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Epiduo and Pregnancy

The FDA has given a pregnancy Category C rating to Epiduo (adapalene/benzoyl peroxide). This means that the acne drug may not be safe for use in women who are expecting. In studies of pregnant rats and rabbits, giving large oral doses of one of the active ingredients in this drug caused birth defects, such as neural tube defects, cleft palate, and bone problems.

Can I Use Epiduo When Pregnant?

Epiduo® (adapalene/benzoyl peroxide) is a prescription skin medication used to treat acne. Based on information from animal studies, this drug does not appear to be particularly dangerous during pregnancy, although the possible risks to humans are mostly unknown at this time.

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies.
Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Epiduo has not been studied in pregnant animals or pregnant women. However, adapalene, one of the active ingredients in Epiduo, has been studied in pregnant animals. When given orally to pregnant rats, adapalene did not cause any problems. However, extremely high doses of adapalene given orally caused a variety of different birth defects in rats and rabbits, including neural tube defects, cleft palate, and bone problems.
When applied to the skin of pregnant rats and rabbits, large amounts of adapalene did not cause harm to the fetus.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
With normal use, very little Epiduo is expected to be absorbed through the skin. Therefore, very little would be absorbed into the bloodstream and passed on to the developing fetus during pregnancy. However, the current information about Epiduo use during pregnancy is limited.
Pregnancy and Pain

Epiduo Medication Information

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