Introduction - Uppsala Monitoring Centre

60 cases of tumours in man in the literature by 1961 (Dahlgren 1961). The
increase estimated cumulative incidence for those exposed in the 1950s is
35–86% (Wetzels, 2007).
SED 1952 renal carcinoma, pulmonary carcinoma, liver carcinoma, and
aplastic anaemia
SED 1957 endothelial sarcoma in liver and spleen reported in 1956
SED 1967 said that its use was condemned in 1932 by the AMA Council on
Pharmacy and Chemistry because of the possibility of necrosis or malignant
change. The latent periods between administration and development of these
ADRs was 5 years for granulomas, 15 years for liver fibrosis and 20 years for
liver tumours.
Withdrawn: in France in 1936 and in the USA in 1964 (the FDA said that it was
unsafe). Withdrawn in the UK in 1955 because of carcinogenicity.
Availability: nil. Still available in 1967 (Granger, 1967)
Drug Lifespan: 8 years
Delay in recognition: 3 years
Delay in regulatory action: the delay of 28 years after being withdrawn in
France before withdrawal in the USA is difficult to understand.
Time span of withdrawals: 28 years
Comment: there was ample evidence of its toxicity by 1932 and the regulatory
authorities must have been relying on the radiologists to be aware of the
toxicity and reserve its use for those whose life expectancy ruled out a
problem with latent carcinogenicity. Selbie’s warning was ignored.
1930 Mercurothiolate Sodium (Thiomersal, Thiobactal)
Use: antiseptic
ADR: ‘the risks from thiomersal-containing vaccines are speculative and
inadequately quantified.’ (Bigham & Copes, 2005).
Withdrawn: in Malaysia in 1995 and in Brazil in 2001, USA, and European Union
in 1999 because of urothelial cancer, nephrotoxicity and peripheral neuropathy.
Availability: in the USA, Israel, France, Brazil, Spain, Australia, Chile, Italy,
Argentina, South Africa, Thailand, Venezuela and Mexico (Martindale). It is still
present in vaccines in 2008.
Drug Lifespan: 65 years
Delay in recognition: potential problems were recognised and investigated and
no convincing evidence found to ban its use.
Delay in regulatory action: none
Time span of withdrawals: 6 years
Comment: the general rule is Thiomersal free vaccines for rich countries and
Thiomersal containing vaccines for the developing world (Bigham & Copes, 2005).