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Oseltamivir and early deterioration leading to death: A proportional mortality study for 2009A/H1N1 influenza

Article type: Research Article

Authors: Hama, Rokuro | Jones, Mark | Okushima, Hiroki | Kitao, Masahiro | Noda, Narumi | Hayashi, Keiji | Sakaguchi, Keiko

Affiliations: Non-profit Organization “Japan Institute of Pharmacovigilance (Kusuri-no-Check)”, Osaka, Japan | School of Population Health, The University of Queensland, Brisbane, Australia | School of Medicine, University of Osaka, Osaka, Japan | Hayashi Pediatric Clinic, Osaka, Japan

Note: [] Address for correspondence: Rokuro Hama, Chairperson, Non-profit Organization “Japan Institute of Pharmacovigilance (Kusuri-no-Check)”, Osaka, Japan. Part time lecturer, School of Medicine, University of Osaka, Room 902, Ueshio 3-2-17, Tennoji-ku, Osaka 543-0002, Japan. E-mail: gec00724@nifty.com.

Keywords: Oseltamivir, sudden death, adverse effect, proportional mortality study, 2009A/H1N1 influenza

DOI: 10.3233/JRS-2011-0545

Journal: International Journal of Risk & Safety in Medicine, vol. 23, no. 4, pp. 201-215, 2011

Published: 2011
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Abstract

Objective: To examine the epidemiological association between sudden deterioration leading to death and Tamiflu use. Design: Proportional mortality study. Setting: Japan. Participants: 162 deaths without deterioration before the first consultation among all 198 deaths of mostly confirmed 2009A/H1N1 influenza. Population at risk: Age-specific population of influenza patients prescribed Tamiflu and Relenza. Main outcome measure: Age-stratified pooled odds ratio (OR) for early (within 12 hours) deterioration and overall death of Tamiflu prescribed to Relenza prescribed patients. Results: Of 119 deaths after Tamiflu was prescribed, 38 deteriorated within 12 hours (28 within 6 hours), while of 15 deaths after Relenza, none deteriorated within 12 hours. Pooled OR for early deterioration and overall death were 5.88 (95% CI: 1.30 to 26.6, p = 0.014) and 1.91 (p = 0.031) respectively. Baseline characteristics including risk factors did not contribute to early deterioration after Tamiflu use. Conclusions: These data suggest Tamiflu use could induce sudden deterioration leading to death especially within 12 hours of prescription. These findings are consistent with sudden deaths observed in a series of animal toxicity studies, several reported case series and the results of prospective cohort studies. From “the precautionary principle” the potential harm of Tamiflu should be taken into account and further detailed studies should be conducted.

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