Do not take this drug
if there is any possibility that you are, or may become,
pregnant. Just one dose can cause severe birth
(tha-lid-o-mide) was first marketed in Europe in the late
1950's. It was used as a sleeping pill and to treat morning
sickness during pregnancy. At that time no one knew thalidomide
caused birth defects. Thalidomide is not approved for general sale
in the United States. However, the Food and Drug Administration
allows it to be used in studies (such as this one).
These are studies of certain
severe or life threatening diseases where there may be no other
purpose of this study is to attempt to treat your condition and
to gather information about the safety and the potential
benefit of thalidomide. While you are taking thalidomide, you will be
told by your doctor of any new information that might cause you
to change your mind about taking thalidomide.
WARNING FOR FEMALE
Tragically, when thalidomide
was used by pregnant women, it resulted in the birth of
thousands of deformed babies. In 1961 scientists discovered
that the medication stunted the growth of fetal arms and legs.
In fact, taking only one dose of thalidomide early in pregnancy
can severely affect the growth of fetal limbs (arms, legs,
hands, feet). It also puts the fetus at risk of other injuries,
including eye and ear defects and severe internal defects of
the heart, genitals, kidneys, digestive tract (including lips
and mouth), and nervous system.
Female Patients Who Take
- You must not take
thalidomide if you are pregnant.
- You must have a blood or
urine pregnancy test before starting treatment. Results of
this test must show that you are not pregnant. The tests
should be done and interpreted by your doctor. These tests
must be repeated every month while you are taking
thalidomide and four weeks after your last dose of
thalidomide. More frequent pregnancy tests may be needed if
you have an irregular menstrual period, vaginal bleeding,
or if you miss a period.
- You must abstain from
sexual intercourse or use two highly effective birth
control methods at the same time for at least one month
before receiving thalidomide. You must continue these
methods until one month after the last dose of thalidomide.
Ask your doctor about birth control
If you cannot avoid the
chance of pregnancy, you must not take
Remember, no method of birth
control is completely reliable except for having no sexual
intercourse at all (abstinence).
If you do not practice
abstinence or you have not had a hysterectomy, you must use
birth control even if you believe you cannot become
You must also refrain from any
other activities that could result in pregnancy (for example,
You must not take thalidomide
if you are nursing a baby.
You must immediately stop
taking thalidomide and inform your doctor if:
- You have a late or an
irregular menstrual period.
- You stop practicing
- You stop using birth
- You think that you are
- You become
If you become pregnant, you
must immediately stop taking thalidomide. You should
contact your doctor to discuss whether or not to continue your
WARNING FOR MALE
You must abstain from sexual
intercourse or use a condom during intercourse while, and for
one month after, taking thalidomide. It is not known if
thalidomide is present in male ejaculate (semen).
GENERAL GUIDELINES FOR ALL
Thalidomide has been
prescribed only for you.
Do not share it or give it
to others. It can be extremely harmful if used by
Be sure to take your
medication as prescribed by your doctor. If there is anything
you do not understand, ask your doctor to explain it to
Thalidomide often causes
drowsiness. You should avoid drinking alcohol or taking other
medications that also make you sleepy. Thalidomide can reduce
your ability to drive or operate machinery. It can also reduce
your alertness and ability to think clearly.
Thalidomide might cause damage
to your nerves. It is not known whether this nerve damage is
reversible after the drug is stopped. Symptoms of nerve damage
include burning, numbness, or tingling of your arms, hands,
legs, or feet. Call your doctor if you have any questions, or
experience any of these or other troubling symptoms.
Your doctor may do special
laboratory tests to check for nerve damage. If nerve damage is
found, you and your doctor can decide whether the benefit that
you might be receiving from thalidomide outweighs the risk of
possible permanent damage to your nerves if you continue taking
Check with your doctor before
taking any other prescription or over-the-counter
If you develop a skin rash
with or without a fever, fast heart beat, or low blood
pressure, immediately stop taking thalidomide and contact your
Any side effect should be
reported to your doctor. The following list contains additional
side effects that may occur while you are taking
puffiness of the face and
low white blood cell
blood sugar that is too high
You must return any unused
thalidomide to your doctor.
*Food and Drug
The National Cancer
The National Eye Institute
The National Heart, Lung, and Blood
National Institute on Aging
National Institute of Allergy and
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
National Institute of Diabetes and
Digestive and Kidney Diseases
National Institute on Drug
National Institute of Mental
National Institute of Neurological
Disorders and Stroke