Thalidomide (PDF File)
OTIS, July 2003
[Support Groups]
"... The information below will help you determine if your prenetal exposure to thalidomide will increase the fetal risk above the background risk ... with every pregnancy, any woman has a 3 to 5 percent chance to have a baby with a birth defect ... what is thalidomide ... will taking thalidomide have an effect on a baby's behavior and development ...Thalidomide is a sedative agent that also changes the body's immune response and reduces the ability of the body to grow new blood vessels. Thalidomide was one of the first drugs recognized to cause birth defects in humans. Although thalidomide was never released in the United States, it is now being studied for treatment of many different, serious medical problems ... there are no studies on pregnancy outcome in women who only used thalidomide prior to conception ... there are no reports linking thalidomide use and infertility ... when a pregnant woman takes thalidomide 34-50 days (4.5 to 7 weeks) after the beginning of her last menstrual period, there is a risk of approx. 20% or greater to have a baby with problems such as extremely short or missing arms and legs, missing ears (both outside and inside), and deafness. There is also a risk of other problems such as heart defects, missing or small eyes, paralysis of the face, kidney abnormalities, and mental retardation. The risk for fetal damage if the drug is taken after the first trimester is unknown ..."

Recognition of Thalidomide Defects
R. W. Smithells, et al, Journal of Medical Genetics 1999, 229:716, Thalidomide Victims Association of Canada
[for Professionals Mainly]
... Thalidomide (alpha-phthalimido-glutarimide) was developed by the German firm Chemie Grunenthal … German pediatricians and geneticists began to see children with gross limb malformations of a most unusual pattern. When two cases were shown at a pediatric meeting in Kassel by Kosenowand Pfeiffer in October 1960, few people present had ever seen similar limb defects. Widedmann in 1961 described 13 affected infants … In November 1961, Lenz suggested that these deformities resulted from the mothers having taken thalidomide … The extent of the symmetry varies according to the nature of the defect, both in the closeness and the match between left and right, and in the proportion of cases which are appreciably asymmetrical. The significance of symmetry will be discussed in relation to each defect group … Thumbs and thenar mussels … X-rays of the thumbs are often extremely informative. Human embryo … sensitive to thalidomide from approximately 34 to 50 days after … The thumbs appear to be the first part of the skeleton to be affected, and the last … Complete absence of the thumbs is far more common than thumb deformity … Thumbs affected by thalidomide quite often contain three phalanges … Reduction deformities of the redius tend to start at the distal end and extend towards the elbow … Humerus also tends to be affected from the distal to the proximal end … The scapula and clavicle are not subject to deformity as the arm bones are … Bilateral symmetry is more marked with defects of the upper limbs than it is with lower limb … The majority of people with thalidomide defects of the upper limbs have normal lower limbs … Lower limb defects is more variable than in the upper limbs … Femur is quite often the only long bone to be affected … The second most common group of defects, grouped because of their tendency to occur in a variety of combinations and permutations, involves developmental abnormalities of the ear and eye … Ear defects tend to be bilateral and fairly symmetrical. In the most extreme cases, the pinna is completely absent (anotia) and the external auditory meatus is a bind pit … Weakness of the facial muscles (usually affecting the whole face, but occasionally only part) is much more often unilateral than bilateral, and is almost invariably associated with anotia or microtia on the same side … Hips may be dislocated or unstable at birth … Dermoid cysts on the surface of the eye are less common and tend to occur in association with anotia or microtia … Squint … Not surprisingly, squint is common in association with any of the eye abnormalities described above … Cleft lip and palate … These occur among persons affected by thalidomide more often than in the general population. The deformities appear not to differ from other facial clefts ...

The History of Thalidomide
Dr. Widukind Lenz, Thalidomide Victims Association of Canada
Extract from lecture at 1992 UNITH Congress.

Special Thalidomide Publication
W.Wertelecki, I.B.I.S. Birth Defects
The "GENO-TERATO-EPI-TOME" - Genetics, Teratology, Epidemiology in Brief

Thalidomide Susceptibility
Victor A. McKusick, OMIM, Johns Hopkins University, July 7, 1994
" ... Genetic differences in susceptibility to the teratogenic effects of thalidomide are suspected but unproved ... "

Modern Unawareness - March of Dimes
I.B.I.S. Birth Defects
Many prospective parents do not recognize the word "Thalidomide" ...

Thalidomide Victims Association of Canada (TVAC)
Thalidomide is a drug that was introduced on to the market on October 1, 1957. The Thalidomide Victims Association of Canada (TVAC) is an organization representing approximately 125 Canadians born disabled as a consequence of the drug Thalidomide.

Thalidomide: Potential Benefits and Risks
National Library of Medicine Bibliography, August 28, 1997

Food and Drug Administration or FDA: Warning to those who may become pregnant
FDA, July 7, 2005
" ... Thalidomide ... not approved for general sale ... however, the FDA allows it to be used in studies ... of certain severe or life threatening diseases ... "

A similar FDA page expanded by links to other information sources
FDA, January 6, 2006

Another FDA page
H Burkholz, Public Affairs Staff, FDA, 1997

Unprecedented Restrictions on Distribution of Thalidomide
FDA, July 16, 1998
STEPS or S-ystem for T-halidomide E-ducation and P-rescribing S-afety. Will it work in the developing world?
STEPS - More details.

Thalidomide in the News
Thalidomide Victims Association of Canada, 2006

Thalidomide
AIDS Treatment Data Network, August 15, 2006
"... For people that cannot enter (clinical trial), Celgene has started an expanded access program ..."

Thalidomide Embryopathy
Marina Solari, M.D. theFetus.net
… In utero exposure to thalidomide, characterized by fetal anomalies (limb, facial, kidney, cardiac, spinal, anal, and CNS), growth and mental function (autism) abnormalities … Exposure to thalidomide in the first trimester carries a 10-50% risk of embryopathy … Susceptible period is considered 34 to 50 days after the beginning of the mother's last menstrual period … Diagnosed by ultrasound examination at 17 weeks gestation. Limb abnormalities are characterized by phocomelia, amelia, clubfeet and supernumerary fingers. Facial abnormalities include microtia, facial palsy, orofacial cleft and microphtalmia. Cardiac malformations range from ventricular or atrial septal defect to conotruncal defects. Poor fetal growth, urogenital, gestrointestinal and spinal defects may occur ...

Thalidomide Embryopathy Syndrome
I.B.I.S. Birth Defects, July 2, 2000
[Ukrainian]
Fact sheet for health professionals.

Special Thalidomide Issue of Geno-Terato-Epi-Tome
I.B.I.S. Birth Defects, February 15, 2002
[Ukrainian]

Thalidomide and Health
I.B.I.S. Birth Defects, February 5, 2002
[Ukrainian]
Fact sheet for prospective parents.

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Last Updated: 2007/08/20

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