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WHO downgrades status of oseltamivir

BMJ 2017; 358 doi: (Published 12 July 2017) Cite this as: BMJ 2017;358:j3266

This article has a correction. Please see:

  1. Mark H Ebell, professor of epidemiology
  1. College of Public Health, University of Georgia, Athens, GA, USA
  1. ebell{at}

Important lessons from the Tamiflu story

Oseltamivir (Tamiflu) was approved by the US Food and Drug Administration in 1999 for the treatment of uncomplicated influenza within 48 hours of the onset of symptoms. The manufacturer’s press release stated that the drug was studied in two randomised trials enrolling a total of 849 patients with influenza and reported a 1.3 day mean reduction in the duration of symptoms.1 The drug was described as safe, with less than 1% of patients discontinuing it because of adverse effects. It was approved by the European Medicines Agency in 2002.2

On the basis of these limited (and ultimately revealed as incomplete) data, governments acted. Concerned about a possible outbreak of avian influenza, as well as the H1N1 pandemic in 2009, the UK government stockpiled oseltamivir at a cost of over £600m (€680m; $770m) from 2006 to 2014. Similarly, the US government has spent over $1.5bn stockpiling the drug, based on recommendations from the Centers for Disease Control and Prevention (CDC).3 And in 2010, in the wake of the worldwide pandemic of H1N1 influenza, oseltamivir was added to the World Health Organization’s list of essential medications.4 This list is intended to guide decisions on …

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