Is one epidemic to cause another?
Victims of AIDS may benefit from Thalidomide - and the exposed fetus?
Thalidomide (PDF File)
OTIS, July 2003
"... 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 ..."
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
1961, Lenz suggested that these deformities resulted from the mothers having
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
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
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
Femur is quite often the only long bone to be affected
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
Dermoid cysts on the surface of the eye are less common and
tend to occur in association with anotia or microtia
squint is common in association with any of the eye abnormalities described
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
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.
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 ... "
FDA page expanded by links to other information sources
FDA, January 6, 2006
H Burkholz, Public Affairs Staff, FDA, 1997
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.
in the News
Thalidomide Victims Association of Canada, 2006
AIDS Treatment Data Network, August 15, 2006
"... For people that cannot enter (clinical trial), Celgene has started
an expanded access program ..."
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
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
I.B.I.S. Birth Defects, July 2, 2000
Fact sheet for health professionals.
Special Thalidomide Issue of Geno-Terato-Epi-Tome
I.B.I.S. Birth Defects, February 15, 2002
Thalidomide and Health
I.B.I.S. Birth Defects, February 5, 2002
Fact sheet for prospective parents.
Last Updated: 2007/08/20