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Past, Present & Future
By Monica Duarte
1. History of Thalidomide: Harmful effects that
lead to the ban in 1962.
2. Structure of Thalidomide: Chemical make up and
chirality/enantiomer issue that led to problems.
3. Thalidomide makes a comeback in 1998 with the
approval by the FDA: current uses of the drug.
4. Celgene Corporation- Manufactures of new
Thalidomide family, Thalomid TM
5. S.T.E.P.S Program developed by Celgene to
regulate Thalomid TM distribution
6. Future of Thalidomide
(Photo Courtesy of:
1953- Originally synthesized by Ciba, a Swiss
pharmaceutical company
1954-Chemie Grurnrnthal, German
Pharmaceutical company, assumed developed
of Thalidomide.
1957-Mass production & distribution
throughout Europe by Chemie.
Promoted by maker as being nontoxic, with no side
effects and completely safe for pregnant women.
1960-Distributed throughout Australia, Asia,
Africa, Canada (total of 43 nations)
1957-1962 given to pregnant women
primarily as a sedative, a sleeping pill, aid
with morning sickness.
US FDA did not approve Thalidomide for use
in America.
Dr. Frances Kelsey
(Photo courteous: )
(Courtesy of:
(Photo Courtesy of:
History (Continued)
Approximately 10,000 “Thalidomide
Babies” were born throughout 43 countries
 A number of infants were born with a
severe deformity of the limbs
 The drug restricted the growth of rapidly
growing blood vessels in developing limbs
and organs
(Courtesy of:
(Photo courtesy of:
Worldwide Ban 1962
(Courtesy of:
Problem with Thalidomide
Chirality &
Enantiomer issues
(Courtesy of http//
Problem with Thalidomide
R-complex (desired effect)
L-complex (created fetal abnormalities)
Spontaneous interconversion
lead to a racemic mixture (50/50).
The Comeback of Thalidomide
as ThalomidTM
FDA approves use of Thalidomide
to treat Erythema Nodosum Leprosum
(ENL) July 1998
How Thalidomide Works:
1. Reduces production of TNF-α (Tumor Necrosis Factor -α )
Thalidomide works as immunomodulatory
2. Inhibits growth of new blood vessels
3. Works as anti-inflammatory
Mechanism of action not exactly understood
Current uses under “Orphan”
drug basis
wasting syndrome
Aphthous ulcers
Behcets’s sydrome
Crohn’s disease
Kaposi’s saracomaAIDS related cancer
Celgene Corporation
Manufactures of new family, derivative of
Thalidomide called Thalomid.
 Same chirality
 Still racemic mixture
 Same side effects
 Same chemical structure
(Courtesy of
S.T.E.P.S Program
System for Thalidomide Education and
Prescribing Safety
A program created by Celgene in
conjunction with FDA
S.T.E.P.S Guidelines
Patient Registration
Physician education
Females: monthly
pregnancy testing and
birth control measures
Patient consent form
Limits authorized
prescribers and
Patient education
Patient counseling
Discovery and development of
new classes by Celgene Co.
IMiDs-immunomodulatory drugs
SelCIDs-Selective Cykotine Inhibitory Drugs
Both have been found to be significantly more
potent in vitro inhibitors of TNF- α than Thalomid
Currently being studied for
future uses:
Rheumatoid arthritis
Multiple Sclerosis
Multiple Myeloma
(Courtesy of:
Agarwal, M.B. Thalidomide: An old wine in new bottle. JAPI, vol.51, p.597-604, 2003
Author unknown. Thalidomide Pros and Cons. American Journal of Nursing, vol.98(4),p.63,1998.
Dally, A. Thalidomide: was the tragedy preventable? Lancet, vol. 351, p.1197-1199, 1998.
Hamuryudan, V. Thalidomide in the treatment of the mucocutaneous lesions of the Behcet syndrome: a
randomized, double-bind, placebo-controlled trial. The Journal of the American Medical Association, vol.
279(18), p. 1422G(1),1998.
Jacobson, J., Greenspan, J., & Spritzler, J. Thalidomide for the treatment of oral aphthous ulcers in patients
with human immunodeficiency virus infection. The New England Journal of Medicine, vol.336(21), p.1487(7).
Kling, Jim. Redeeming Thalidomide. Modern Drug Discovery, vol.3(5), p.35-39,2000
Marwick, C. Thalidomide back-under strict control. The Journal of the American Medical Association,
Patil, C.R. & Bhise, S.B. Indian Jornal of Pharmacology, vol. 35, p. 204-212, 2003.
Stambe, C. & Wicks, I. TNFa and response of treatment-resistant adult-onset Still disease to thalidomide.
Lancet, vol.352(28), p.544.
Photos from the web
(Photo courteous:
(Photo courteous: )