Derma-Smoothe and Pregnancy

It may not be safe for women to use Derma-Smoothe (fluocinolone oil) during pregnancy, based on the results of animal studies. Corticosteroid medications, such as Derma-Smoothe, have been shown to increase the risk for birth defects, impair fetal growth, and decrease survival when used during animal studies. Also, Derma-Smoothe is a highly potent steroid, and there may be safer options for women who are expecting.

Can Pregnant Women Use Derma-Smoothe?

Derma-Smoothe/FS® (fluocinolone oil) is a prescription skin medication used to treat certain types of chronic skin conditions. It belongs to a group of medicines known as corticosteroids. Based on the results of animal studies, this medication may not be safe for use during pregnancy, although the full risks are not currently known.
 

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. Derma-Smoothe is classified as a pregnancy Category C medication.
 
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause fetal harm in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
In animal studies, corticosteroid medications have been shown to increase the risk for birth defects (such as cleft palate), impair fetal growth, and decrease survival. Derma-Smoothe has not been adequately studied in pregnant women.
 
It is important to note, however, 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 the unborn child.
 
It is also important to note that Derma-Smoothe is applied directly to the skin, not taken by mouth. When used for a short period of time, and on limited areas of the body, the medication is not likely to be absorbed through the skin, and is therefore not likely to cause problems. However, using the medicine over large areas of the body and covering the exposed skin with a dressing or bandage will increase the amount absorbed.
 
Derma-Smoothe is a potent corticosteroid. In general, if a pregnant woman requires long-term use of a corticosteroid, a less potent one should be used if at all possible, as less potent corticosteroids are less likely to cause steroid side effects.
 
Pregnancy and Pain

Derma-Smoothe Oil Information

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