Safety and tolerability of a 6-week course of oseltamivir prophylaxis for seasonal influenza in children

Keith Reisinger, Daniel Shu, Lisa Cupelli, Isaac Marcadis, Regina Dutkowski, Keith Reisinger, Daniel Shu, Lisa Cupelli, Isaac Marcadis, Regina Dutkowski

Abstract

In an open-label study, 49 children aged 1-12 years received oseltamivir (30-75 mg once daily depending on bodyweight) for 6 weeks for influenza prophylaxis. Seventeen participants reported 22 adverse events (AEs); in three participants, AEs were considered probably drug related (nausea or vomiting). No serious AEs were reported. The tolerability profile was similar to pooled safety data from treatment studies (duration of 5 days) in children.

Trial registration: ClinicalTrials.gov NCT00412555.

© 2012 Blackwell Publishing Ltd.

References

    1. Heikkinen T. Influenza in children. Acta Paediatr 2006; 95:778–784.
    1. Hurwitz ES, Haber M, Chang A et al. Studies of the 1996–1997 inactivated influenza vaccine among children attending day care: immunologic response, protection against infection, and clinical effectiveness. J Infect Dis 2000; 182:1218–1221.
    1. Heikkinen T, Silvennoinen H, Peltola V et al. Burden of influenza in children in the community. J Infect Dis 2004; 190:1369–1373.
    1. Peltola V, Ziegler T, Ruuskanen O. Influenza A and B virus infections in children. Clin Infect Dis 2003; 36:299–305.
    1. Lahti E, Peltola V, Virkki R, Ruuskanen O. Influenza pneumonia. Pediatr Infect Dis J 2006; 25:160–164.
    1. Tsolia MN, Logotheti I, Papadopoulos NG et al. Impact of influenza infection in healthy children examined as outpatients and their families. Vaccine 2006; 34:5970–5976.
    1. Toovey S. Influenza‐associated central nervous system dysfunction: a literature review. Travel Med Infect Dis 2008; 6:114–124.
    1. Centers for Disease Control Prevention (CDC) . Influenza vaccination coverage among children and adults – United States. 2008–09 influenza season. Morb Mortal Weekly Rep 2009; 58:1091–1095.
    1. Poehling KA, Edwards KM, Weinberg GA et al. The underrecognized burden of influenza in young children. N Engl J Med 2006; 355:31–40.
    1. Centers for Disease Control Prevention (CDC) . Update: influenza activity, United States, August 30, 2009 – January 9, 2010. Morb Mortal Weekly Rep 2010; 59:38–43.
    1. Health Protection Agency . Pandemic (H1N1) 2009 in England: an overview of initial epidemiological findings and implications for the second wave. Available from: .
    1. Hayden FG, Atmar RL, Schilling M et al. Use of the selective oral neuraminidase inhibitor oseltamivir to prevent influenza. N Engl J Med 1999; 341:1336–1343.
    1. Peters PH Jr, Gravenstein S, Norwood P et al. Long‐term use of oseltamivir for the prophylaxis of influenza in a vaccinated frail older population. J Am Geriatr Soc 2001; 49:1025–1031.
    1. 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.
    1. Chik KW, Li CK, Chan PK et al. Oseltamivir prophylaxis during the influenza season in a paediatric cancer centre: prospective observational study. Hong Kong Med J 2004; 10:103–106.
    1. Wallensten A, Oliver I, Lewis D, Harrison S. Compliance and side effects of prophylactic oseltamivir treatment in a school in South West England. Euro Surveill 2009; 14:19285.

Source: PubMed

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