Introduction - Uppsala Monitoring Centre

were fatal (Adams & Perry, 1958); UK in 1961, Canada in 1963, Sweden in
1976, France in 1978 and Cyprus in 1980. Also withdrawn in Australia,
Finland, Norway and Venezuela. HAI: banned in 9 countries.
Availability: it is still available in some countries.
Drug Lifespan: 5 years
Delay in recognition: 5 years
Delay by the company: four days
Time span of withdrawals: 22 years
Comment: the prompt action by Sandoz was excellent, but how was it still
available in the UK, France, Canada, Sweden and Cyprus?
1954 Diiododiethyltin/isolinoleic acid ester (Stalinon)
Introduced in France.
Use: treatment for staphylococcal infections.
ADR: in 1954 triethyltin was shown to remarkably neurotoxic (Stoner et al., 1955)
Cerebral oedema–headache, photophobia, vomiting and drowsiness due to
raised intracranial pressure, and death occurring in 4-10 days (Le Quesne,
1981).
The intended dose used for toxicity testing should have been 50 mgm, but
due to an error, they used only 3 mgm and the resulting absence of toxicity
persuaded them to market a product containing 15 mgm per capsule. The
responsible pharmacist was sent to prison for two years and the company
held liable (D’Arcy & Griffin, 1986). There were no cases of poisoning for 6–
7 months, which, it was suggested, was because organic tin salts have a
delayed effect (HP, 1958). It was known that triethyltin was very neurotoxic
and Stalinon contained a variable amount of triethyltin as an impurity (Le
Quesne, 1981).
Withdrawn: in France in 1957 because 110 patients died out of the 290 patients
affected (Le Quesne, 1981)
Availability: Nil
Drug Lifespan: 3 years
Delay in recognition: none
Delay in regulatory action: 3 years
Comment: an error by the pharmaceutical company plus a delayed ADR meant
the drug remained on the market too long.
1954 Glutethimide (Doriden)
Use: hypnotic and sedative
ADR: acute glaucoma, dependence and abuse (Sramek & Khajawall, 1982). The
first case of dependence was reported in 1957(Rogers, 1958) and of addiction
in 1960 (Cohen, 1960).