BMJ  2007;335:59 (14 July), doi:10.1136/bmj.39262.448877.BE

Letters

Oseltamivir's adverse reactions

Fifty sudden deaths may be related to central suppression

The first 150 words of the full text of this article appear below.

In his editorial on the association between oseltamivir phosphate (Tamiflu or oseltamivir-P) and neuropsychiatric disturbance in adolescents Maxwell says that the case is not proved but caution is advisable.¹ On 16 June 2007 the Japanese Ministry of Health Labour and Welfare announced that by 31 May 2007 it had received 1377 reports of adverse reactions since 2001, when marketing of oseltamivir started in Japan.²

Of these, 567 were serious neuropsychiatric cases, 211 showing abnormal behaviour. The number of deaths reported was 71. These are not only "adverse events" but also "adverse reactions" to oseltamivir because many doctors classed and reported them as probably related or that causality could not be ruled out. However, the ministry classed all but four as "rather negative," believing that the four were allergic in origin.

In addition to these 71 deaths, there were nine sudden deaths which the ministry did not recognise as adverse reactions.

. . . [Full text of this article]

Japan Institute of Pharmacovigilance, No 402 Osaka 2-3-2, Tennoji-ku Osaka, Japan 543-0062

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