Is Oseltamivir (Tamiflu®) Safe? Re-examining the Tamiflu 'Ado' from Japan

Etsuji Okamoto


Expert Rev Pharmacoeconomics Outcomes Res. 2010;10(1):17-24. 

In This Article

Five-year View

The issue is whether the MHLW will revoke the warning against the use of oseltamivir for teenagers issued on 30 March 2007 and the answer is no. Since none of the project commissioned by the MHLW drew firm conclusions, although preponderance of evidence had suggested in favor of oseltamivir, there will not be any more evidence reliable enough to revoke the warning. In the summer of 2009, Japan was infested with the novel influenza A/H1N1, which tends to affect young people and oseltamivir is already in wide use even for teenagers without high-risk. Despite increased use of oseltamivir, no significant increases of NPAEs has been observed so far.

As for the potential risk of sudden death, it may be resolved with firm evidence within 5 years. Japan established a national database in 2008 collecting all medical and pharmaceutical claims, which approximates 1.7 billion claims annually. Given the sheer size of database, it may be possible to detect if there is any significant difference in the incidence of sudden death after ingestion of oseltamivir if the database is properly used.


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