Original research: Intravenous ribavirin - Review of the FDA's emergency investigational new drug database (1997-2008) and literature review

Postgraduate Medicine

Volumn 121, Issue 3, 2009, Pages 5-15

  Riner, Andrea ^a   Chan Tack, Kirk M ^a   Murray, Jeffrey S ^a  

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

Author keywords

Adverse events; Emergency investigational new drug application; Intravenous; Ribavirin

Indexed keywords

RIBASPHERE; RIBAVIRIN; UNCLASSIFIED DRUG; ANTIVIRUS AGENT; NEW DRUG;

ADENOVIRUS; ADENOVIRUS INFECTION; ANEMIA; DATA BASE; DRUG APPROVAL; DRUG FORMULATION; DRUG INDICATION; DRUG UTILIZATION; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; GINGIVA SWELLING; HANTAVIRUS; HEMORRHAGIC FEVER; HUMAN; HYPOCALCEMIA; HYPOMAGNESEMIA; INFLUENZA; LA CROSSE VIRUS; LASSA FEVER; LIP SWELLING; LOADING DRUG DOSE; METAPNEUMOVIRUS; MORTALITY; OUTCOME ASSESSMENT; PARAINFLUENZA VIRUS; PARAINFLUENZA VIRUS INFECTION; RABIES; RESPIRATORY SYNCYTIAL PNEUMOVIRUS; REVIEW; SEVERE ACUTE RESPIRATORY SYNDROME; SUBACUTE SCLEROSING PANENCEPHALITIS; SWELLING; UNITED STATES; VIRUS INFECTION; INTRAVENOUS DRUG ADMINISTRATION; METHODOLOGY; TREATMENT OUTCOME;

ANTIVIRAL AGENTS; DRUG APPROVAL; DRUGS, INVESTIGATIONAL; HUMANS; INJECTIONS, INTRAVENOUS; RIBAVIRIN; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VIRUS DISEASES;

EID: 67549090006     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2009.05.2014     Document Type: Review

References (26)

1. Graci ID, Cameron CE. Mechanisms of action of ribavirin against distinct viruses. Rev Med Virol. 2006;16(1):37-48. (Pubitemid 43133592)
2. Rebetol [pacbe insert]. Kenilworth, NJ: Schering-Plough; December 2007.
3. Ribasphere [package insert]. Greenville, NC: Three Rivers Pharmaceuticals; April 2004.
4. Copegus [package insert]. Nutley, NJ: Roche; April 2008.
5. Virazole [package insert]. Aliso Viejo, CA: Valeant Pharmaceuticals International; April 2002. http://www.valeant.com/fileRepository/products/PI. Virazole-Inhalation%20solution%206gm-PI-Apr02.pdf. Accessed February 3, 2009.
6. US Department of Health and Human Services, US Food and Drug Administration. Code of Federal Regulations. Emergency Use of an Investigational New Drug (IND). Title 21, Part 312.36. Washington, DC: US Dept of Health and Human Services; 2008.
7. Us Department of Health and human Services, US Food and Drug Administration. Expanded Access to Investigational New Drugs for Treatment Use. Federal Register 71. December 14, 2006:75148-75149. Washington, DC: US Dept of Health and Human Services: 2006.
8. Investigational Drug Brochure. Virazol® (Ribavirin USP) Injection, 2004 edition.
9. US Food and Drug Administration. Annual Reports. Code of Federal Regulations. Title 21, Food and Drugs. Part 312.33. Silver Spring, MD: US Food and Drug Administration; 2008.
10. Neofytos D, Ojha A, Mookerjee B, et al. Treatment of adenovirus disease in stem cell transplant recipients with cidofovir. Biol Blood Marrow Transplant. 2007;13(1):74-81. (Pubitemid 46044089)
11. Feuchtinger T, Lang P, Handgretinger R. Adenovirus infection after allogeneic stem cell transplantation. Leuk Lymphoma. 2007; 48(2):244-255. (Pubitemid 46994874)
12. Refaat M, McNamara P, Teuteberg J, et al. Successful cidofovir treatment in an adult heart transplant recipient with severe adenovirus pneumonia. J Heart Lung Transplant. 2008;27(6):699-700.
13. Paduch DA. Viral lower urinary tract infections. Curr Urol Rep. 2007;8(4):324-335. (Pubitemid 47168315)
14. Huggins JW, Hsiang CM, Cosgriff TM, et al. Prospective, double-blind, concurrent, placebo-controlled clinical trial of intravenous ribavirin therapy of hemorrhagic fever with renal syndrome. J Infect Dis. 1991;164(6):1119-1127.
15. IS. Avendano M, Derkach P, Swan S. Clinical course and management of SARS in health care workers in Toronto: a case series. CMAJ. 2003;168(13):1649-1660. (Pubitemid 36801928)
16. Booth CM, Matukas LM, Tomlinson GA, et al. Clinical features and short-term outcomes of 144 patients with SARS in the greater Toronto area. JAMA. 2003;289(21):2801-2809. (Pubitemid 37430115)
17. Chan TY, Miu KY, Tsui CK, Yee KS, Chan MH. A comparative study of clinical features and outcomes in young and older adults with severe acute respiratory syndrome. J Am Geriatr Soc. 2004;52(8): 1321-1325. (Pubitemid 39038205)
18. Chapman LE, Mertz GJ, Peters CJ, et al. Intravenous ribavirin for hantavirus pulmonaiy syndrome: safety and tolerance during 1 year of open-label experience. Antivir Ther. 1999;4(4):211-219. (Pubitemid 30058021)
19. Lewinsohn DM, Bowden RA, Mattson D, Crawford SW. Phase I study of intravenous ribavirin treatment of respiratory syncytial virus pneumonia after marrow transplantation. Antimicrob Agents Chemother. 1996;40(11):2555-2557. (Pubitemid 26367642)
20. Lam CW, Chan MH, Wong CK. Severe acute respiratory syndrome: clinical atid laboratory manifestations. Clin Biochem Rev. 2004;25(2): 121-132.
21. Li N, Wang GF, Wu YF, et al. Side effects of glucocorticosteroids in the management of 1291 patients of SARS. Beijing Do Xue Xue Bao. 2004;36(5):519-524.
22. Knowles SR, Phillips FJ, Dresser L, Matukas L. Common adverse events associated with the use of ribavirin for severe acute respiratory syndrome in Canada. Clin Infect Dis. 2003;37(8):1139-1142. (Pubitemid 37323673)
23. Muller MP, Dresser L, Raboud J, et al; Canadian SARS Research Network. Adverse events associated with high-dose ribavirin: evidence from the Toronto outbreak of severe acute respiratory syndrome. Pharmacotherapy. 2007;27(4):494-503.
24. Tai DY. Pharmacologic treatment of SARS: current knowledge and recommendations. Ann Acad Med Singapore. 2007;36(6):438-443. (Pubitemid 47234397)
25. Forni AL, Schluger NW, Roberts RB. Severe measles pneumonitis in adults: evaluation of clinical characteristics and therapy with intravenous ribavirin. Clin Infect Dis. 1994;19(3):454-462. (Pubitemid 24286950)
26. Yazici Y. Some concerns about adverse event reporting in randomized clinical trials. Bull NYU Hosp Jt Dis. 2008;66(2):143-145. (Pubitemid 351898382)