In animal studies on pregnancy and Botox, the drug caused low fetal birth weight, delayed bone development, and miscarriages. However, when pregnant women have been exposed to the botulinum toxin through food poisoning or accidental ingestion, no ill effects were seen in the fetus.
Is Botox Safe During Pregnancy?
Botox® (onabotulinumtoxinA, previously known as botulinum toxin type A) is a prescription medication approved for various cosmetic and medical purposes. The drug may not be safe for use during pregnancy, although the full risks are unknown.
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 that 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 to pregnant mice and rats, Botox increased the risk of low fetal weight and delayed bone development. When given to pregnant rabbits, the drug caused miscarriages and birth defects. However, it seems that rabbits are rather sensitive to the effects of Botox.
Even though this drug has not been studied in any pregnant women, there have been cases when 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, and there may be circumstances when the risks of using Botox in pregnancy are outweighed by the possible benefits. However, cosmetic use of the drug during pregnancy is generally not recommended.
Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: onabotulinumtoxinA (marketed as Botox/Botox Cosmetic), abobotulinumtoxinA (marketed as Dysport), and rimabotulinumtoxinB (marketed as Myobloc) (8/3/2009). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174949.htm. Accessed August 21, 2009.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 7th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2005.
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