Thalidomide is a drug that was marketed outside of the United States in the late 1950’s and early 1960’s. It was used as a sleeping pill, and to treat morning sickness during pregnancy. However, its use by pregnant women resulted in the birth of thousands of deformed babies.

Depending on your medical condition, your doctor may prescribe Thalomid (thalidomide) at a dose between 100 mg and 300 mg to be taken once a day with water. It is recommended that the dose be taken at bedtime at least 1 hour after the evening meal.

The most serious side effect known with Thalomid (thalidomide) is its risk of severe birth defects or death to an unborn baby, even after taking one dose. Therefore, if you are pregnant or trying to get pregnant, you must not take Thalomid (thalidomide). Nerve damage that can be severe and permanent. If you notice any numbness, tingling, or pain or a burning sensation in your hands and feet, stop taking Thalomid (thalidomide) and call your health care provider.

Thalomid (thalidomide) can interact with certain other medications. Therefore, it is important to review all medications that you are taking with your health care provider, including those that you take without a prescription. Thalidomide has been reported to increase the sedative effect of barbiturates, alcohol, chlorpromazine, and reserpine. Medications that are known to cause numbness, tingling or nerve pain should be used cautiously with Thalomid (thalidomide).

Thalomid (thalidomide) will be available as a 50mg oral capsule. Thalomid (thalidomide) will be limited to a maximum of a 1-month supply.

NEVER share Thalomid (thalidomide) with anyone. Return any unused Thalomid (thalidomide) to your pharmacy. Your pharmacy will accept all unused Thalomid (thalidomide) as part of the controlled distribution system.

Thalomid (thalidomide) is approved to treat the painful, disfiguring skin sores associated with leprosy, and to prevent and control the return of these skin sores.

Adequate and well-controlled studies are needed to determine if thalidomide is effective in treating other diseases.

NO. You must not breast-feed a baby while taking Thalomid (thalidomide) because of possible side effects to the infant.

Thalomid (thalidomide) will be available by prescription only from physicians and pharmacies registered in the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) program.

The FDA has no input into or legal control over whether an insurance company does or does not cover the cost of drugs. Please call your insurance company if you have questions abut whether your particular insurance provider will cover the cost of Thalomid (thalidomide).

The FDA has set up additional safeguards for the use of Thalomid (thalidomide) by men and women. The Agency has worked closely with the manufacturer, the Canadian Thalidomide Victims Association, and others to develop a program to ensure the safe and effective use of Thalomid (thalidomide). If there is even ONE fetal exposure to Thalomid (thalidomide), the Agency will re-evaluate the entire distribution system and take the necessary steps to ensure that all deficiencies are corrected.

NO. A pregnant woman or any woman thinking about becoming pregnant must not take Thalomid (thalidomide), because it is known to cause severe birth defects or death to an unborn baby, even after taking just one dose. When a woman of child-bearing age has no other appropriate treatment choice and must take Thalomid (thalidomide), there are many precautions that must be taken to avoid pregnancy.

Because they are not cytotoxic in the patient ? they use other methods of killing cells (maybe including direct cytotoxicity) and TRAC currently only measures cytotoxicity. Drugs that kill by ADCC (antibody-dependent cell-mediated cytotoxicity) or compliment fixation, for example, may not 'work' in a cytotoxicity (cell death) test in the laboratory.

IMF PRESENTS THE KYLE LIFETIME ACHIEVEMENT AWARD TO MARIO BOCCADORO, MD, OF THE UNIVERSITY OF TORINO, ITALY