Do not take this drug if there is any possibility that you are, or may become, pregnant. Just one dose can cause severe birth defects. Thalidomide (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 treatment. The 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 PATIENTS:

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 Thalidomide:

• 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 methods.

If you cannot avoid the chance of pregnancy, you must not take thalidomide.

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 pregnant.

You must also refrain from any other activities that could result in pregnancy (for example, fertilization methods).

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 abstinence. You stop using birth control. You think that you are pregnant. You become pregnant.

If you become pregnant, you must immediately stop taking thalidomide. You should contact your doctor to discuss whether or not to continue your pregnancy.

WARNING FOR MALE PATIENTS:

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 PATIENTS:

Thalidomide has been prescribed only for you.

Do not share it or give it to others. It can be extremely harmful if used by others.

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 you.

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 thalidomide.

Check with your doctor before taking any other prescription or over-the-counter medication.

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 doctor.

Any side effect should be reported to your doctor. The following list contains additional side effects that may occur while you are taking thalidomide:

mood changes
dry mouth
headache
nausea
constipation
increased appetite
puffiness of the face and limbs (edema)
dry skin
itching
irregular menstrual period
low white blood cell count
thyroid problems
blood sugar that is too high or low
slow heart beat

You must return any unused thalidomide to your doctor.

Health and Human Services - Public Health Service - Food and Drug Administration
DHHS Publication No.(FDA) 96-3222

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September 11, 1997
http://www.fda.gov/cder/news/thalidomide.htm