Emergency use authorization for intravenous peramivir: Evaluation of safety in the treatment of hospitalized patients infected with 2009 H1N1 influenza a virus

Clinical Infectious Diseases

Volumn 55, Issue 1, 2012, Pages 1-7

  Sorbello, Alfred ^a   Jones, S Christopher ^a   Carter, Wendy ^a   Struble, Kimberly ^a   Boucher, Robert ^b   Truffa, Melissa ^a   Birnkrant, Debra ^a   Gada, Neha ^a   Camilli, Sara ^a   Chan, Irene ^a   Dallas, Scott ^a   Scales, Twanda ^a   Kosko, Robert ^a   Thompson, Elizabeth ^a   Goodman, Jesse ^a   Francis, Henry ^a   Dal Pan, Gerald ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

OSELTAMIVIR; PERAMIVIR;

2009 H1N1 INFLUENZA; ACUTE KIDNEY FAILURE; ADOLESCENT; ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; AGITATION; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANGIONEUROTIC EDEMA; ARTIFICIAL VENTILATION; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BRAIN DEATH; CARDIOPULMONARY INSUFFICIENCY; CHILD; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CRITICALLY ILL PATIENT; DELIRIUM; DIARRHEA; DISEASE SEVERITY; DRUG FATALITY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HALLUCINATION; HEALTH CARE PERSONNEL; HEART ARREST; HEMATURIA; HOSPITAL PATIENT; HUMAN; HYPOTENSION; HYPOXIA; KIDNEY DISEASE; LIVER FUNCTION TEST; MULTIPLE ORGAN FAILURE; PANCREATITIS; PNEUMONIA; PNEUMOTHORAX; PRIORITY JOURNAL; RASH; RENAL REPLACEMENT THERAPY; REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; SINUS BRADYCARDIA; SINUS TACHYCARDIA; TINNITUS;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; CHILD; CHILD, PRESCHOOL; CYCLOPENTANES; DRUG TOXICITY; DRUG UTILIZATION; FEMALE; GUANIDINES; HOSPITALIZATION; HUMANS; INFANT; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; MALE; MIDDLE AGED; PREGNANCY; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84862169991     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cis351     Document Type: Review

References (16)

1. Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of a novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med 2009; 360:2605-15.
2. Centers for Disease Control and Prevention. Update: influenza activity-United States, 2009-2010 season. MMWR Morb Mortal Wkly Rep 2010; 59:901-8.
3. Siston AM, Rasmussen SA, Honein MA, et al.; for the Pandemic H1N1 Influenza in Pregnancy Working Group. Pandemic 2009 influenza A (H1N1) illness among pregnant women in the United States. JAMA 2010; 303:1517-25.
4. Babu YS, Chand P, Bantia S, et al. BCX-1812 (RWJ-270201): discovery of a novel, highly potent, orally active, and selective influenza neuraminidase inhibitor through structure-based drug design. J Med Chem 2000; 43:3482-6.
5. Birnkrant D, Cox E. The emergency use authorization of peramivir for treatment of 2009 H1N1 influenza. N Engl J Med 2010; 361:2204-7.
6. US Food and Drug Administration. Emergency Use Authorization of peramivir IV fact sheet for health care providers. Available at: http://www.fda.gov/ downloads/drugs/drugsafety/postmarketdrugsafetyinformat ionforpatientsandproviders/ucm187811.pdf. Accessed 4 April 2012.
7. MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (lFPMA).
8. Yu Y, Garg S, Yu P, et al. Peramivir Use for the Treatment of Hospitalized Patients with Influenza A (H1N1) pdm09 under Emergency Use Authorization, October 2009-June 2010. Clin Infect Dis 2012; in press.
9. ANZIC Influenza Investigators. Critical care services and 2009 H1N1 influenza in Australia and New Zealand. N Engl J Med 2009; 361: 1925-34.
10. Dominguez-Cherit G, Lapinsky SE, Macias AE, et al. Critically ill patients with 2009 influenza A (H1N1) in Mexico. JAMA 2009; 302:1880-7.
11. Estensoro E, Rios FG, Apezteguia C, et al.; for the Registry of the Argentinian Society of Intensive Care (SATI). Pandemic 2009 influenza A in Argentina. Am J Respir Crit Care Med 2010; 182:41-8.
12. Kumar A, Zarychanski R, Pinto R, et al.; for the Canadian Critical Care Trials Group H1N1 Collaborative. Critically ill patients with 2009 influenza A (H1N1) infection in Canada. JAMA 2009; 302:1872-9.
13. Writing Committee of the WHO Consultation on Clinical Aspects of Pandemic (H1N1) 2009 Influenza. Clinical aspects of pandemic 2009 influenza A (H1N1) virus infection. N Engl J Med 2010; 362:1708-19.
14. Lee EH, Wu C, Lee EU, et al.; for the New York City Department of Health and Mental Hygiene 2009 H1N1 Influenza Investigation Team. Fatalities associated with the 2009 H1N1 influenza A virus in New York City. Clin Infect Dis 2010; 50:1498-504.
15. Kohno S, Kida H, Mizuguchi M, Shimada J; for the S-021812 Clinical Study Group. Efficacy and safety of intravenous peramivir for treatment of seasonal influenza virus infection. Antimicrob Agents Chemother 2010; 54:4568-74.
16. Kohno S, Kida H, Mizuguchi M, et al.; for the S-021812 Clinical Study Group. Antimicrob Agents Chemother 2011; 55:2803-12.