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Thalomid and Pregnancy

Because Thalomid (thalidomide) has been proven to cause severe birth defects and fetal death, it is important that a woman not take this drug while pregnant. This medicine is classified as a pregnancy Category X drug, meaning the risks clearly outweigh the benefits. To ensure a safe treatment, women of childbearing potential must follow strict guidelines to ensure they do not become pregnant.

Can Pregnant Women Take Thalomid?

Thalomid® (thalidomide) should not be taken by pregnant women or women who may become pregnant. This is because the medication can cause birth defects or even death in an unborn child.
 

What Is Pregnancy Category X?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Thalomid has been given a pregnancy Category X classification.
 
Pregnancy Category X is given to medicines that show fetal problems in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
 
When used in pregnant women, Thalomid is known to cause severe and life-threatening birth defects. It was one of the first medications shown to be dangerous for use during pregnancy, and may have caused more severe birth defects than any other medicine. The medication is so dangerous during pregnancy that even one dose can cause problems in an unborn baby.
 
The most common birth defect reported from Thalomid use is abnormal development of the arms and legs. The arms and legs may be shortened or, in severe cases, missing. A variety of other defects have also been reported, such as malformations of the head and face, eyes, ears, tongue, teeth, lungs, heart, and digestive tract. The medication has been reported to cause death at or shortly after birth in about 40 percent of infants whose mothers took the medicine while pregnant.
 
Because of the serious risks associated with using Thalomid during pregnancy, the medication should not be taken by a woman who is pregnant or may become pregnant. Women of childbearing potential who take the medicine must agree to use two forms of birth control for at least four weeks before starting Thalomid, while taking the medication, and for at least two weeks after treatment ends. Any woman who has not had a hysterectomy or who has not been in menopause for at least 24 months is considered to be a woman of childbearing potential.
 
One of the forms of birth control used during Thalomid treatment must be considered highly effective, such as birth control pills, tubal ligation, or an intrauterine device (IUD). Talk to your healthcare provider about the most effective birth control options for your individual situation.
 
If you are a woman of childbearing potential, your healthcare provider will make sure you are not pregnant by giving you a pregnancy test within 24 hours of starting Thalomid. Your healthcare provider will not prescribe the medicine until he or she has a written report that you are not pregnant. Once treatment beings, you must have a pregnancy test every week for the first month. Thereafter, pregnancy tests will be given every two weeks in women with irregular menstrual cycles and every month in women with regular menstrual cycles.
 
In addition, Thalomid is found in semen. Therefore, men taking the medication, including men who have had a vasectomy, must agree to use a condom during sex with a woman of childbearing potential. Men taking Thalomid should also not donate sperm during treatment and for at least four weeks after treatment ends, as the sperm could cause birth defects.
 
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