Skip to Content

Brivaracetam Pregnancy and Breastfeeding Warnings

Brivaracetam is also known as: Briviact

Medically reviewed on May 25, 2018

Brivaracetam Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: There are no adequate data on developmental risks associated with this drug in pregnant women; based on animal data, may cause fetal harm.

Comments:
-Women of childbearing potential should discuss family planning and contraception with their healthcare provider.
-Infants born to mothers receiving anti-epileptic drugs have 2 to 3 times the prevalence of malformations compared to the general population. There is an even greater risk with polytherapy; however, the extent to which the treatment and/or the underlying condition is responsible has not been elucidated.
-Discontinuation of anti-epileptic drugs may result in exacerbation of the disease which could be harmful to the mother and the fetus.

Evidence of developmental toxicity has been observed in animal studies at doses that were also maternally toxic. In rabbits, increased embryofetal mortality and decreased fetal body weight were observed, while in rats, decreased growth, delayed sexual maturation, and long-term neurobehavioral changes occurred. This drug appears to readily cross the placenta in pregnant rats. There are no adequate and well controlled studies in human pregnancy.

For patients taking antiepileptic drugs during pregnancy, physician/patients should be encouraged to enroll patients in pregnancy registries to monitor pregnancy outcomes:
-North American Antiepileptic Drug (NAAED) Pregnancy Registry; Phone:1-888-223-2334; Website: http://www.aedpregnancyregistry.org/
-Australian Pregnancy Register for Women on Antiepileptic Medication with Epilepsy and Allied Conditions; Phone: 1800 069 722

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Brivaracetam Breastfeeding Warnings

Following a single oral dose of radiolabeled drug to lactating rats, radioactivity was secreted into rat milk and rapidly reached levels similar to those in plasma.

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No information is available on the effects in the breastfed infant, or the effects of the drug on milk production.
-Some authorities recommend a decision should be made whether to discontinue nursing or discontinue drug, taking into account the benefit of the drug to the mother.

See references

References for pregnancy information

  1. "Product Information. Briviact (brivaracetam)." UCB Pharma Inc, Smyrna, GA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Briviact (brivaracetam)." UCB Pharma Inc, Smyrna, GA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide