This sheet is about exposure to baclofen in pregnancy and while breastfeeding. This information 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 certain muscles in the body. It has been used to treat spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or some spinal injuries. Baclofen can also be used to treat certain 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 people 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 symptoms include seizures, hallucinations, confusion, delusions, disorientation, general agitation, insomnia, dizziness, nausea, and personality changes. It is not known if or how these symptoms may 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.
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?
Every pregnancy starts out with a 3-5% chance of having a birth defect. This is called the background risk. Based on the studies reviewed, it is not known if baclofen increases the chance of birth defects above the background risk. There are several case reports of children that were exposed to baclofen during pregnancy and 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 may 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. No withdrawal symptoms have been reported in babies whose mothers were treated with baclofen by intrathecal pump.
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 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.
If a male takes baclofen, could it affect fertility (ability to get partner 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 fathers or sperm donors 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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OTIS/MotherToBaby encourages inclusive and person-centered language. While our name still contains a reference to mothers, we are updating our resources with more inclusive terms. Use of the term mother or maternal refers to a person who is pregnant. Use of the term father or paternal refers to a person who contributes sperm.