Introduction - Uppsala Monitoring Centre

sales (Böttiger & Westerholm, 1973).
Withdrawn: there is a large variation in the reasons for withdrawal/restrictions.
Canada in 1963, Australia in 1965, Sweden in 1973, Norway in 1976, France,
Philippines (but can be used as a last resort, 2009), UK, Yemen, USA,
Zimbabwe, Colombia, Armenia and Syria in 1977, Kuwait in 1978, Italy and
Demark in 1979, Saudi Arabia in 1980 (anaphylactic shock), Argentina in
1981, Sudan and Bangladesh in 1982, Egypt in 1983 (anaphylactic shock),
Israel in 1985, Belgium, Malaysia and Germany (prescription only) in 1987,
Spain and Ghana in 1989, Netherlands in 1990, Switzerland and Sri Lanka in
1992, Thailand in 1994, Nepal in 1997, Syria, Yemen and Zimbabwe in 1998,
Sweden in 1999, Morocco, Armenia, Lithuania, and Colombia in 2000,
Pakistan in 1988, Brazil in 2005, Bahrain, Greece, Ireland, Mexico, Peru,
Singapore, India, Venezuela and Japan (injection only) in 2006, because of
agranulocytosis and anaphylaxis. Banned in Vietnam and Nigeria. It was
withdrawn in Sweden in 1974 due to an estimated incidence of
agranulocytosis of 1 in 3000 patients (Böttiger & Westholm, 1973) and then
the IAAA study put the excess risk at 1.1 cases per million for the combination
of Ulm, Berlin and Barcelona, but in the combination Israel, Budapest and
Hungary there was no excess risk (IAAAS, 1986) and therefore it was
reintroduced in Sweden in 1995 and finally withdrawn in 1999 because of the
data presented by Hedenmalm and Spigset showing a figure of 1: 1439 (CI
1:850–1: 4684) (Hedenmalm & Spigset, 2002).The Ministry of Health in Brazil
convened a conference in 2001 that decided that the risks of dipyrone are
similar, or even lower, than of other analgesic/antipyretic drugs available on
the market (Wong, 2002). Restricted in Germany in 1981 to treatment of
severe pain and colic, and high fever not controlled by other drugs. HAI:
banned it in 27 countries and restricted it in twelve.
Availability: Metamizole is still manufactured in many countries (at least 25), e.g.
Germany, France, Spain (1995), the Far East, Africa and Latin and South
America (Martindale): available in France, Germany, Thailand, Brazil, Turkey,
Czechoslovakia, Argentina, Finland, Hungary, Mexico, Russia, Italy, Sweden,
Belgium, South Africa, Austria, Venezuela, Spain, Poland, Israel, and
Hongkong. From other sources, which may not be so reliable: Romania,
Brazil, Bulgaria, India, and Costa Rica (1993). Still available in Indonesia both
as single drug (Pyronal) or combination with vitamins (Neurogesic) vitamins or
with vitamins caffeine, chlordiazepoxide and diazepam and caffeine
(Metaneuron).
Drug Lifespan: 42 years
Delay in recognition: 14 years
Delay in regulatory action: 28 years
Time span of withdrawals: 37 years