# 7846
There is an erroneous belief that whatever over-the-counter (OTC) medicines and supplements may lack in effectiveness, they make up for in safety. The truth is that most OTC meds, and even a lot of `natural’ supplements, are quite capable of causing illness or even death under the `right’ (read: `wrong’) dosage and/or circumstances.
Last week, in The Perils Of Not Knowing Your Dose, we looked at the impact of acetaminophen (Tylenol ®) overdoses in this country each year.
Last night the CDC issued a HAN Health Advisory, along with and advisory from the FDA, on an OTC weight loss product called OxyElite Pro that has been tentatively linked to a number of cases of acute hepatitis and/or liver failure.
The FDA recommendation is to:
`. . . stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner’
Here are some excerpts from the CDC’s HAN Alert.
Distributed via the CDC Health Alert Network
October 8, 2013, 2:30 ET (14:30 PM ET)
HANINFO-00356Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building
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; and
- 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.
<SNIP>
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 the local or state health department, as well as the US Food and Drug Administration’s MedWatch program online at https://www.accessdata.fda.gov/scripts/medwatch/ or by phone at 1-888-INFO-FDA.
- People who use dietary supplements for weight loss or muscle gain should do so with caution and under a medical provider’s close supervision.
And here is the Health Advisory from the FDA.
OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use
[Posted 10/08/2013]
AUDIENCE: Health Professional, Consumer
ISSUE: The FDA, along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH), are investigating a growing number of reports of acute non-viral hepatitis in Hawaii. The Hawaii DOH has reported that 24 of these cases share a common link to a dietary supplement product labeled as OxyElite Pro.
BACKGROUND: OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nation-wide through a wide range of distribution channels, including the internet and retail stores that sell dietary supplements. There have been 29 cases of acute non-viral hepatitis with an unknown cause identified in the state of Hawaii. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. CDC is also looking at other cases of liver injury nationwide that may be related. Symptoms of all types of hepatitis are similar and 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.
The epidemiological investigation is being conducted by the Hawaii DOH and the CDC. As part of FDA’s associated investigation, the agency is reviewing the medical records and histories of patients identified by the Hawaii DOH. The FDA is also analyzing the composition of product samples that have been collected from some of these patients. Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records. 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, FDA is also investigating whether counterfeit product is related to any of the cases of acute hepatitis.
RECOMMENDATION: The FDA advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues. Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/08/2013 - Recalls, Outbreaks & Emergencies - FDA]
[10/08/2013 - Health Alert Network Advisory - CDC]
