# The Drug Induced Liver Injury Network (DILIN): Focus on Herbal and DietarySupplements

> **NIH NIH U01** · ALBERT EINSTEIN HEALTHCARE NETWORK · 2021 · $400,000

## Abstract

PROJECT SUMMARY
The Einstein Medical Center will continue to recruit cases for the three DILIN protocols; prospective,
retrospective, and acute, and to participate in all of its procedures and ancillary studies. At Einstein, we will
focus our investigative approach on liver injury from Herbal and Dietary Supplements (HDS). Specifically, our
approach will entail expansion of prospective enrollment of DILI cases due to HDS, especially those with early
injury, using an innovative marketing method termed Search Engine Optimization, whereby the internet will be
exploited as a recruitment tool. We will support ongoing chemical analysis of HDS collected from DILIN
enrollees in collaboration with the National Center for Natural Products Research (NCNPR) at the University of
Mississippi. In order to more fully characterize liver injury associated with HDS, we will oversee several
activities. First, we will participate with Dr. David Kleiner from the NIH in a detailed review of the
histopathology associated with liver injury from HDS by informing his review with chemical analysis and
detailed clinical information. Second, we will oversee a case-by-case review of previously adjudicated cases,
taking into consideration newly available chemical analyses of HDS, proposing adjustment to final causality
determinations as appropriate. Third, we will, conduct a nested case/control study to identify those factors
associated with use of HDS that affect the odds of developing liver injury. This grant will also explore the
toxicity of HDS, focusing on Green Tea Extract, a commonly used ingredient of HDS for which there is
significant evidence for toxicity; our findings will provide guidance to scientists, regulators, and consumers on
the safe use of this ingredient, and define an approach to further research with other natural product
ingredients. Finally, we will reduce the turn-around time for product analysis, thus refining the DILIN causality
assessment process by incorporating chemical analysis results into its adjudication process. This quicker turn-
around time will also facilitate pharmacovigilance efforts in collaboration with the Food and Drug
Administration. We will also collaborate with the CDC to support an eventual early warning system for
outbreaks of liver injury due to HDS by providing product and de-identified case information on confirmed
cases of liver injury due to HDS; this information will allow the detection of outbreaks of attributable liver injury.
To support all of our aims, we will continue to oversee and DILIN HDS repository as a critical resource of the
DILIN.

## Key facts

- **NIH application ID:** 10234155
- **Project number:** 5U01DK083027-15
- **Recipient organization:** ALBERT EINSTEIN HEALTHCARE NETWORK
- **Principal Investigator:** VICTOR J NAVARRO
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $400,000
- **Award type:** 5
- **Project period:** 2008-09-30 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10234155

## Citation

> US National Institutes of Health, RePORTER application 10234155, The Drug Induced Liver Injury Network (DILIN): Focus on Herbal and DietarySupplements (5U01DK083027-15). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10234155. Licensed CC0.

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