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Antibiotics Single largest class of drugs
causing liver injury…Study finds CNS agents
also commonly associated with drug-induced
liver injury
Bethesda, MD (Dec. 1, 2008) – Antibiotics
are the single largest class of agents that
cause idiosyncratic drug-induced liver
injury (DILI), reports a new study in
Gastroenterology, an official journal of the
American Gastroenterological Association (AGA)
Institute.
DILI is the most common cause of death from
acute liver failure and accounts for
approximately 13 percent of cases of acute
liver failure in the U.S. It is caused by a
wide variety of prescription and
nonprescription medications, nutritional
supplements and herbals.
"DILI is a serious health problem that
impacts patients, physicians, government
regulators and the pharmaceutical industry,"
said Naga P. Chalasani, MD, of the Indiana
University School of Medicine and lead
author of the study.
"Further efforts are needed in defining its
pathogenesis and developing means for the
early detection, accurate diagnosis,
prevention and treatment of DILI."
In this prospective, ongoing, multi-center
observational study — the largest of its
kind — patients with suspected DILI were
enrolled based upon predefined criteria and
followed for at least six months. Those with
acetaminophen liver injury were excluded.
Researchers found that DILI was caused by a
single prescription medication in 73 percent
of the cases, by dietary supplements in 9
percent and by multiple agents in 18
percent.
More than 100 different agents were
associated with DILI; antimicrobials (45.5
percent) and central nervous system agents
(15 percent) were the most common.
Of the dietary supplements causing DILI,
compounds that claim to promote weight loss
and muscle building accounted for nearly 60
percent of the cases.
The study found that at least 20 percent of
patients with DILI ingest more than one
potentially hepatotoxic agent.
DILI remains a diagnosis of exclusion and
thus detailed testing should be performed to
exclude competing causes of liver disease;
importantly, acute hepatitis C virus (HCV)
infection should be carefully excluded in
patients with suspected DILI by HCV RNA
testing. Researchers found no relationship
between gender and severity of DILI, but
individuals with diabetes experienced more
severe DILI.
###
This study is an initial analysis of an
ongoing prospective study of DILI. Its
primary aim is to develop well-characterized
cases of medication-related liver injury on
which to conduct hypothesis-driven research
targeted at developing means to diagnose,
prevent and treat DILI.
DILI is the most frequent adverse
drug-related event leading to abandonment of
potentially promising new drug candidates
during pre-clinical or clinical development,
failure to achieve drug approval, and
withdrawal or restriction of prescription
drug use after approval.
The Drug-Induced Liver Injury Network is
funded by the National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK)
and was established in 2003 and will operate
through 2013.
It consists of eight clinical centers, one
data coordinating center and NIDDK
investigators. Visit
http://dilin.dcri.duke.edu/ to
learn more.
About the AGA
Institute
The American Gastroenterological Association
(AGA) is dedicated to the mission of
advancing the science and practice of
gastroenterology.
Founded
in 1897, the AGA is one of the oldest
medical-specialty societies in the U.S.
Comprised of two non-profit
organizations—the AGA and the AGA
Institute—our more than 16,000 members
include physicians and scientists who
research, diagnose and treat disorders of
the gastrointestinal tract and liver.
The AGA, a 501(c6) organization, administers
all membership and public policy activities,
while the AGA Institute, a 501(c3)
organization, runs the organization's
practice, research and educational programs.
On a monthly basis, the AGA Institute
publishes two highly respected journals,
Gastroenterology and Clinical
Gastroenterology and Hepatology.
The
organization's annual meeting is Digestive
Disease Week®, which is held each May and is
the largest international gathering of
physicians, researchers and academics in the
fields of gastroenterology, hepatology,
endoscopy and gastrointestinal surgery. For
more information, please visit
www.gastro.org.
About Gastroenterology
Gastroenterology, the official journal of
the AGA Institute, is the most prominent
scientific journal in the specialty and is
in the top 1 percent of indexed medical
journals internationally.
The journal publishes clinical and basic
science studies of all aspects of the
digestive system, including the liver and
pancreas, as well as nutrition.
The journal is abstracted and indexed in
Biological Abstracts, CABS, Chemical
Abstracts, Current Contents, Excerpta Medica,
Index Medicus, Nutrition Abstracts and
Science Citation Index. For more
information, visit
www.gastrojournal.org.
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