Based on animal studies, the FDA has classified Differin (adapalene) as a pregnancy Category C medication, meaning it may not be safe for women who are expecting. However, animals do not always respond to medicines in the same way that humans do, and this drug may still be prescribed if the benefits outweigh the risks.
Can Pregnant Women Use Differin?
Differin® (adapalene) is a prescription skin medication used for the treatment of 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 largely 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.
When given orally to pregnant rats, Differin (at doses equivalent to 25 times the exposure seen with human use on the skin) did not cause any problems. However, extremely high doses (equivalent to 123 to 246 times the exposure seen with human use on the skin) caused a variety of different birth defects in rats and rabbits.
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 pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
There have been only a few reported cases of Differin use during pregnancy; these cases did not suggest any clear risk from the drug (although there are far too few cases to draw any conclusions).
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