THE SAFETY OF DIVALPROEX SODIUM EXTENDED RELEASE (DEPAKOTE ER) DURING PREGNANCY OR BREASTFEEDING
THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Due to an increased risk of birth defects, divalproex sodium is considered unsafe to use during pregnancy unless absolutely necessary.
What is divalproex sodium?
Divalproex sodium is an anticonvulsant medication, related to valproic acid and valproate, that is used to treat epilepsy and bipolar disorder.
What is divalproex sodium used to treat?
Divalproex sodium is a prescription medication used to treat epileptic seizures including complex partial seizures and simple/complex absence seizures, manic/mixed episodes of bipolar disorder, and to prevent migraines.
How does divalproex sodium work?
Divalproex sodium regulates the electrical activity and release of neurotransmitters in the brain to prevent seizures. Divalproex sodium extended-release is the once-a-day version of this medication.
If I am taking divalproex sodium, can it harm my baby?
Animal and human studies have linked divalproex sodium use during pregnancy with an increased risk of birth defects such as neural tube defects and decreased infant IQ. While the risk of birth defects with this medication is increased throughout pregnancy, the risk is especially significant during the first trimester of pregnancy. Other potential birth defects that have been reported with divalproex sodium include heart, face, head, skeletal, urinary, genital, and muscle defects. This medication has also been linked to an increased risk of autism. Infants who are exposed to divalproex sodium have a characteristic set of birth defects called fetal valproate syndrome. Factors that may increase the risk associated with divalproex sodium include medication dose and use with other anticonvulsant medications. Immediately after birth, infants exposed to this medication may have low blood sugar or signs of withdrawal or distress. Other anticonvulsant medications may have a lower risk of birth defects associated with their use during pregnancy.
The manufacturer of divalproex sodium warns that this medication should not be used for migraine prevention during pregnancy. Divalproex sodium is not recommended for any other indication unless the mother has no alternative medications to manage her condition. Due to the increased risk of neural tube defects, folic acid supplementation is encouraged before conception and during pregnancy in women on this medication. Prenatal testing is also encouraged in women taking this medication during pregnancy.
If I am taking divalproex sodium and become pregnant, what should I do?
An effective form of birth control is recommended in women on divalproex sodium therapy to avoid pregnancy. If a woman is planning to become pregnant, divalproex sodium should be tapered off and stopped (avoid stopping suddenly). Divalproex sodium should only be continued in pregnancy if it is considered absolutely necessary. If you become pregnant while taking divalproex sodium, it is important to speak with your doctor immediately to discuss whether or not to discontinue the medication. Prenatal testing may be recommended.
If I am taking divalproex sodium, can I safely breastfeed my baby?
Divalproex sodium can pass through breast milk. Concentrations of this medication in breast milk are expected to be 1% to 10% of the mother’s dose. Divalproex sodium is generally considered compatible with breastfeeding; however, infants should be monitored for side effects. Breastfed infants may be at risk of liver toxicity or blood clotting issues so infants should be monitored if breastfeeding.
If I am taking divalproex sodium, will it be more difficult to get pregnant?
Animal studies have noted reduced sperm production and shrinking of the testicles in males exposed to divalproex sodium. Studies have linked divalproex sodium use in women with disorders of the ovaries. This medication may also disrupt hormones in men and women.
If I am taking divalproex sodium, what should I know?
Divalproex sodium is linked to an increased risk of neural tube defects and decreased infant IQ. It is not recommended during pregnancy unless other treatment options are unavailable. It can be continued in women who breastfeed, but monitoring breastfed infants for side effects is encouraged.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of anticonvulsants during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about epilepsy here, reports about bipolar disorder here, and reports about the individual medications used to treat seizure disorders here. Additional information can also be found in the resources below.
For more information about divalproex sodium during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
RXAbbvie: Depakote ER Prescribing Information