This sheet is about exposure to baclofen in pregnancy and while breastfeeding. This information is based on published research. It should not take the place of medical care and advice from your healthcare provider.
What is baclofen?
Baclofen is a medication that has been used to help relax some of the muscles in the body. It has been used to treat spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis and spinal injuries. Baclofen has also been used to treat some cases of hiccups, autism, and alcohol use disorder. It can be taken by mouth (orally), delivered directly to the fluid around the spinal cord by a pump (intrathecal pump), or used on the skin (topically). Some brand names for baclofen are Lioresal®, Kemstro®, and Gablofen®. Topical baclofen is sold under the brand name EnorvaRX-Baclofen®.
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. If you take baclofen regularly and then suddenly stop taking it, you could have symptoms of withdrawal. Possible withdrawal symptoms could include seizures, altered states of mind or personality changes (confusion, disorientation, hallucinations, delusions, general agitation), insomnia (not being able to fall asleep or stay asleep), dizziness, and nausea. It is not known if or how these symptoms might affect a pregnancy. Your healthcare providers can talk with you about the benefits of treating your condition and the risks of untreated illness during pregnancy.
The product label for baclofen recommends women who are pregnant use caution when using this medication during pregnancy. This is because there is not enough information available on the use of baclofen to know if it could affect a pregnancy. However, the benefit of using baclofen may outweigh possible risks. Your healthcare provider can talk with you about using baclofen and what treatment is best for you.
I take baclofen. Can it make it harder for me to get pregnant?
It is not known if baclofen can make it harder to get pregnant.
Does taking baclofen increase the chance of miscarriage?
Miscarriage is common and can occur in any pregnancy for many different reasons. Studies have not been done to see if baclofen increases the chance of miscarriage.
Does taking baclofen 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 baclofen, might increase the chance of birth defects in a pregnancy.
It is not known if baclofen increases the chance of birth defects above the background risk. There are several case reports of children who were exposed to baclofen during pregnancy who did not have birth defects.
Does taking baclofen in pregnancy increase the chance of other pregnancy-related problems?
Studies have not been done to see if baclofen increases the chance for 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).
I need to take baclofen throughout my entire pregnancy. Will it cause withdrawal symptoms in my baby after birth?
The use of oral baclofen during pregnancy can cause temporary symptoms in newborns soon after birth. These symptoms are sometimes referred to as withdrawal. Symptoms might include seizures, tremors, rigidity (stiff muscles), drowsiness (being overly sleepy), dilated pupils, dry mouth, and problems feeding. Not all babies exposed to baclofen will have these symptoms. It is important that your healthcare providers know you are taking baclofen so that if symptoms occur your baby can get the care that is best for them. Withdrawal symptoms have not yet been reported in babies whose mothers were treated with baclofen by intrathecal pump. Information from one case report suggests that it takes newborns longer to clear this medication from their body than it does for adults.
Does taking baclofen in pregnancy affect future behavior or learning for the child?
Studies have not been done to see if baclofen can cause behavior or learning issues for the child.
Breastfeeding while taking baclofen:
Information on the use of baclofen during breastfeeding is limited. One study found that very low amounts of baclofen enter the breastmilk when baclofen is taken orally (by mouth). When baclofen is used topically or by intrathecal pump, even less of the medication is expected to pass into breastmilk. No harmful effects in nursing infants have been reported.
If you suspect the baby has any symptoms (drowsiness, dry mouth, tremors, rigidity, or dilated pupils), contact the child’s healthcare provider. Be sure to talk to your healthcare provider about all your breastfeeding questions.
The product label for baclofen recommends women who are breastfeeding not use this medication. This is because there is not enough information available on the use of baclofen while breastfeeding. However, the benefit of using baclofen may outweigh possible risks. Your healthcare provider can talk with you about using baclofen and what treatment is best for you.
If a man takes baclofen, could it affect fertility (ability to get a woman pregnant) or increase the chance of birth defects?
Studies have not been done to see if baclofen could affect male fertility or increase the chance of birth defects above the background risk. In general, exposures that men have are unlikely to increase 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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