International Journal of Antimicrobial Agents
Volume 35, Issue 5 , Pages 461-467 , May 2010

Safety and pharmacokinetics of oseltamivir at standard and high dosages

  • R. Dutkowski

      Affiliations

    • Hoffmann-La Roche Inc., Nutley, NJ, USA
  • ,
  • J.R. Smith

      Affiliations

    • F. Hoffmann-La Roche Ltd., PBMT Bldg 74/3O 104, CH-4070 Basel, Switzerland
    • Corresponding Author InformationCorresponding author. Tel.: +41 61 688 2489; fax: +41 61 687 2239.
  • ,
  • B.E. Davies

      Affiliations

    • Hoffmann-La Roche Inc., Nutley, NJ, USA

Received 15 October 2009 ,Accepted 26 December 2009.

References 

  1. Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med. 2005;353:1363–1373
  2. He G, Massarella J, Ward P. Clinical pharmacokinetics of the prodrug oseltamivir and its active metabolite Ro 64-0802. Clin Pharmacokinet. 1999;37:471–484
  3. World Health Organization. Clinical management of human infection with avian influenza A (H5N1) virus. Geneva, Switzerland: WHO; 2007. http://www.who.int/csr/disease/avian_influenza/guidelines/ClinicalManagement07.pdf [accessed 21 December 2009].
  4. Abdel-Ghafar AN, Chotpitayasunondh T, Gao Z, Hayden FG, Nguyen DH, de Jong MD, et al. Update on avian influenza A (H5N1) virus infection in humans. N Engl J Med. 2008;358:261–273
  5. World Health Organization. WHO guidelines for pharmacological management of pandemic (H1N1) 2009 influenza and other influenza viruses. Geneva, Switzerland: WHO; 2009. http://www.who.int/entity/csr/resources/publications/swineflu/h1n1_guidelines_pharmaceutical_mngt.pdf [accessed 1 September 2009].
  6. Dutkowski R, Thakrar B, Froehlich E, Suter P, Oo C, Ward P. Safety and pharmacology of oseltamivir in clinical use. Drug Saf. 2003;26:787–801
  7. Nicholson KG, Aoki FY, Osterhaus AD, Trottier S, Carewicz O, Mercier CH, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Lancet. 2000;355:1845–1850
  8. Treanor JJ, Hayden FG, Vrooman PS, Barbarash R, Bettis R, Riff D, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. JAMA. 2000;283:1016–1024
  9. Funck-Brentano C, Jaillon P. Rate-corrected QT interval: techniques and limitations. Am J Cardiol. 1993;72:17B–22B
  10. Wattanagoon Y, Stepniewska K, Lindegardh N, Pukrittayakamee S, Silachamroon U, Piyaphanee W, et al. Pharmacokinetics of high-dose oseltamivir in healthy volunteers. Antimicrob Agents Chemother. 2009;53:945–952
  11. Yap YG, Camm J. Risk of torsades de pointes with non-cardiac drugs. Doctors need to be aware that many drugs can cause QT prolongation. BMJ. 2000;320:1158–1159
  12. Kligfield P, Gettes LS, Bailey JJ, Childers R, Deal BJ, Hancock EW, et al. Recommendations for the standardization and interpretation of the electrocardiogram: part I: the electrocardiogram and its technology: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee. Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society: endorsed by the International Society for Computerized Electrocardiology. Circulation. 2007;115:1306–1324
  13. Casscells SW, Granger E, Kress AM, Linton A, Madjid M. Use of oseltamivir after influenza infection is associated with reduced incidence of recurrent adverse cardiovascular outcomes among military health system beneficiaries with prior cardiovascular disease. Circ Cardiovasc Qual Outcomes. 2009;2:108–115
  14. Meier CR, Jick SS, Derby LE, Vasilakis C, Jick H. Acute respiratory-tract infections and risk of first-time acute myocardial infarction. Lancet. 1998;351:1467–1471
  15. Smeeth L, Thomas SL, Hall AJ, Hubbard R, Farrington P, Vallance P. Risk of myocardial infarction and stroke after acute infection or vaccination. N Engl J Med. 2004;351:2611–2618
  16. Madjid M, Miller CC, Zarubaev VV, Marinich IG, Kiselev OI, Lobzin YV, et al. Influenza epidemics and acute respiratory disease activity are associated with a surge in autopsy-confirmed coronary heart disease death: results from 8 years of autopsies in 34,892 subjects. Eur Heart J. 2007;28:1205–1210
  17. Housworth J, Langmuir AD. Excess mortality from epidemic influenza, 1957–1966. Am J Epidemiol. 1974;100:40–48
  18. Alling DW, Blackwelder WC, Stuart-Harris CH. A study of excess mortality during influenza epidemics in the United States, 1968–1976. Am J Epidemiol. 1981;113:30–43
  19. The National Institute for Health and Clinical Excellence. Amantadine, oseltamivir and zanamivir for the treatment of influenza (review of existing guidance No. 58). London, UK: NICE; 2009. http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11774 [accessed 21 December 2009].
  20. Centers for Disease Control and Prevention (CDC). Neurologic complications associated with novel influenza A (H1N1) virus infection in children—Dallas, Texas, May 2009. MMWR Morb Mortal Wkly Rep 2009;58:773–8.
  21. Toovey S, Rayner C, Prinssen E, Chu T, Donner B, Thakrar B, et al. Assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: a comprehensive review. Drug Saf. 2008;31:1097–1114

PII: S0924-8579(10)00038-5

doi: 10.1016/j.ijantimicag.2009.12.023

International Journal of Antimicrobial Agents
Volume 35, Issue 5 , Pages 461-467 , May 2010