Skin Home > Picato and Pregnancy

When the active ingredient in Picato (ingenol mebutate) was given to pregnant animals, it appeared to increase the risk for fetal deaths and malformations. Due to these risks, the FDA classified Picato as a pregnancy Category C medicine, meaning it may not be safe for use by pregnant women. However, there may be times where the benefits of the drug outweigh the risks.

Can Pregnant Women Use Picato?

Picato® (ingenol mebutate) is a prescription medication used to treat a precancerous skin condition known as actinic keratosis, or solar keratosis. It is unclear if this medication is safe for use during pregnancy, as the full risks are currently unknown.
 

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 used during pregnancy. Picato is classified as a pregnancy Category C drug.
 
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.
 
When ingenol mebutate, the active ingredient in Picato, was given intravenously (by IV) to pregnant rats, no problems were seen in the fetal rats. When the drug was given by IV to pregnant rabbits, it increased the risk for fetal deaths and fetal malformations.
 
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.
 
Keep in mind that with normal skin use, a fetus would be exposed to a very small amount, if any, of the drug.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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