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Elidel and Pregnancy

Although no research has been done on women using Elidel (pimecrolimus) during pregnancy, animal research has shown that miscarriages could occur if high doses of this drug are taken by mouth. When used topically on the skin, it did not appear to increase the risk for birth defects. Due to the unknown risks, pregnant women should talk to their doctor before using this medicine.

Can Pregnant Women Use Elidel?

Elidel® (pimecrolimus) is a prescription medication used for the short-term treatment of mild-to-moderate atopic dermatitis (eczema). Based on animal studies, this medication may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Elidel is classified as a pregnancy Category C drug. 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 used during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused 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.
Elidel has not been studied in pregnant women. In animal studies, the medication did not cause any problems when it was applied topically on the skin of pregnant rats or rabbits. When given to the pregnant rats and rabbits by mouth, Elidel increased the risk for miscarriages at high doses, but not at low doses. The drug did not appear to increase the risk for birth defects in the rats and rabbits at any dose.
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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
It is important to keep in mind that Elidel is a topical medicine, which means it is applied directly on the skin. Only a small amount of the drug is expected to be absorbed through the skin into the bloodstream after normal use. However, certain people could absorb more medicine than expected, such as those with certain skin conditions or people who use the medicine on large areas of skin.
Pregnancy and Pain

Elidel Medication Information

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