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Clinical and Research Information on Drug-Induced Liver Injury

A guide to reporting a case of drug-induced liver disease

For most medications, drug induced liver injury is uncommon, idiosyncratic and unpredictable. For these reasons, drug-induced liver injury usually is difficult to diagnose, a challenge to manage and treat, and almost impossible to prevent. Awareness or suspicion of drug-induced liver disease, however, is critically important because otherwise the diagnosis may be missed and harm done by continuing the drug or supplement in the face of worsening liver injury. Thus, the most important and critical part of management of drug induced liver injury is early diagnosis and prompt discontinuation of the suspected agent. Another important element of management, that is commonly overlooked, is to REPORT the case. The case first must be reported to the patient or patient’s family. Instructions should be given that the medication should be avoided in the future. It is prudent to ask the patient or family members to rid the home of the medication suspected to have caused liver injury. The residual medication can be given to the physician or a pharmacist to destroy. If the medication is unusual, such as an herbal, traditional medication, or nutritional supplement, it may be best to have it tested for purity and composition.

Reporting a Case to MedWatch

The case of drug-induced liver injury should also be reported to the Food and Drug Administration (FDA). Reports to the FDA are easy to prepare and represent responsible citizenship. The reporting is to "MedWatch" which can be done on line at MedWatch forms can also be filled out by hand and sent by Fax or mail to the FDA: forms are available at the website above or by telephone request: toll free at 1-800-332-1088. The website link above will take you directly to the FDA MedWatch site. Filling out the forms takes 10 to 15 minutes if you have the information at hand. To assist the LiverTox site visitor in collecting and organizing clinical information needed to report a case to MedWatch, an on-line form (Important Elements in Reporting of Drug-Induced Liver Injury) is available. This form can be printed out and used as a work sheet to facilitate the MedWatch submission. The form provides a check list of clinical elements that are important in establishing the diagnosis, excluding other causes of liver disease and defining the severity, course and outcome of the liver injury.

Reporting a case to LiverTox

Importantly, we welcome the site visitor to submit a clinical case of drug induced liver injury to LiverTox on-line. The web site provides prompts to enter the essential clinical information and provides a means of printing out the submitted data and a written summary of the case in text with a table or a graph. The summary is a concise description of the case that can be added to a patient chart or as a consultant note. The summary also includes calculation of helpful factors, such as the time to onset and recovery, the severity scale, RUCAM assessment of causality and a completeness score. Entering the information into the website takes 15-30 minutes depending upon the complexity of the case and whether you have the clinical information available. Entering the case requires that you provide your name and email and create a password. The clinical information will remain available to you and will be entered into a database maintained by LiverTox in an attempt to assess trends in drug induced liver injury. The on-line submission can be directed to MedWatch and the data will contribute to a more complete body of data on liver injury caused by drugs and dietary supplements.

Jay H. Hoofnagle, MD
Director, Liver Diseases Research Branch
Division of Digestive Diseases and Nutrition
Jose Serrano MD, PhD
Director, Liver and Biliary Programs
Division of Digestive Diseases and Nutrition