What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling

Pharmacoepidemiology and Drug Safety

Volumn 13, Issue 4, 2004, Pages 201-206

  Willy, Mary E ^a   Li, Zili ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

FDA; Hepatic failure; Labeling

Indexed keywords

ALLOPURINOL; ALOPRIM; AMIODARONE; AMPHOTERICIN B LIPID COMPLEX; CAPTOPRIL; CELECOXIB; CERIVASTATIN; CIPROFLOXACIN; CITALOPRAM; CLARITHROMYCIN; COTRIMOXAZOLE; DACARBAZINE; DOXORUBICIN; FLUCONAZOLE; GANCICLOVIR; INDINAVIR; LIVER ENZYME; LORATADINE; OLSALAZINE; PEMOLINE MAGNESIUM; PERINDOPRIL; PIOGLITAZONE; PROBENECID; QUINAPRIL; RAMIPRIL; ROSIGLITAZONE; SULINDAC; TACRINE; UNINDEXED DRUG; VALPROIC ACID; ZAFIRLUKAST;

ARTICLE; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG MARKETING; DRUG MONITORING; DRUG RESEARCH; DRUG SCREENING; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERPERSONAL COMMUNICATION; LIVER DISEASE; LIVER FAILURE; LIVER NECROSIS; MEDICAL LITERATURE; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; RISK ASSESSMENT; SCORING SYSTEM; TIME; UNITED STATES;

COMMUNICATION; DRUG LABELING; HUMANS; LIVER; PRESCRIPTIONS, DRUG; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 1942488289     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.856     Document Type: Article

References (2)

1. US Code of Federal Regulations, Part 21; 201.57. US Government Printing Office, Washington, 2001.
2. Managing the risks from medical product use: creating a risk management framework. Report to the FDA Commissione from the Task Force on Risk Management, HHS, FDA, May, 1999. www.fda.gov/oc/tfrm/riskmanagement.pdf [7 January 2003].