By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo

TheMediTary.Com

Medical Information, Documents, News - TheMediTary.Com

  • Home
  • News
  • Drugs
  • Drugs A-Z
  • Medical Answers
  • About Us
  • Contact
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo
Search Drugs
  • Drugs
    • Latest Drugs
    • Drugs A-Z
    • Medical Answers
  • News
    • FDA Alerts
    • Medical News
    • Health
    • Consumer Updates
    • Children's Health
  • More TheMediTary.Com
    • About Us
    • Contact
Follow US
Home > Drugs > Lacosamide (monograph) > Lacosamide (monograph) Pregnancy and Breastfeeding Warnings
Drugs

Lacosamide Pregnancy and Breastfeeding Warnings

Contents
Lacosamide (monograph) Pregnancy Warnings Lacosamide (monograph) Breastfeeding Warnings

Lacosamide (monograph) Pregnancy Warnings

Developmental toxicities have been observed in pregnant rats receiving this drug during pregnancy including increased perinatal mortality and decreased body weights. In rats and rabbits administered this drug during the period of organogenesis, no effects on fetal structure were observed however, doses were limited by maternal toxicity and embryofetal death in rats. Administration to rats during the neonatal and juvenile periods of development (generally thought to correspond to late pregnancy in humans in terms of brain development) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). In vitro data has shown this drug interferes with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential adverse effects on CNS development related to this interference cannot be ruled out. There are no controlled data in human pregnancy.

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.

Use is not recommended unless clearly needed

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

Risk Summary: There are no adequate data on the developmental risks associated with use in pregnant women; developmental toxicity (e.g., increased embryofetal and perinatal mortality, growth deficit) has been observed in animal studies.

Comments:
-There are risks related to epilepsy and antiepileptic products; effective antiepileptic therapy should not be interrupted since aggravation of the illness is detrimental to both mother and fetus.
-Pregnancy Registries:
--The North American Antiepileptic Drug (NAAED) visit http://www.aedpregnancyregistry.org or call 1-888-233-2334.
--Australian Pregnancy Register for Women on Antiepileptic Medication with Epilepsy and Allied Conditions, call 1800 069 722

See references

Lacosamide (monograph) Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-There is limited data available on use of this drug during lactation; published reports have reported this drug is excreted in breastmilk.
-Some authorities advise against maternal use while breastfeeding as a precautionary measure.

Limited data indicates low levels of this drug in human milk following a maternal dose of 200 mg/day. As with most antiepileptic drugs (AED), the relationship of maternal dose to breastmilk concentration may be variable due to need to take a combination of AEDs. Maternal weight-adjusted dosages of 1.8% and 22% have been reported. Three infants who were breastfed for 7 to 9 months while their mothers received dosages up to 400 mg/day, developed normally. Until more data are available, this drug should be used with careful monitoring, especially while nursing a newborn or preterm infant.

See references

Share this Article
Latest News
Medical News

Obesity, unhealthy lifestyles may cause heart to age by 5–45 years

May 08, 2025
Aging: As little as 5 minutes of exercise may keep the brain healthy
Prostate cancer: Simple urine test may help with early detection
Cancer treatment side effects: Exercise may reduce pain, fatigue
Alzheimer's: Exercising in middle age may reduce beta-amyloid in brain...
Heart disease: Just 3 minutes of 'incidental activity' may lower...
Related Drugs
Fidanacogene Elaparvovec
Cerave Anti-Itch
Centrum Adult
Crovalimab
Cyltezo Prefilled Syringe
Zepbound Pen
Mylanta One
Uretron Ds
Medihoney Wound And Burn Dressing
Lidotrode

Other drugs

Name Drug Class Updated
Fidanacogene Elaparvovec Drugs 03-Oct-2024
Cerave Anti-Itch Drugs 02-Oct-2024
Centrum Adult Drugs 02-Oct-2024
Crovalimab Drugs 02-Oct-2024
Cyltezo Prefilled Syringe Drugs 01-Oct-2024
Zepbound Pen Drugs 30-Sep-2024
Mylanta One Drugs 27-Sep-2024
Uretron Ds Drugs 27-Sep-2024
Medihoney Wound And Burn Dressing Drugs 26-Sep-2024
Lidotrode Drugs 26-Sep-2024
Libervant Drugs 26-Sep-2024
Moderna Covid-19 Drugs 25-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024

Categories

  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health

About US

Welcome to TheMediTary.Com

Our website provides reliable and up-to-date information on various medical topics. We empower individuals to take charge of their health by simplifying complex medical jargon and providing practical tips and advice. We prioritize the privacy and confidentiality of our users and welcome feedback to improve our services.

Website use data of FDA and other sources

DMCA.com Protection Status Truste Protection Status Trust Mark Protection Status
HONcode logo We comply with the HONcode standard for trustworthy health information.
Quick Link
  • About Us
  • Contact Us
  • Editorial Policy
  • Privacy Policy
  • Accessibility Policy
  • Terms & Conditions
  • Disclaimer
  • DMCA
  • Do Not Sell My Personal Information
  • Sitemap
  • Care Notes
  • Health Guide
  • Professional
Drugs
  • New Drugs
  • Medical Answers
  • Drugs A-Z
  • Drug Classes
  • Drug Dosage
  • Pill Identifier
  • Consumer Infor
  • Side Effects
  • Inactive Ingredients
  • Pregnancy Warnings
  • Patient Tips
  • Treatments
News
  • Latest News
  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health
Find US
  • Medium
  • Google Site
  • Blogspot
  • API
  • Reddit
  • Tumblr
  • Scoop.it
  • Substack
  • Wordpress
  • Wix
  • Behance

© 2025 TheMediTary.Com All rights reserved. Operated by