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U.S. FDA investigates outbreak of non-viral hepatitis in Hawaii

Source: Reuters - Tue, 8 Oct 2013 20:18 GMT
Author: Reuters
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(Updates with details of outbreak)

By Toni Clarke

WASHINGTON, Oct 8 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it is investigating a growing number of reports of non-viral hepatitis in Hawaii that have led to 11 hospitalizations and one death.

The FDA said the common link between at least some of the cases appears to be a dietary supplement called OxyElite Pro, which is distributed by USPlabs LLC of Dallas, Texas, and sold nationwide through the Internet and retail stores.

The FDA said there have been 29 reports of the liver-damaging condition, with 24 sharing the OxyElite connection. Two patients have received liver transplants.

The Centers for Disease Control and Prevention is looking at other cases of liver injury nationwide that may be related, the FDA said.

Steven Immergut, a spokesman for the FDA, said the agency has recalled "a couple" of technical experts who had been furloughed due to the government shutdown. The CDC said it had already begun responding to the situation at the time of the shutdown and has not had to change its staffing.

Several hundred FDA investigators have been furloughed, Immergut said. Those still working are prioritizing their activities based on public health needs "and are being deployed to situations like this that require immediate attention," he said.

The FDA said USPlabs will cease distributing OxyElite Pro as it cooperates with the investigation. The company believes counterfeit versions of OxyElite Pro are being marketed in the United States, the FDA said. The agency is investigating whether counterfeit product is related to any of the cases of acute hepatitis.

The CDC and Hawaii Department of Health are spearheading the investigation into the source of the outbreak. The FDA is reviewing medical records and histories of patients identified by the Hawaii health department. The agency said it is also analyzing the composition of product samples collected from some of the patients.

"In the interest of protecting public health, we are moving quickly to learn as much as possible," the FDA said in a statement. "We recognize that people will be concerned about these illnesses, and we will provide updates as the investigation develops." (Reporting by Toni Clarke in Washington; Editing by Steve Orlofsky and Chris Reese)

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