HomeMy WebLinkAbout20131021_Acute Hepatitis and Liver Failure Dietary Supplement (PDF) (1)JEFFERSON COUNTY PUBLIC HEALTH
615 Sheridan Street Port Townsend Washington 98368
www.jeffersoncountypublichealth.org
COMMUNITY HEALTH
DEVELOPMENTAL DISABILITIES
MAIN: 360-385-9400
FAX: 360-385-9401
ENVIRONMENTAL HEALTH
NATURAL RESOURCES
MAIN: 360-385-9444
FAX: 360-385-9401
CDC Health Advisory
Acute Hepatitis and Liver Failure Following the Use of a Dietary
Supplement Intended for Weight Loss or Muscle Building
October 21, 2013
Dear Colleagues:
I received this advisory from the CDC and wanted to pass it along to keep you informed and on the
lookout for severe cases of hepatitis. If you have any suspect patients, please contact us at 360-385-
9400.
Summary: Recently, a number of previously healthy individuals developed acute hepatitis and sudden
liver failure of unknown cause after using a dietary supplement for weight loss or muscle building. CDC
recommends increased vigilance by public health agencies, emergency departments, and healthcare
providers for patients who develop acute hepatitis or liver failure following use of a weight loss or muscle
building nutritional supplement. CDC requests that state health departments report such occurrences to
the CDC. CDC also recommends that, as part of a comprehensive evaluation, clinicians evaluating patients
with acute hepatitis should ask about consumption of dietary supplements.
Background:
On September 9, 2013, the Hawaii Department of Health (DOH) was notified of seven patients with
severe acute hepatitis and sudden liver failure of unknown cause. The patients were previously
healthy and sought medical care from May through September 2013. Clinicians reported that the
seven patients had all used OxyELITE Pro, a dietary supplement marketed for weight loss and muscle
gain, prior to illness onset.
The investigation is ongoing and the data presented are preliminary. Thus far, clinicians have reported
45 patients to the Hawaii DOH in response to a public health alert. Of those, 29 patients, including the
original seven, were confirmed to have acute hepatitis after using a nutritional supplement for weight
loss or muscle building. The median age of the 29 patients is 33 years; 14 (48%) are male. The date of
the first reported laboratory test was used as a proxy for illness onset and ranged from May 10
through October 3, 2013. The most commonly reported symptoms included loss of appetite, light-
colored stools, dark urine, and jaundice. Median laboratory values reported at the peak of illness were
the following:
aspartate aminotransferase (AST) 1,128 IU/L
alanine transaminase (ALT) 1,793 IU/L
alkaline phosphatase 150 IU/L
total bilirubin 12.6 mg/dL
Ten patients had liver biopsy data available at the time of this report. Seven had histology consistent
with hepatitis from drug/toxic injury, with findings including hepatocellular necrosis and cholestasis.
Three patients had liver biopsy findings of acute hepatitis associated with other etiologies such as
autoimmune hepatitis. Eleven (38%) patients were hospitalized, with a median duration of seven days.
One patient died, and two patients received liver transplants. Two remain hospitalized, and all other
hospitalized patients have been discharged.
Of the 29 identified patients, 24 (83%) reported using OxyELITE Pro during the 60 days prior to illness
onset. There was no other dietary supplement or medication use reported in common by more than
two patients.
National case finding efforts have identified several individuals from states outside Hawaii with
reported OxyELITE Pro or other weight loss or muscle building dietary supplement use prior to the
development of acute hepatitis of unknown cause. CDC, in collaboration with state health departments,
is collecting additional clinical and epidemiologic information from these individuals to determine if
this outbreak is national in scope.
Case definition:
An individual with acute-onset hepatitis of unknown etiology that developed symptoms on or after
April 1, 2013 following use of a non-prescription weight loss or muscle building dietary supplement
during the 60 days prior to illness onset.
With acute-onset hepatitis of unknown etiology defined as having BOTH:
- ALT > 4 times the upper limit of normal
- Total bilirubin > 2 times the upper limit of normal
AND
-negative workup for infectious or other explicative etiologies for hepatitis.
Workup for other potential etiologies should include:
- Hepatic imaging (i.e., ultrasound/doppler, CT scan, MRI) not consistent
with alternative, explicative etiologies
- Negative viral hepatitis panel
- No pre-existing diagnosis of chronic liver disease (e.g., autoimmune
hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis,
Wilson’s disease, hemochromatosis)
- No recent hypotensive shock or septic episodes
- No history of alcoholism documented in medical records
Recommendations:
Clinicians evaluating patients with acute hepatitis should ask about consumption of dietary
supplements as part of a comprehensive evaluation.
Clinicians should report patients meeting the case definition to Jefferson County Public Health,
as well as the US Food and Drug Administration’s MedWatch program online at
www.accessdata.fda.gov/scripts/medwatch/ or by phone at 1-888-INFOFDA.
People who use dietary supplements for weight loss or muscle gain should do so with caution
and under a medical provider’s close supervision.
For more information:
Please call 360-385-9400 to report cases or if you have additional questions. This message will be
posted on our website, see Information for Providers, www.jeffersoncountypublichealth.org.
Sincerely,
Tom Locke, MD MPH
Jefferson County Health Officer
Jefferson County Public Health
360-385-9400 (office)