Xeomin and Pregnancy

Because of the potential risks, Xeomin (incobotulinumtoxinA) is considered a pregnancy Category C medicine, meaning it may not be safe for use during pregnancy. When this drug was given to pregnant animals, it increased the risk of miscarriages, low fetal weights, and delayed skeletal development. In general, cosmetic use of this drug during pregnancy is not recommended.

Can Pregnant Women Receive Xeomin?

Xeomin® (incobotulinumtoxinA) is a prescription injection approved for both cosmetic and medical purposes. Based on the results of animal studies, this medication may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Xeomin 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.
When given to pregnant rabbits, Xeomin increased the risk for miscarriages. When given to pregnant rats, Xeomin caused lower fetal weights and delayed skeletal development. It is unknown whether similar problems would occur in humans as well, as this medication has not been studied in pregnant women.
Even though Xeomin has not been studied in any pregnant women, there have been cases where pregnant women have accidentally been exposed to botulinum toxin through food poisoning or other accidental exposures. These cases suggest that botulinum toxin does not cross the placenta to the baby. There may be circumstances when the benefits of using Xeomin during pregnancy outweigh the possible risks. However, cosmetic use of Xeomin during pregnancy is generally not recommended.

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Last reviewed by: Kristi Monson, PharmD
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