Introduction - Uppsala Monitoring Centre

combinations with derivatives of amidopyrine and others with derivatives of
salicylic acid, some with antacid and another with Carisoprodol. viz) (Informasi
Spesialite Obat Indonesia, 2005) and Thailand (HAI, 2008). It is a dangerous
drug and should be used only when less toxic alternatives are unavailable
(Biscarini, 2000). It was still available in Fiji in 1986 combined with
amidopyrine and prednisolone.
Drug Lifespan: 28 years
Delay in recognition: 25 years
Delay in regulatory action: 12 years
Time span of withdrawals: 11 years
Comment: Venning said that the magnitude of the problem was underestimated
owing to underreporting. (Venning II,1983) Another example of a drug
remaining on the market for specific usage, but used for other indications in
poor countries. Reactions of this rarity are unlikely to be discovered by a
cohort study. Although oxyphenbutazone was taken off the market
phenylbutazone, which is almost identical as to its ADRs, remained on the
Canadian market (Biron, 1986). It is closely allied to amidopyrine so it was not
surprising that it caused agranulocytosis. It needs to be compared with the
other pyrazolones: dipyrone, aminopyrine and oxyphenbutazone.
1951 Diamthazole di-HCl (Dimazol, Asterol)
Use: a topical (powder, ointment and tincture) antifungal (tinea) agent
ADR: hepatotoxicity, neuropsychiatric and neurotoxic ADRs (Hitch & Raleigh,
1952). Tremor, visual hallucinations, disorientation, nystagmus, ataxia,
dysarthria and convulsions (Featherstone, 1952), vomiting, cyanosis,
mydriasis and disturbed respiration reported in 1957 (Christen & Jaccottet,
1957; Morton, 1960; Anon, 1957).
SED 1960: four infants had convulsions due to the ointment, as well as
tremor, ataxia, hallucinations and changes in behaviour.
SED 1958, SED 1962, SED 1966, SED 1968, SED 1972, SED 1976, SED
1980 and SED 1984: no mention
Withdrawn: in the USA and France in 1977, because of severe neurotoxic
reactions, their potential for misuse and the availability of safer alternative
products.
Availability: topical preparations of diamazole remain available in some 40
countries (WHO, 2003).
Drug Lifespan: 26 years
Delay in recognition: one year
Delay in regulatory action: 25 years
Comment: the seriousness of the ADRs may have been offset by their rarity.
The absorption of the agent will have depended on the amount used, and the