How the FDA manages drug safety with black box warnings, use restrictions, and drug removal, with attention to gastrointestinal medications

American Journal of Gastroenterology

Volumn 107, Issue 4, 2012, Pages 501-504

  Ehrenpreis, Eli D ^a   Ciociola, Arthur A ^b   Kulkarni, Prasad M ^c   Kefalas, Costas ^d   Buchman, Alan ^d   Burke, Carol ^d   Cain, Tedd ^d   Connor, Jason ^d   Fang, John ^d   Fass, Ronnie ^d   Phillips, Joseph ^d   Pochapin, Mark ^d   Pockros, Paul ^d   Schoenfeld, Philip ^d   Vuppalanchi, Raj ^d  

^a NORTHSHORE UNIVERSITY HEALTHSYSTEM   (United States)

^b Bausch+Lomb   (United States)

^c UNIVERSITY OF SOUTH FLORIDA   (United States)

^d NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADALIMUMAB; ALOSETRON; CERTOLIZUMAB PEGOL; CISAPRIDE; DOMPERIDONE; GASTROINTESTINAL AGENT; INFLIXIMAB; METOCLOPRAMIDE; NATALIZUMAB; PLACEBO; TEGASEROD;

ABDOMINAL DISCOMFORT; BLOATING; CONSTIPATION; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL DISEASE; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HOSPITALIZATION; HUMAN; IMMUNOMODULATION; IRRITABLE COLON; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; SHORT SURVEY; TORSADE DES POINTES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG LABELING; DRUG TOXICITY; GASTROINTESTINAL AGENTS; GASTROINTESTINAL DISEASES; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK MANAGEMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84859589065     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2011.449     Document Type: Short Survey

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