Introduction - Uppsala Monitoring Centre

purpura, toxic hepatitis, and aplastic anaemia (Mauer, 1955).
In 1957 Venning reported a case of aplastic anaemia due to phenylbutazone.
He pointed out that regular white-cell counts are no safeguard against many
of its lethal complications (Venning, 1957).
SED 1960: agranulocytosis with loss of all cellular elements (1959)
The estimate of the incidence of death caused by agranulocytosis in the UK
was 2.2 per 100,000 with sex ratio in the over 65 years being males/females
1:5 (Inman, 1977). The IAAAS gave a figure of excess risk of 0.2 per million
(IAAAS, 1986).
By 1964 there had only been 7 published reports of aplastic anaemia
(McCarthy & Chalmers, 1964).
In 1965 The UK regulatory authorities (CSD) issued a warning concerning
bone marrow toxicity (Venning II, 1983).
By 1967 Dr PD Fowler of Geigy said in a personal communication to Dr G
Venning that the company had received 45 case reports (Venning II, 1983).
In 1977 The Committee on the Safety of Medicines said that they had
received reports of 188 deaths from aplastic anaemia or agranulocytosis
(aplastic anaemia 233, agranulocytosis 17) with an incidence of 1 in 50,000
patients the risk being greater for older patients (Inman, 1977).
In 1985 Ciba-Geigy’s view, according to the authors, was that the drug
continued to be valuable for selective use under medical supervision
(Herxheimer et al., 1985).
In 1986 the Canadian authorities wrote in a ‘Dear Doctor’ letter that
phenylbutazone should be restricted to use with ankylosing spondylitis and
acute gout (Biron, 1986).
Withdrawn: Jordan (1977), Bangladesh (1977), Ethiopia, Netherlands, Chile
(1985), Panama, Turkey, Ghana (1989), Sri Lanka (1992), Norway, United
Arab Emirates, Armenia (2000), Bahrein and Cyprus. HAI: banned in 12
countries.
Restrictions: restricted in Japan (use only for exacerbation of arthritis,
ankylosing spondylitis and acute gout) in 1977; Hungary, Ireland, Tunisia,
Argentina, Kuwait, Barbados, Zimbabwe, Spain and Congo in 1984, Greece,
Norway, Germany (use not to exceed one week for exacerbation of acute
rheumatism or acute gout), Iraq, United Arab Emirates, Paraguay, Hongkong,
Oman, New Zealand and Sweden in 1985, Turkey in 1976, Malaysia in 1987,
Belgium in 1988, also Australia, Austria, UK (use in ankylosing spondylitis
only), Israel, Italy (use not to exceed 10 days) and Philippines. It was
restricted to use hospital treatment of ankylosing spondylitis in Finland, UK,
Zimbabwe, Kuwait, New Zealand, and South Africa (Herxheimer et al., 1985).
HAI: restricted in 26 countries.
Availability: it is still found in many places including Indonesia (numerous