Evolution of the Food and Drug Administration Approach to Liver Safety Assessment for New Drugs: Current Status and Challenges

• Published in: Drug safety Vol. 37; no. Suppl 1; pp. 9 - 17
• Main Author: Senior, John R.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.11.2014; Adis International; Springer Nature B.V
• Subjects: Animals; Biological and medical sciences; Biomarkers; Chemical and Drug Induced Liver Injury - diagnosis; Chemical and Drug Induced Liver Injury - etiology; Chemical and Drug Induced Liver Injury - prevention & control; Clinical trials; Colleges & universities; Diagnosis, Computer-Assisted; Drug Design; Drug Safety and Pharmacovigilance; Drug toxicity and drugs side effects treatment; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drugs; FDA approval; Food; Humans; Liver; Medical sciences; Medicine; Medicine & Public Health; Mortality; Pharmaceutical industry; Pharmacology. Drug treatments; Pharmacology/Toxicology; Product safety; Public private partnerships; Review; Review Article; Risk assessment; Safety-Based Drug Withdrawals - statistics & numerical data; Toxicity: digestive system; United States; United States Food and Drug Administration; United States > US; Adverse Event Reporting System; Bromfenac; Telithromycin; Hepatocellular Injury; Troglitazone; Human; Drug; Evaluation; Liver function; Digestive system; Toxicity; Biological marker; Digestive diseases; Evolution; Hepatic disease; Pharmacovigilance; Food and Drug Administration

Prompted by approval in 1997 of troglitazone and bromfenac, two drugs that promptly began to show serious and sometimes fatal liver toxicity, we began at the Food and Drug Administration (FDA) a series of annual conferences in 1999 to consider issues of drug-induced liver injury (DILI). First inviti...