OTC Supplements Linked to Possible Fulminant Hepatic Failure

liver411

Medscape Medical News

Neil Osterweil

Nov. 2, 2002 (Boston) - In a study of candidates for liver transplantation
due to fulminant hepatic failure (FHF), researchers from Oregon Health
Science University (OHSU) in Portland found that the only possible
explanation for organ failure in 11 of the 20 patients was that they had
used either a weight loss supplement with or without the herb kava, or
common herbal supplements that are known or believed to be toxic to the
liver. They reported their findings here on Saturday at a poster session of
the 53rd Annual Meeting of the American Association for the Study of Liver
Diseases.

"This is an observation that we made at our institution when we noted that so many patients with fulminant failure seemed to have no explanation other than herbs or supplements, " said lead author David Stolpman, MD, a third-year fellow in gastroenterology at OHSU, in an interview with Medscape.

They retrospectively reviewed data on patients with FHF over a 22-month
period starting in January 2001. During that time, 20 patients presented
with FHF, identified by the development of jaundice followed by
encephalopathy without pre-existing chronic liver disease. The patients had all provided full, detailed medical histories that included history of
medication and supplement use, and other possible explanations were
explored, such as viral hepatitis, autoimmune disease, or metabolic
disorders.

They found that in 11 of the 20 patients, the use of over-the-counter weight loss supplements, a body-building supplement, or herbs used for energy or relaxation were the only possible explanations for the FHF. The supplements contained either unlabeled ingredients, or herbs that have previously been linked to liver damage, including kava, chaparral, dandelion root, skullcap, and ephedra, also known as ma huang.
In March 2002, the U.S. Food and Drug Administration (FDA) issued a consumer advisory warning that kava-containing supplements may be associated with severe liver injury. According to that advisory "kava-containing products have been associated with liver-related injuries - including hepatitis, cirrhosis, and liver failure - in over 25 reports of adverse events in other countries. Four patients required liver transplants. In the U.S., FDA has received a report of a previously healthy young female who required liver transplantation, as well as several reports of liver-related injuries." "I think that a lot of problems with these agents are that many are imported from foreign countries, where they don't have the same regulations for drug development, so there may be adulteration, or maybe these agents by themselves are directly related to causing toxicity as well," Abdul Nadir, MD, medical director of the Liver Disease Center at Good Samaritan Medical Center in Phoenix, Arizona, told Medscape.
Dr. Nadir notes that he has written several case reports of FHF associated
with the use of ephedra, and at least one with the use of cascada sagrada
bark, which is widely used as a natural laxative. He says that the liver
damage from exposure to a "natural" toxin can occur within a few weeks or up to six months after exposure.

Dr. Stolpman told Medscape that although there is intriguing evidence
pointing to supplement use and FHF, there is still no smoking gun. "We've
just made the observation that supplements and herbs seem to be associated with fulminant hepatic failure. We're not necessarily making a causative argument here, but clearly there is some association."
AASLD 53rd Annual Meeting: Abstract 8. Presented Nov. 2, 2002.
Reviewed by Gary D. Vogin, MD