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E-DRUG: Dipyrone/metamizole withdrawn in Sweden


  • From: "Staffan Svensson" <kfss@mailer.mednet.gu.se>
  • Date: Mon, 3 May 1999 15:52:53 -0400 (EDT)

E-drug: Dipyrone/metamizole withdrawn in Sweden
----------------------------------------------------------

All formulations of dipyrone/metamizole was withdrawn from the Swedish
market on April 28th 1999, according to a 'Dear Doctor' letter sent from
Hoechst Marion Roussel (HMR) to all Swedish physicians and dentists last week.

As was pointed out in a recent e-drug posting (April 9th) from Andrew
Herxheimer (citing a letter from Prof Dr. P.S. Schonhofer), the Swedish
re-licensing of dipyrone/metamizole - HMR's Novalgin - was based on a
re-calculation of risks from the International Agranulocytosis and Aplastic
Anemia Study (IAAAS), published in 1986. Novalgin was withdrawn in 1974 and
re-licensed in 1996 for short-term use in acute pain of moderate to severe
intensity, and was intended for in-hospital use.

According to the Swedish Medical Product Agency (MPA), there have been 6-7
cases of agranulocytosis in dipyrone/metamizole users since the re-licensing
(personal communication May 03 1999).

In 1997, I tried to get hold of the product monography from the MPA, but
wasn't allowed access. Instead, I was sent a copy of the IAAAS. The official
MPA letter regarding the re-licensing gives no detail as to why they were
convinced of the safety of the drug.

Please contact me if you want a copy or translation of the 'Dear Doctor' letter!

As a matter of concern, I noted last autumn that dipyrone/metamizol was for
sale (OTC!) in a local pharmacy in Hiiumaa, Estonia...

Staffan Svensson
Dep. of Clinical Pharmacology
SU/Sahlgrenska
Gothenburg
Sweden
staffan.svensson@pharm.gu.se

[Note from moderator: Very interesting indeed! But Staffan, if dipyrone had
been available OTC only in Estonia... The fact is that under names such as
dipyrone, Novalgin and Analgin it is available OTC in all the countries of
CEE and NIS and probably in many other countries. And amongst the top ten
drugs in sale in many countries! Kirsten Myhr]



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