Introduction - Uppsala Monitoring Centre

and Venezuela and worldwide in 1985. Restricted to rectal use. HAI: banned
in 20 countries.
Availability: Veripaque still used in Ireland and UK in an enema (BNF, 1999).
Drug Lifespan: 15 years
Delay in recognition: 15 years
Delay in regulatory action: less than one year
Time span of withdrawals: 15 years
Comment: it is curious that that the first country to withdraw the drug was Cuba,
which rarely leads the field in this area.
1956 October 1st Thalidomide (Contergan (WG), Distaval (UK), Kevadon (Canada),
Softenon (Portugal) introduced (see 1956 AD)
First synthesized in 1954 by Chemie Gruenthal GmbH in West Germany.
Use: a 1956 leaflet said that that the indications were: irritability, weak
concentration, stage fright, ejaculation praecox, menstrual tension,
postmenopausal symptoms, fear of examination, functional disorders of the
stomach and gall bladder, febrile infectious diseases, mild depression,
anxiety, hyperthyroidism and tuberculosis (McCredie, 2008). A veritable
universal panacea.
ADR: phocomelia (First case December 25 th 1956; Lenz’s disclosure on
November 18 th 1961; McBride’s BMJ Letter on December 16th 1961) and
peripheral neuritis (First case October 3 rd 1959; Florence letter on December
31 st 1960; over 300 cases February 15 th 1961). Other ADRs: neutropenia,
pulmonary embolism, oedema, hypercalcaemia, confusion, nausea, Stevens-
Johnson syndrome, toxic epidermal necrosis(TEN), constipation, dizziness,
hangover, loss of memory, decrease in blood pressure, purpura and tremor.
Withdrawn: in Germany on November 28 th 1961, Australia, Austria, Cyprus,
Denmark, Finland, Guinea, Iraq, Jordan, Lebanon, Mozambique, Norway,
Portugal, Saudi Arabia, Sudan, Switzerland, Syria, and the UK in 1961;
Belgium, Brazil, Ireland, Canada (March), Italy (September), Argentina
(March), Spain, Sweden (14 th March), Taiwan and India in 1962, in Japan in
1963 (January). Not approved in France, Hungary, Yugoslavia, Venezuela
and the USA. Relaunched for treatment of leprosy and multiple myeloma. Due
to a delay in obtaining the information and taking effective measures in Japan,
an order to stop its distribution and for total recall of the products was not
issued until 1962, 9 months after the sale in West Germany had been stopped
(Suzuki, 1980). Italy withdrew the drug ten months after it had been withdrawn
in West Germany. HAI: banned in 5 countries and restricted in seven.
Availability: for specific indications only: erythema nodosum leprosum, aphthous
stomatitis, Bechet’s disease, lupus erythematosis, prurigo nodularis. Also
used in, but nor so effectively: actinoprurigo, Langerhans cell histiocytosis,