E-drug: Re: Dipyrone/metamizole withdrawn in Sweden
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Further to my mail yesterday. here is an English translation of the Dear
Doctor letter. A Spanish translation will follow.
Regards
Staffan Svensson
kfss@mailer.mednet.gu.se
Important message
Drug withdrawal
Sender: Box 17608, 118 92 Stockholm Sweden
Doctor XXX XXX
To all physicians/dentists
Withdrawal of Novalgin (metamizole), 500 mg tablets and 500 mg/ml
intravenous solution.
In agreement with the Medical Product Agency, Hoechst Marion Roussel Ltd has
decided that all sale of Novalgin in Sweden is to be stopped from 28 April
1999. Any stock in pharmacies, hospital wards and clinics will be withdrawn.
The decision is based on a larger than expected number of reports of
agranulocytosis in Sweden since 1996.
Novalgin is licensed under the following indication:
'Short-term management of acute, moderate to severe pain secondary to tissue
damage, eg after surgical procedures, and colic pain, eg from urinary or
biliary tract.'
Novalgin had been on the Swedish market from 1934 until 1974, when it was
withdrawn due to agranulocytosis, the incidense of which was an estimated
1/3 000 (ref Bottiger LE, Westerholm B (1973) BMJ;568:339-43).
In 1995, Novalgin was re-licensed under the indication mentioned above,
partly based on the results of a large epidemiological study that showed a
considerably reduced risk of agranulocytosis compared with previous
estimates (ref The International Agranulocytosis and Aplastic Anaemia Study
(1986) JAMA, Oct 3; 256;13:1749-57). [The data sheet was posted on E-drug
during a previous round, moderator]. Since the re-introduction of the
product on the Swedish market in 1996, seven cases of agranulocytosis have
been reported to the Medical Product Agency. Of these spontaneous reports,
six cases occurred after use of tablets. The judgement of the Medical
Product Agency is that the actual incidense is
1/1 700, which is higher than expected.
Prescribers should urge patients to discontinue metamizole and propose
alternative treatment options. Cases of bone-marrow affection in relation to
Novalgin use should be reported to the Medical Product Agency according to
normal routines.
For any additional queries, please contact Customer Support, Hoechst Marion
Roussel Ltd.
With best regards,
Anders Nilsson, Senior lecturer
Medical director
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