Introduction - Uppsala Monitoring Centre

Availability: nil
Drug Lifespan: 13 years
Delay in recognition: it had been known for more than a century that mercury
was absorbed through the skin.
Delay in regulatory action: 30 years
Comment: it is difficult to know why it was allowed on the market when it was
predictable. It is interesting to note that the Japanese despite their pale skins
used the drug sufficiently for it to be a problem.
1957 Oxyphenbutazone (Oxazolidin, Tanderil)
Use: antirheumatic and analgesic. One of the active metabolites of
phenylbutazone. A pyrazolone derivative
ADR: aplastic anaemia and agranulocytosis (see phenylbutazone). The
incidence of mortality was 3.8 per 100,000 (Inman, 1977). Inman gave the
incidence rate as 1 per 45,000 new(assumed) prescriptions of
phenylbutazone compared with 1 per 26,500 for oxyphenbutazone (Inman,
1977). The first case of thrombocytopenia was reported in 1961 (Armstrong
and Scherbel, 1961). A fatal case of agranulocytosis, thrombocytopenia and
hepatic necrosis was described in 1962 (Gaisford, 1962). The risk of
developing aplastic anaemia with oxyphenbutazone was 1: 124,000 or
approximately four times the risk from chance (Wallerstein et al., 1969).
SED 1964: granulocytopenia
Withdrawn: restricted in Japan to acute exacerbations of rheumatoid arthritis
and osteoarthritis in 1977; restricted in Austria, Ireland, Kuwait, Barbados,
Spain and withdrawn in France, Cyprus, Finland, Tunisia, United Arab
Emirates, Zimbabwe, Jordan and Bangladesh in 1984; licence revoked in the
UK in 1984, restricted in Germany and the Netherlands and withdrawn in the
USA, Canada, Ethiopia, Greece, Sweden, New Zealand and Chile in 1985;
withdrawn in Ghana, Oman and Turkey in 1986; withdrawn in Malaysia and
Hong Kong in 1987; restricted to prescription only in Belgium in 1988; and
withdrawn in Sri Lanka in 1992. Also withdrawn in Bahrain, Congo and Israel
and restricted in Italy, South Africa and Hungary. HAI: banned in 21 countries
and restricted in eleven.
Availability: still available in Indonesia (Sponderil)
Drug Lifespan: 20 years
Delay in recognition: 5 years
Delay in regulatory action: 15 years
Time span of restrictions: 15 years
Comment: as phenylbutazone and oxyphenbutazone are so similar there was
only need for one of them.