Editorial commentary: What did we learn from the emergency use authorization of peramivir in 2009?

Clinical Infectious Diseases

Volumn 55, Issue 1, 2012, Pages 16-18

  Pavia, Andrew T ^a  

^a UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMANTADINE; OSELTAMIVIR; PERAMIVIR; RIMANTADINE; VIRUS SIALIDASE; ZANAMIVIR;

2009 H1N1 INFLUENZA; ANTIVIRAL RESISTANCE; ARTIFICIAL VENTILATION; CRITICALLY ILL PATIENT; DRUG EFFICACY; DRUG FATALITY; DRUG USE; EMERGENCY MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH SURVEY; HUMAN; INFLUENZA VIRUS A H1N1; INTENSIVE CARE UNIT; KIDNEY DISEASE; MEDICATION ERROR; MORTALITY; NOTE; PRIORITY JOURNAL; RENAL REPLACEMENT THERAPY; UNITED STATES;

ANTIVIRAL AGENTS; CYCLOPENTANES; EMERGENCY TREATMENT; FEMALE; GUANIDINES; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; MALE; PREGNANCY;

EID: 84862164072     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cis365     Document Type: Note

References (16)

1. Jain S, Kamimoto L, Bramley AM, et al. Hospitalized patients with 2009 H1N1 influenza in the United States, April-June 2009. N Engl J Med 2009; 361:1935-44.
2. Louie JK, Acosta M, Winter K, et al. Factors associated with death or hospitalization due to pandemic 2009 influenza A(H1N1) infection in California. JAMA 2009; 302: 1896-902.
3. Dharan NJ, Gubareva LV, Meyer JJ, et al. Infections with oseltamivir-resistant influenza A(H1N1) virus in the United States. JAMA 2009; 301:1034-41.
4. Moscona A. Global transmission of oseltamivir-resistant influenza. N Engl J Med 2009; 360:953-6.
5. World Health Organization. Oseltamivirresistant pandemic (H1N1) 2009 influenza virus, October 2009. Wkly Epidemiol Rec 2009; 84:453-9.
6. Mai LQ, Wertheim HF, Tran ND, van Doorn HR, Nguyen TH, Horby P. A community cluster of oseltamivir-resistant cases of 2009 H1N1 influenza. N Engl J Med 2010; 362:86-7.
7. Hernandez JE, Adiga R, Armstrong R, et al. Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an emergency IND program in the United States. Clin Infect Dis 2011; 52:695-706.
8. Birnkrant D, Cox E. The Emergency Use Authorization of peramivir for treatment of 2009 H1N1 influenza. N Engl J Med 2009; 361:2204-7.
9. Sorbello A, Jones S, Carter WW, et al. Emergency Use Authorization for intravenous peramivir: evaluation of safety in the treatment of hospitalized patients infected with 2009 H1N1 Influenza A virus. Clin Infect Dis 2012; 54:1-7.
10. Yu Y, Garg S, Yu P, et al. Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm092 under Emergency Use Authorization, October 2009-June 2010. Clin Infect Dis 2012; 54:8-15.
11. Kohno S, Kida H, Mizuguchi M, et al. Intravenous peramivir for treatment of influenza A and B virus infection in high-risk patients. Antimicrob Agents Chemother 2011; 156:512-24
12. Infectious Diseases Society of America. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts. Clin Infect Dis 2009; 49:328-35.
13. Hsu J, Santesso N, Mustafa R, et al. Antivirals for treatment of influenza: a systematic review and meta-analysis of observational studies. Ann Intern Med 2012; 156:512-24.
14. Bompey N. FDA seeks authority in PAHPA to gather data on countermeasures post EUA. Inside Health Policy. Available at: http://www.InsideHealthPolicy.com. Accessed 6 March 2012.
15. Woodcock J. Evidence vs. access: can twentyfirst-century drug regulation refine the tradeoffs? Clin Pharmacol Ther 2012; 91:371-80.
16. News Release: IDSA Proposes New Pathway for Antibiotic Approval 8 March 2012. http://www.idsociety.org/New-Pathway-for-Antibiotic-Approval/. Accessed 4 April 2012.