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“Quality,
Reliability and Consistency”
Thalidomide
– The Facts…
Thalidomide
is a non-barbiturate hypnotic drug, and was first discovered in
Germany
in 1954. By 1957, it was actively marketed in
Germany
and many other countries throughout the World to treat,
surprisingly minor ailments such as colds, coughs and flu.
By
the time the drug was withdrawn in
Germany
on
27th
November 1961
,
Thalidomide, was marketed under fifty-one names, in eleven
European, seven African, seventeen Asian and eleven countries
throughout the
Americas
.
The
drug was first marketed in
Britain
in April 1958, by Distillers Company (Biochemicals) Limited
under the names Thalidomide, Distaval, Tensival, Asmaval, Valgis
and Valgraine.
For
two years, it was available over the counter as well as by
prescription.
Thalidomide
was promoted widely as a 'Wonder Drug', and just prior to its
withdrawal in the
UK
,
Distillers, were actively marketing Thalidomide even with
literature stressing how safe the drug was, "without any
risk to mother or child."
If
Thalidomide was taken throughout the sensitive period (counting
from 1st day of conception) between day 35 and day
49, the consequences were generally severe defects of ears, arms
and legs and of internal malformations, which often led to early
death.
There
were 12,000 Thalidomide impaired babies born world wide, and
about another 40 per cent of that number died before their first
birthday.
In
1993, Yorkshire Television through its First Tuesday documentary
series found in
Brazil
alone twenty-one new cases of Thalidomide, aged from four to
twenty-three, in such diverse locations as
Rio
de Janeiro
and the heart of the Amazon Jungle.
On
16th
July 1998
,
the Federal Drugs Administration in the
United
States
approved the marketing of THALOMID®
for the acute treatment of the cutaneous manifestations of moderate to
severe erythema nodosum leprosum (ENL) and maintenance therapy for
prevention and suppression of the cutaneous manifestations of
ENL recurrences.
The
Thalidomide Victims association of Canada (TVAC) was consulted
in the process of licensing, and was given unprecedented access
to all materials associated with the return of Thalidomide.
Celgene
is also working with THALOMID®
(thalidomide) to develop new families of pharmaceuticals called
Immunomondulatory Drugs, or IMiDs™,
and Selective Cytokine Inhibitory Drugs, or SelCIDs™;
including vigorously pursuing the development of new
applications and new drugs derived from THALOMID®
(thalidomide).
Celgene
and TVAC developed S.T.E.P.S.™
‘System
for Thalidomide Education and Prescribing Safety’
- a comprehensive information package for both prescribers and
patients.
2008
Celgene was granted a licence to distribute Thalidomide for
Multiple Myeloma.
More
information on the current status of Thalidomide and its
manufacturers can be found in ‘Four
Fingers and Thirteen Toes’
(by
Rosaleen
Moriarty-Simmonds
,
ISBN 0954888324)
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