Introduction - Uppsala Monitoring Centre

Delay in recognition: ≤ one year
Delay in regulatory action: 4 years
Time span of withdrawals: 21 years
Comment: congressional hearings conducted as early as 1964 exposed FDA’s
lack of knowledge of important information linking the use of Orabilex
(bunamiodyl sodium),
(www.thefreelibrary.com/Turning+the+tables+on+drug+companies%3B+expo
sing+deficiencies+in+FDA...-a014940642).
1958 Buformin (Silubin, Sindiatil)
Use: an anti-diabetic drug (a biguanide)
ADR: lactic acidosis. First mention of lactic acidosis was in 1978 (Depperman et
al., 1978).
Withdrawn: in 1978 in Germany, Austria and Italy (restricted dosage), and in
Belgium and Ireland in 1979, because of lactic acidosis.
SED 1980: the relative risk calculated from the Swiss data (1972–1977) was
0.07 for metformin, 0.31 for buformin and 0.40 for phenformin. Phenformin
and buformin are more lipophilic that metformin.
Availability: still available in some countries–Czechoslovakia, Hungary, Spain
and Japan.
Drug Lifespan: 20 years
Delay in recognition: less than one year
Delay in regulatory action: none
Time span of withdrawals: one year
Comment: an example of a class ADR with differing incidence of the ADR in one
class member.
1958 Cupric bis-quinolone sulfate/triethylamine (Cuproxane)
Use: Vidal 1964 – anti-inflammatory, analgesic and anti-infective used for
rheumatism and furunculosis resistant to antibiotics contained copper 9% and
triméthylamine 18%.
ADR: neuromuscular problems, metallic taste, sore throat, dysphagia, epigastric
pain, vomiting, diarrhoea, limb, chest and abdominal cramps, and circulatory
collapse. No mention in SED.
Withdrawn: in France in 1978
Availability: none
Drug Lifespan: 20 years
Delay in recognition: unable to find any relevant papers. The AFSSAPS is
unable to add any more information.
Delay in regulatory action: ?
Comment: probably only licensed in France.