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Extina and Pregnancy

When the active ingredient in Extina (ketoconazole foam) was given orally to pregnant animals, it appeared to increase the risk for birth defects. Because of these risks, Extina is classified as a pregnancy Category C medication. However, because Extina is applied on the skin rather than swallowed, only a small amount of the drug is expected to reach the bloodstream.

Can Pregnant Women Use Extina?

Extina® (ketoconazole foam) is a prescription skin medication used to treat seborrhea. Based on information currently available, it is unclear whether the drug is safe for use during pregnancy. As with most medications, it should be used only if necessary, at the lowest effective dose, and for the shortest possible time as necessary during pregnancy.
 

What Is Pregnancy Category C?

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. Extina is classified as a pregnancy Category C medication.
 
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Animal studies have shown that ketoconazole (the active ingredient), when taken by mouth, may cause birth defects. However, very little ketoconazole is absorbed through the skin into the bloodstream with normal Extina use. However, because Extina has not been studied in any pregnant women, the possibility of problems cannot be completely ruled out.
 

Final Thoughts

If you are pregnant or thinking about becoming pregnant while using Extina, let your healthcare provider know. He or she will consider the benefits and risks before making a recommendation in your particular situation.
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