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Pomalyst and Pregnancy

As a pregnancy Category X medication, Pomalyst (pomalidomide) should not be used during pregnancy. Studies have shown that the potential risks of using this drug while pregnant clearly outweigh the benefits. Even men who are undergoing treatment with this drug should take precautions to avoid getting a woman pregnant.

Can Pregnant Women Take Pomalyst?

Pomalyst® (pomalidomide) can cause serious birth defects or death in a developing baby, and should not be used by women who are pregnant or may become pregnant. Pomalyst is considered a pregnancy Category X medication.

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. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the drug. With this category, the potential risks clearly outweigh the potential benefits.
Pomalyst is a thalidomide analog, which means it is similar to the medication thalidomide (Thalomid®). The birth defects associated with thalidomide are well known and include:
  • Short or absent arms and legs
  • Ear and eye abnormalities
  • Problems with bone development
  • Heart defects.
Pomalyst has not been studied in pregnant women. Doing so would be unethical since it is similar to thalidomide, a medication known to cause birth defects. When Pomalyst was given to pregnant rats and rabbits, it caused a variety of birth defects, including defects of the bladder, bones, limbs (arms and legs), and heart.
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