A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy

Summary

The primary research question of this study is: Does the pharmacokinetics of oseltamivir after a single oral dose differ between the pregnant and non-pregnant women?

Timeline

Start

2009-04

Primary completion

2010-09

Completion

2010-09

Publications

• Background Advisory Committee on Immunization Practices; Smith NM, Bresee JS, Shay DK, Uyeki TM, Cox NJ, Strikas RA. Prevention and Control of Influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006 Jul 28;55(RR-10):1-42.
• Background Neuzil KM, Reed GW, Mitchel EF, Simonsen L, Griffin MR. Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol. 1998 Dec 1;148(11):1094-102. doi: 10.1093/oxfordjournals.aje.a009587.
• Background Irving WL, James DK, Stephenson T, Laing P, Jameson C, Oxford JS, Chakraverty P, Brown DW, Boon AC, Zambon MC. Influenza virus infection in the second and third trimesters of pregnancy: a clinical and seroepidemiological study. BJOG. 2000 Oct;107(10):1282-9. doi: 10.1111/j.1471-0528.2000.tb11621.x.
• Background Cox S, Posner SF, McPheeters M, Jamieson DJ, Kourtis AP, Meikle S. Hospitalizations with respiratory illness among pregnant women during influenza season. Obstet Gynecol. 2006 Jun;107(6):1315-22. doi: 10.1097/01.AOG.0000218702.92005.bb.
• Background Cox S, Posner SF, McPheeters M, Jamieson DJ, Kourtis AP, Meikle S. Influenza and pregnant women: hospitalization burden, United States, 1998-2002. J Womens Health (Larchmt). 2006 Oct;15(8):891-3. doi: 10.1089/jwh.2006.15.891.
• Background Lindsay L, Jackson LA, Savitz DA, Weber DJ, Koch GG, Kong L, Guess HA. Community influenza activity and risk of acute influenza-like illness episodes among healthy unvaccinated pregnant and postpartum women. Am J Epidemiol. 2006 May 1;163(9):838-48. doi: 10.1093/aje/kwj095. Epub 2006 Mar 22.
• Background ACOG Committee on Obstetric Practice. ACOG committee opinion number 305, November 2004. Influenza vaccination and treatment during pregnancy. Obstet Gynecol. 2004 Nov;104(5 Pt 1):1125-6.
• Background Garcia-Sastre A, Whitley RJ. Lessons learned from reconstructing the 1918 influenza pandemic. J Infect Dis. 2006 Nov 1;194 Suppl 2:S127-32. doi: 10.1086/507546.
• Background Webster RG, Govorkova EA. H5N1 influenza--continuing evolution and spread. N Engl J Med. 2006 Nov 23;355(21):2174-7. doi: 10.1056/NEJMp068205. No abstract available.
• Background Ferguson NM, Cummings DA, Cauchemez S, Fraser C, Riley S, Meeyai A, Iamsirithaworn S, Burke DS. Strategies for containing an emerging influenza pandemic in Southeast Asia. Nature. 2005 Sep 8;437(7056):209-14. doi: 10.1038/nature04017. Epub 2005 Aug 3.
• Background Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med. 2005 Sep 29;353(13):1363-73. doi: 10.1056/NEJMra050740. No abstract available.
• Background Dutkowski R, Thakrar B, Froehlich E, Suter P, Oo C, Ward P. Safety and pharmacology of oseltamivir in clinical use. Drug Saf. 2003;26(11):787-801. doi: 10.2165/00002018-200326110-00004.
• Background Health Sciences Authority. Product Safety Alert: new preclinical findings on Oseltamivir. March 2004. (Accessed November 27, 2006 at: http://www.hsa.gov.sg/docs/safetyalert_oseltamivir_March04.pdf.)
• Background Hayden FG, Treanor JJ, Betts RF, Lobo M, Esinhart JD, Hussey EK. Safety and efficacy of the neuraminidase inhibitor GG167 in experimental human influenza. JAMA. 1996 Jan 24-31;275(4):295-9.
• Background Massarella JW, He GZ, Dorr A, Nieforth K, Ward P, Brown A. The pharmacokinetics and tolerability of the oral neuraminidase inhibitor oseltamivir (Ro 64-0796/GS4104) in healthy adult and elderly volunteers. J Clin Pharmacol. 2000 Aug;40(8):836-43. doi: 10.1177/00912700022009567.
• Background Ward P, Small I, Smith J, Suter P, Dutkowski R. Oseltamivir (Tamiflu) and its potential for use in the event of an influenza pandemic. J Antimicrob Chemother. 2005 Feb;55 Suppl 1:i5-i21. doi: 10.1093/jac/dki018.

Drugs

Indications