Introduction - Uppsala Monitoring Centre

cutaneous sarcoidosis, erythema multiforme, graft vs host disease,
Jessner’s infiltrates, uremic pruritus. Possibly effective in Kaposi’s sarcoma,
lichen planus, melanoma and pyoderma gangrenosum.
Drug Lifespan: 3 years for original indications
Delay in recognition: one year
Delay in regulatory action: none
Time span of withdrawals: 2 years
Comment: during the three years after thalidomide was approved in West
Germany on 1 st October 1957 and before it was submitted to the FDA on 12 th
September 1960 the first case of polyneuritis was reported to the company on
the 3 rd October 1959 (Sjöström & Nilsson, 1972), but Dr Burley of the Distillers
Company, says that the first possible case of peripheral neuritis was reported
on 10 th January 1960 and that 6 th case on 9 th August 1960 and further that the
literature was modified to warn of the neuritis in September 1960 (Burley,
1988). One wonders whether this difference was due to the use of different
terminology. Sjöström and Nilsson said that by the end of 1960 the company
had received over 100 reports of cases of severe polyneuritis. The Florence
letter of 31 st December 1960 gave the FDA warning of what was to come. The
drug had been by rejected by France and East Germany; the latter because of
its neurotoxicity, lack of extensive animal tests and clinical investigations and
inadequacy of the scientific results that were provided by the company (Shah,
2001). The earlier accounts reported 5 cases (Burley, 1988), but on
reintroduction that increased to 25% (Knopp et al., 1983) and a further paper
suggests 50% (Amelung & Püntmann, 1966). It is, in my opinion, likely that
had the company declared all the cases of peripheral neuritis as and when
they occurred the drug would have been taken off the market earlier (see
1961).
1956 Mercury Amide HCl
‘precipité blanc’ [White precipitate] or Chloramidure de mercure (Crème des 3
fleurs d’orient or Any creme) [Cream from three oriental flowers]
Use: depigmentation of the skin
ADR: mercury poisoning in children, unborn and neonates. This particular drug
was not mentioned in SED.
Withdrawn: in Japan in 1969; in France and Oman in 1986; and in Canada in
1997 (‘Diana de Beauté’ composed of ammoniated mercury, bismuth
subnitrate and salicylic acid). It was reformulated with méquinol in France
(Vidal, 2008). The AFSSAPS is unable to add any more information. Topical
mercuric preparations banned in 8 countries and restricted in eight (HAI,
2008).