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Asclera and Pregnancy
Animal studies on the effects of Asclera (polidocanol) use during pregnancy showed problems -- namely low fetal weight and decreased chance of survival. This was in rabbits, however; when given to rats, Asclera didn't appear to cause any problems. As a result, the FDA considers this product to be a pregnancy Category C drug. It could be given to a pregnant woman, but is not typically medically necessary.
from eMedTV.comCan Pregnant Women Use Asclera?
Asclera™ (polidocanol) is a prescription medication approved for treating spider veins and reticular veins (which are similar to spider veins, although larger and deeper under the skin). The medication is injected directly into the affected veins.
It is not clear if this drug is safe for use during pregnancy, as the full risks are not currently known. It has been shown to cause problems when given to pregnant animals.
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. 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.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
This medication was given a pregnancy Category C rating because of problems seen in animal studies. When given to pregnant rabbits, high doses of Asclera increased the risk of low fetal weight and decreased the chance of fetal survival. However, the dosages were high enough to also cause toxicity in the mother rabbits.
Studies in rats revealed no similar problems. Asclera has not been studied in pregnant women, and it is not known if any similar problems would occur.
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 woman outweigh any possible risks to the unborn child.
Because Asclera is typically a cosmetic treatment and is not medically necessary, it is unlikely that the benefits would outweigh the risks, even if the risks are quite small.
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD