[e-drug] ISDB Press Release oseltamivir

E-DRUG: ISDB Press Release oseltamivir
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The International Society of Drug Bulletins
What is more dangerous to your health: flu or Tamiflu° (oseltamivir)?

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>
[details added by moderator]

E-DRUG: ISDB Press Release oseltamivir (2)
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Dear E-druggers

I would like to comment some as a contact person for
ISDB press release on Oseltamivir issued on the 2nd February 2007.

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).

Rokuro Hama MD
Kusuri-no-Check (a ISDB full member bulletin)
Rokuro <gec00724@nifty.com>

E-DRUG: ISDB Press Release oseltamivir (3)
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Dear all,

   I've just quickly read the WHO's 17th March 2006 "Advice on Use of Olseltamivir" available at:
   [1]http://www.who.int/csr/disease/avian_influenza/guidelines/useofosel
   tamivir2006_03_17A.pdf. I

   The info therein is quite considered, pointing to the limited experience in the use and effects of this product. The document also advises that WHO would be monitoring developments related to the use and safety of this product, and review its recommendations 'as information becomes available'

   I would expect therefore, that WHO is working towards updating its advice/recommendations accordingly, should there be firm information to that effect. As for the 'hype' related to the wider use of this product beyond current advice, surely that is beyond the responsibility of WHO. The above advice also states that the recommendation is
'... issued without any warranty of any kind either express or implied', and 'In no event shall WHO be liable for damages of an nature, arising out of the use of this advice'.

   I suspect and would hope that the info posted by Chris is available to WHO. In the long run, do we have a focus on alternatives to olseltamivir?

   Regards,

   Bonnie

Ministry Of Health,
Drug Supply Budget Line (DSBL),
Ndeke House,
P.O.Box 30205
Lusaka
Zambia
"BONFACE FUNDAFUNDA" <bcfunda@hotmail.com>