Open AccessExcess Deaths Associated With Tigecycline After Approval Based on Noninferiority Trials
Author(s) -
Paritosh Prasad,
Junfeng Sun,
Robert L. Danner,
Charles Natanson
Publication year - 2012
Publication title -
clinical infectious diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.44
H-Index - 336
eISSN - 1537-6591
pISSN - 1058-4838
DOI - 10.1093/cid/cis270
Subject(s) - tigecycline , medicine , food and drug administration , clinical trial , intensive care medicine , pharmacology , antibiotics , microbiology and biotechnology , biology
On the basis of noninferiority trials, tigecycline received Food and Drug Administration (FDA) approval in 2005. In 2010, the FDA warned in a safety communication that tigecycline was associated with an increased risk of death.
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