Postmarket safety events among novel therapeutics approved by the US food and drug administration between 2001 and 2010

JAMA - Journal of the American Medical Association

Volumn 317, Issue 18, 2017, Pages 1854-1863

  Downing, Nicholas S ^a   Shah, Nilay D ^b   Aminawung, Jenerius A ^c   Pease, Alison M ^d   Zeitoun, Jean David ^e,f   Krumholz, Harlan M ^c,g,h,i   Ross, Joseph S ^c,g,h,i  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b MAYO CLINIC   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d SUNY DOWNSTATE MEDICAL CENTER   (United States)

^e HÔPITAL SAINT ANTOINE   (France)

^f GROUPE HOSPITALIER DIACONESSES CROIX SAINT SIMON   (France)

^g ROBERT WOOD JOHNSON FOUNDATION   (United States)

^h YALE UNIVERSITY   (United States)

ⁱ YALE NEW HAVEN HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; EFALIZUMAB; MONOCLONAL ANTIBODY; NEUROLEPTIC AGENT; ORPHAN DRUG; PHOSPHODIESTERASE V INHIBITOR; SEROTONIN UPTAKE INHIBITOR; TEGASEROD; TRIPTAN DERIVATIVE; VALDECOXIB; BIOLOGICAL PRODUCT;

CARDIOVASCULAR DISEASE; DRUG APPROVAL; DRUG RECALL; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; IRRITABLE COLON; MENTAL DISEASE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PSORIASIS; REVIEW; UNITED STATES; UNSPECIFIED SIDE EFFECT; ADVERSE DRUG REACTION; COHORT ANALYSIS; RISK; SAFETY;

BIOLOGICAL PRODUCTS; COHORT STUDIES; DRUG APPROVAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK; SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85019462990     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.5150     Document Type: Review

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