E-DRUG: Dipyrone in Sweden and elsewhere (contd.)
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The discussion about dipyrone must be seen in a broader context
than its questionable re-licensing in Sweden. Additional data
should be taken into consideration:
Dipyrone is still banned in many countries, and its use severely
restricted in others. That shows that a number of well known
authorities still think that people can live without this drug
and that are less risky alternatives. It is by no means an
essential therapeutic.
No one can justify the use of dipyrone combinations. Dipyrone is
a highly immunogenic agent, causing not only agranulocytosis but
also other immune diseases such as pneumonitis, aleovitis,
hepatitis, Lyell syndrome etc. The leading disease is vasculitis,
the often fatal form of allergic shock syndrome.
There is little comparable data available about the overall risk
of dipyrone and other painkillers. The International
Agranulocytosis and Aplastic Anemia Study (IAAAS - Boston) study
which is often referred to was sponsored by the world's largest
supplier of dipyrone, Hoechst. The incidence of dipyrone-induced
agranulocytosis is not one in one million user-weeks as the IAAAS
suggests, but 1 in about 25,000 users per year, as has been reported
at the hearing of the German health authorities on dipyrone in 1986.
The scientific discussion about dipyrone was summarised by BUKO and
HAI-Europe some years ago. Anyone interested can ask HAI for a copy
of 'Dipyrone - a drug NO one needs' (email hai@hai.antenna.nl).
The situation in Germany is as follows:
In April 1987 most combinations were banned. In February 1990 the
German authority (BGA) finally withdraw all licenses for
dipyrone-combinations.
The use of dipyrone as single substance has been severely restricted
1 March 1987 to the treatment of acute severe pain after injuries or
surgery, colics, tumor pain and other acute severe states of pain,
if other therapeutic management is insufficient. Fever may only be
treated with dipyrone if all other therapeutic measures fail. The
BGA took the IAAAS study into account in its decision and judgement.
The study design chosen in the IAAAS is not suitable to yield data
about absolute risks. All these measures have been taken on the
risk intervention scheme (Stufenplan). A final assessment about
dipyrone effects and risks based on the 1978 drugs law is still
pending. Dipyrone has prescription only status.
Dipyrone in Sweden:
The basis for the license in Sweden is public. The only study
which takes reference to the risk of agranulocytosis is the IAAAS
again. The rate of other unwanted effects are based on only 2004
and 668 patients respectively (Overall Conclusion II, p.5f). One
really wonders whether there are no other good studies on the
potential risks of dipyrone after many years of use? It would
indeed be very interesting to discuss the basis of the Swedish
decision. Some experts claim that the reason for the re-licensing
of dipyrone in Sweden was that the country after joining the
European Union is lowering its regulatory standards to the
deplorable low quality of other member states of the EU.
Another concern is: Who gives what information? Are people
involved in this discussion really independent from Hoechst
Marion Roussel?
Jorg Schaaber
BUKO Pharma-Kampagne
August-Bebel-Str. 62
D-33607 Bielefeld, Germany
Tel. +49-521-60550 Fax -63789
Email: 100270.272@compuserve.com
Homepage: www.epo.de/bukopharma/
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