Open AccessEmergency Use Authorization for Intravenous Peramivir: Evaluation of Safety in the Treatment of Hospitalized Patients Infected With 2009 H1N1 Influenza A Virus
Author(s) -
Alfred Sorbello,
S. Christopher Jones,
W. Carter,
Kimberly Struble,
R. C. Boucher,
Melissa M. Truffa,
Debra Birnkrant,
Neha Gada,
S. Camilli,
Iris T. Chan,
Steven D. Dallas,
Thomas Scales,
R. Kosko,
E. Thompson,
Julie E. Goodman,
Henry Francis,
Gerald J. Dal Pan
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/cis351
Subject(s) - medicine , rash , adverse effect , neuraminidase inhibitor , oseltamivir , adverse event reporting system , intensive care medicine , concomitant , emergency medicine , covid-19 , disease , infectious disease (medical specialty)
On 23 October 2009, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for intravenous peramivir, an unapproved antiviral, to treat suspected or confirmed 2009 H1N1 influenza A virus infection. Eligible hospitalized patients were unresponsive to or unable to tolerate available antivirals or lacked dependable oral or inhaled drug delivery routes. The EUA required healthcare providers to report medication errors, selected adverse events (AEs), serious AEs, and deaths to the FDA.
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