat-burning pill.
"The idea that there is a natural weight-loss pill out there is hogwash,” he told USA Today. “Either the pills don't work or they do work because they contain substances which are not natural and are pharmaceuticals.”