23 June 2008

Web-Kusuri-no-Check International No11

"Fatal neuropsychiatric adverse reactions to oseltamivir:
 case series and overview of causal relationships"

By Rokuro Hama M.D. (Chairperson, Kusuri-no-Check)

is published in

The International Journal of Risk & Safety in Medicine 20 (2008) 5-36. [1]
DOI 10:3223/JRS-2008-0431 (IOS Press: free for abstract)

The full paper is available on this website (full paper PDF) (erratum

Kusuri-no-check has analyzed and investigated the causality link between oseltamivir (Tamiflu) and serious neuropsychiatric adverse reactions, including sudden deaths and accidental deaths due to abnormal behavior, since February 2005 when we first warned about this possibility.

Rokuro Hama (Chairperson, Kusuri-no-Check) has published an overview of the safety aspects of oseltamivir in the latest issue of The International Journal of Risk & Safety in Medicine 20 (2008) 5-36. [1]

This paper adds the following three major points to earlier reports: this is the first original paper presenting a case series of fatal or near fatal adverse reactions to Tamiflu; it is also the first paper overviewing the full spectrum of adverse reactions to Tamiflu, and the first paper discussing the causality and underlying mechanisms of the full spectrum of reactions to Tamiflu (from "3.13. What this paper adds to earlier reports": pp30-31).

Professor Chris J. van Boxtel wrote in his editorial [2]:

"As editor it is a pleasure for me to remind the reader that with this first issue of Volume 20 we commemorate the fact that it is 20 volumes ago that the founding editor of this journal, the esteemed Dr. M.N.G. Dukes, launched The International Journal of Risk and Safety in Medicine."

"We celebrate this anniversary with a double issue which features the first in depth review of the safety aspects of oseltamivir. And for making a risk-benefit analysis for this antiviral agent, such a review is timely, given the fact that the United States and many other countries have been stockpiling oseltamivir in the face of the risk that avian flu will spark a pandemic. "

"Enough about the effectiveness of oseltamivir for the treatment of influenza A infections. What can we say about its safety? Nausea and vomiting are the most commonly reported adverse events and Roche denies any dangerous side effects of its drug. However, there are concerns that oseltamivir may cause dangerous psychological side effects in some people. These concerns have focused on teenagers, but problems have also been reported in children and adults." - - - "In 2007, the Ministry warned that oseltamivir should not be given to children aged 10 to 19 - - -"

"The details of this occasionally fatal neurotoxicity can be read in this issue of the Journal."

He concluded:

"When we keep all this in mind we inevitably have to come to the conclusion that the final question has to be "are we betting on a crippled horse?"

We hope this paper could help not only health professionals and the public, but also regulatory authorities worldwide to make rational and safe decisions when dealing with oseltamivir.

References:

  1. Hama R, Fatal neuropsychiatric adverse reactions to oseltamivir:  case series and overview of causal relationships. The International Journal of Risk & Safety in Medicine 20 (2008) 5-36.
    Abstract
    Full paper (PDF)
    Erratum
  2. van Boxtel CJ. Editorial. The International Journal of Risk & Safety in Medicine 20 (2008) 1-3.