Aufgrund der Aktualität übernehmen wir den Pressetext der International Society of Drug Bulletins (ISDB) im Original. Wir bitten die Leserinnen und Leser um Verzeihung, dass der Text in englischer Sprache erscheint.

2 February 2007

In many countries such as Japan oseltamivir (Tamiflu®) is promoted for common flu. Oseltamivir has been stockpiled by more than 300 corporations, some governments in developed countries, as well as the World Health Organization (WHO), in case a new-type flu pandemic occurs.

There is some confusion between what is known of oseltamivir in treatment or prevention of common flu, and what is known of its effects in treatment or prevention of complications during a hypothetical new-type flu pandemic.

Most often flu is a mild and self-limited infection, and there is no evidence that oseltamivir reduces the frequency of serious flu complications, whether in healthy people or vulnerable populations. At most oseltamivir reduces flu symptoms by one day, which is not relevant.

There is no evidence that oseltamivir prevents flu complications in close contacts of flu infected patients during a seasonal outbreak.

So far avian flu can hardly be seen as a global public health problem. There is no evidence that oseltamivir is effective at preventing or curing complications during a new-type flu pandemic.

Oseltamivir commonly induces nausea and vomiting, and there is increasing evidence that oseltamivir may cause serious side effects, such as abnormal behaviour and sudden death from respiratory depression. The FDA warned about the possibility of neuropsychiatric side effects of oseltamivir following consistent reports, mostly from Japan, where oseltamivir is widely used (www.fda.gov/medwatch/safety/2006/safety06.htm#tamiflu).

Therefore ISDB calls on caregivers and the public to avoid using oseltamivir in common flu, due to increasing evidence that oseltamivir may cause more harm than good. Oseltamivir does not provide value for money in common flu.

ISDB calls on WHO to stop stockpiling oseltamivir, considering the absence of solid evidence that the drug could be helpful during a new-type flu pandemic. Stockpiling of oseltamivir by WHO is also seen to contribute to the hype surrounding the unwarranted use of oseltamivir (³An iatrogenic pandemic of panic² BMJ 2006; 332; 786-788).

Contact: Rokuro Hama
(gec00724@nifty.com)

International Society of Drug Bulletins (ISDB) www.isdbweb.org ISDB is a worldwide network of more 73 bulletins and journals on drugs and therapeutics that are financially and intellectually independent of pharmaceutical industry. The overall aim of ISDB is to encourage the rational use of drugs, to assist the development of independent drug bulletins in all countries and to facilitate co-operation amongst them.

Christophe Kopp
La Revue Prescrire
<Christophe.Kopp@wanadoo.fr>

Weiterführende Literatur:

This press released on the use of oseltamivir for seasonal flu and stockpiling is very important because harm and benefit ratio has been rapidly changing according to the new information from US (FDA [1,2]) and Japan (MHLW[3], The Informed Prescriber [4] and Kusuri-no-Check[5-8].

Adverse effects of oseltamivir include sudden deaths during sleep [2-8] and neuropsyciatric symptoms such as delirium and abnormal behavior[1-8], and even suicide[1].

For more details, please see the following references which are not on the press release.

References

1) FDA Sept. 20 2006 (Nov 16 2006) http://www.fda.gov/ohrms/dockets/ac/06/brie
fing/2006-4254b_09_01_
Tamiflu%20AE%20Review%202006%20Redacted_D060309_092.pdf

2) FDA Nov 18
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4180b_06_01_
Tamiflu%20AE_reviewed.pdf

3) Report of task force of MHLW for a study on symptoms during influenza (in Japanese) http://www.mhlw.go.jp/topics/2006/10/dl/tp1020-2.pdf

4) Hama R. New type of influenza-related encephalopathy or new adverse drug reaction? BMJ Rapid Response, 28 February 2005. http://bmj.bmjjou
rnals.com/cgi/eletters/328/7433/227#98374

5) Web-Kusuri-no-Check International No10 Feb 1, 2007 http://www.npojip.org/english/no10.html

6) Hama R. Limited benefit and potential harm of oseltamivir including sudden death and death from abnormal behavior
(26 November 2005). www.bmj.com/cgi/eletters/331/7526/1203-b

7) Hama R. Tamiflu induces abnormal behavior in the first day afternoon (1) The Informed Prescriber 21 (11): 110-116, 2000 (in Japanese), ibid 21 (12): 127-131, 2006 (in Japanese),

8) Hama R. Psycho-neurological adverse reactions to oseltamivir:
case series and discussion of causal relationship (under contribution).

Donnerstag, 08. Februar 2007

zurück

Zuletzt aktualisiert: Donnerstag, 08. Februar 2007