The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) created the Drug-Induced Liver Injury (DILI) Network to collect and analyze cases of severe liver injury caused by prescription drugs, herbal products and supplements.

Two researchers involved in the network will discuss ongoing efforts to curb drug-induced liver injury (DILI) during an AASLD State-of-the-Art Lecture Monday morning titled DILI: Is this Pill Safe to Swallow?

Paul B. Watkins, MD, FAASLD, director of the University of North Carolina Institute for Drug Safety Sciences and professor of medicine, pharmacy and public health at the University of North Carolina at Chapel Hill, will present the lecture. Robert J. Fontana, MD, FAASLD, professor of internal medicine and medical director of liver transplantation at the University of Michigan, Ann Arbor, will moderate.

Robert J. Fontana, MD, FAASLD

Paul B. Watkins, MD, FAASLD

The network’s goals include describing the epidemiology of DILI and developing diagnostic serum tests to help physicians predict and manage DILI, Dr. Fontana said. DILI Network plans to publish criteria for making a DILI diagnosis, provide information about the likelihood that a drug can cause injury and develop severity scales to help physicians who care for patients with DILI.

“In DILI Network, we are seeing more and more cases of herbal and dietary supplement toxicity over time,” Dr. Fontana said. “There are currently substantial problems with the way over-the-counter herbal supplements are regulated — or rather, not regulated — in the U.S. and abroad.”

Dr. Watkins will discuss the LiverTox database, a joint effort of the NIDDK and the Division of Specialized Information Services within the National Library of Medicine at the National Institutes of Health.

“There is something like 200,000 people a month that use LiverTox,” Dr. Fontana said. “If you are seeing a patient with suspected drug-induced liver injury, you can go to the website and find a lot of useful information right at your fingertips.”

Dr. Watkins will also provide an update on the DILI-sim Initiative, a six-year-old public-private partnership involving scientists from major pharmaceutical companies, academia and the U.S. Food and Drug Administration that’s focused on developing computer-based models to understand and predict liver safety liabilities in new drug candidates.

Dr. Watkins will also discuss efforts to develop serum tests and biomarkers to determine whether a drug could be causing liver injury.
“Right now, it’s a diagnosis of exclusion. We would like to have a blood test that could tell us whether it’s more likely that the patient had a liver injury from drug X, Y or Z,” said Dr. Fontana, who noted that researchers are also looking at genetic susceptibility to DILI.

“We don’t yet know if the genetics are going to yield a better biomarker,” he said. “We don’t know if we are going to have a better blood test. But if you can’t reliably recognize and diagnose patients with DILI in clinical practice, we won’t be able to move the field forward.”

Please refer to the DDW Mobile App or the Program section in Monday’s DDW Daily News for additional details on this and other DDW® events.