This sheet is about exposure to onabotulinumtoxinA in pregnancy and while breastfeeding. This information is based on published research studies. It should not take the place of medical care and advice from your healthcare provider.
What is onabotulinumtoxinA?
OnabotulinumtoxinA (formerly called botulinum toxin type A) has been used to treat migraine headaches, excessive sweating, muscle spasms or stiffness, eye muscle conditions (such as crossed eyes, eyelid twitching), and urinary leakage. It is also used cosmetically to reduce the look of wrinkles. It is injected into the skin or muscle. Some brand names include Botox® or Botox Cosmetic®, and Oculinum®.
There are also other forms of botulinum toxin that are used for cosmetic and medical reasons. Some brands names are Dysport®, Xeomin®. These products have not been studied for use in pregnancy. It is not known how the information about using these products might be the same or different from the information about using onabotulinumtoxinA.
Sometimes when women find out they are pregnant, they think about changing how they take their medication, or stopping their medication altogether. However, it is important to talk with your healthcare providers before making any changes to how you take this medication. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
I get onabotulinumtoxinA treatments, but I would like to stop before becoming pregnant. How long does the drug stay in my body?
The time it takes the body to metabolize (to process) medication is not the same for everyone. In healthy non-pregnant adults, it has been suggested that onabotulinumtoxinA stays in the body for about 4-6 months.
I get onabotulinumtoxinA treatments. Can they make it harder for me to get pregnant?
It is not known if onabotulinumtoxinA can make it harder to get pregnant. Because onabotulinumtoxinA does not appear to get into the bloodstream, it is not expected to affect the ability to get pregnant.
Does getting onabotulinumtoxinA treatments increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. A report from the manufacturer did not find an increased chance for miscarriage. Other studies have not been done to see if onabotulinumtoxinA increases the chance of miscarriage. Because onabotulinumtoxinA does not appear to get into the bloodstream, it is not expected to increase the chance of miscarriage.
Does getting onabotulinumtoxinA treatments increase the chance of birth defects?
Birth defects can happen in any pregnancy for different reasons. Out of all babies born each year, about 3 out of 100 (3%) will have a birth defect. We look at research studies to try to understand if an exposure, like onabotulinumtoxinA, might increase the chance of birth defects in a pregnancy.
A limited number of research studies did not report an increased chance of birth defects with onabotulinumtoxinA treatments during pregnancy. A report from the manufacturer, which included pregnancies exposed to onabotulinumtoxinA either during pregnancy or a few months before getting pregnant, did not report an increased chance of birth defects. Because onabotulinumtoxinA does not appear to get into the bloodstream, it is not expected to increase the chance of birth defects.
Does getting onabotulinumtoxinA treatments in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if onabotulinumtoxinA can increase the chance of pregnancy-related problems such as preterm delivery (birth before week 37) or low birth weight (weighing less than 5 pounds, 8 ounces [2500 grams] at birth). A report from the manufacturer did not find a higher chance of preterm delivery. Because onabotulinumtoxinA does not appear to get into the bloodstream, it is not expected to increase the chance of pregnancy-related problems.
Does getting onabotulinumtoxinA treatments in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if onabotulinumtoxinA can increase the chance of behavior or learning issues for the child. Because onabotulinumtoxinA does not appear to get into the bloodstream, it is not expected to increase the chance of effects on behavior or learning in the child.
Breastfeeding while getting onabotulinumtoxinA treatments:
OnabotulinumtoxinA is not expected to pass into breast milk. Limited research studies on cosmetic injections of onabotulinumtoxinA while breastfeeding did not detect onabotulinumtoxinA in breast milk. In breastfed children whose mothers were getting onabotulinumtoxinA injections, no side effects were reported. Be sure to talk to your healthcare provider about all your breastfeeding questions.
If a man gets onabotulinumtoxinA treatments, could it affect his fertility or increase the chance of birth defects?
Studies have not been done to see if onabotulinumtoxinA could affect a man’s fertility (ability to make healthy sperm) or increase the chance of birth defects. In general, exposures that men have are unlikely to increase the risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/.
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