The impact of drug-related QT prolongation on FDA regulatory decisions

International Journal of Cardiology

Volumn 168, Issue 5, 2013, Pages 4975-4976

  Park, Eunjung ^a   Willard, James ^a   Bi, Daoqin ^a   Fiszman, Monica ^a   Kozeli, Devi ^a   Koerner, John ^a  

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

Author keywords

Drug approval; QT prolongation; Safety warning

Indexed keywords

NILOTINIB; TOREMIFENE; VANDETANIB;

BREAST METASTASIS; CHRONIC MYELOID LEUKEMIA; CLINICAL PHARMACOLOGY; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG INDICATION; DRUG INTERACTION; DRUG LABELING; DRUG OVERDOSE; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; PRIORITY JOURNAL; PSYCHIATRY; QT INTERVAL; QT PROLONGATION; THYROID CANCER; TORSADE DES POINTES; ADVERSE DRUG REACTION; CHEMICALLY INDUCED; LONG QT SYNDROME; UNITED STATES;

DRUG APPROVAL; DRUG INTERACTIONS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; LONG QT SYNDROME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84886378706     PISSN: 01675273     EISSN: 18741754     Source Type: Journal    
DOI: 10.1016/j.ijcard.2013.07.136     Document Type: Article

References (4)

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3. Drug@FDA http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm [accessed 2013 May 24]
4. N. Stockbridge, J. Zhang, C. Garnett, and M. Malik Practice and challenges of thorough QT studies J Electrocardiol 45 2012 582 587