Last update July 16, 2022

Levetiracetam

Low Risk

Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Piracetam analog, nootropic and antiepileptic, authorized for use in Europe in infants from 1 month of life. Twice daily oral administration.

It is excreted in human milk in small amounts, much lower than the dose used in newborns and infants (Kohn 2016, Tomson 2007, Johannesson 2005, Greenhill 2004, Kramer 2002), however, higher levels have also been found in human milk that exceed the safe limit of 10% of the relative infant dose, RID.(Dinavitser 2022 & 2021, Kohn 2016)

Infant plasma levels are very low or undetectable. (Kacirova 2021, Paret 2014, Tomson 2007, Johannesson 2005, Kramer 2002).

In a comprehensive review, infant serum levels were 5 to 7 times lower than maternal levels and were below the reference range used for treatment. (Kacirova 2021)

No problems have been observed in infants whose mothers took it (Dinavitser 2019, Lattanzi 2017, Tomson 2007, Johannesson 2005), except for hypotonia in a 7-day-old preterm, somnolence in three fully breastfed infants (Dinavitser 2022) and sedation and vomiting in a 25-day-old infant, whose mothers also took other antiepileptic drugs. (Paret 2014, Kramer 2002)

In one study, 15% of infants had sedation that resolved with partial breastfeeding. All infants gained well in weight. (Dinavitser 2022 & 2021)

Seizures such as neonatal withdrawal syndrome have been described in a non-breastfed newborn whose mother took Levetiracetam and phenobarbital during pregnancy. Symptoms disappeared when breastfeeding began. (Rauchenzauner 2011)

Levetiracetam serum levels decrease by 50% during pregnancy due to accelerated renal elimination. After delivery, concentrations rise to pre-pregnancy levels within a week, so it is advisable to decrease the dose administered to the mother and to monitor the newborn's clinical status. (Reimers 2014, Lopez 2009, Harden 2009, Westin 2008, Tomson 2007)

Various experts consider the use of this medication compatible or very likely compatible during breastfeeding. (Hale 2019, Crettenand 2018, Briggs 2017, Rapcencu 2012, O'Connor 2009, Schaefer 2007, Pennell 2006, Pack 2006, Crawford 2008 and 2005, Greenhill, 2004)

It is recommended to observe for sedation of infants. The transitional shift to partial breastfeeding can solve this problem.(Dinavitser 2022 & 2021)

Alternatives

  • Carbamazepine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Gabapentin ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Lamotrigine (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)
  • Valproic Acid, Valproate ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Levetiracetam in other languages or writings:

Group

Levetiracetam belongs to this group or family:

Tradenames

Main tradenames from several countries containing Levetiracetam in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 170 daltons
Protein Binding 10 %
VD 0.5 - 0.7 l/Kg
Tmax 1.3 hours
6 - 8 hours
M/P ratio 0.9 - 1.14 -
Theoretical Dose 5.39 ± 1.96 mg/Kg/d
Relative Dose 13.8 ± 3.1 (4 - 20) %
Ped.Relat.Dose 5 - 30 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. Dinavitser N, Kohn E, Berlin M, Brandriss N, Bar-Chaim A, Keidar R, Livne A, Stepensky D, Berkovitch M, Sheinberg R. Levetiracetam in lactation: How much is excreted into human breast milk? Br J Clin Pharmacol. 2022 Jan;88(1):199-205. Consulted on Feb. 16, 2022 Abstract Full text (link to original source)
  3. Kacirova I, Grundmann M, Brozmanova H. Umbilical Cord, Maternal Milk, and Breastfed Infant Levetiracetam Concentrations Monitoring at Delivery and during Early Postpartum Period. Pharmaceutics. 2021 Mar 17;13(3). pii: 398. Abstract
  4. Dinavitser N, Kohn E, Berlin M, Brandriss N, Bar-Chaim A, Keidar R, Livne A, Stepensky D, Berkovitch M, Sheinberg R. Levetiracetam in Lactation: How Much is Excreted into the Human Breast Milk? Br J Clin Pharmacol. 2021 Jun 15. doi: 10.1111/bcp.14940. Epub ahead of print. PMID: 34131926. Abstract
  5. Dinavitser N, Kohn E, Berlin M, Livne A, Keidar R, Ben-Nun L, Agajani N, Sheinberg R, Gamsu S, Flor-Hirsch S, Brandriss N, Bar-Chaim A, Stepenski D, Berkovitch M. Levetiracetam monitoring in breast-milk: high inter-individual variability. Arch Dis Child 2019;104:14. Abstract 031. doi:10.1136/archdischild-2019-esdppp.31 Full text (link to original source) Full text (in our servers)
  6. Crettenand M, Rossetti AO, Buclin T, Winterfeld U. [Use of antiepileptic drugs during breastfeeding : What do we tell the mother?] Nervenarzt. 2018 Abstract
  7. Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Lacosamide during pregnancy and breastfeeding. Neurol Neurochir Pol. 2017 May - Jun;51(3):266-269. Abstract
  8. Kohn E, Brandriss N, Soback S, Bar-Haim A, Berkovitch M. Levetiracetam and lamotrigine excretion in breast milk. Reprod Toxicol. 2016;60:184. 2016
  9. Jacob S, Nair AB. An Updated Overview on Therapeutic Drug Monitoring of Recent Antiepileptic Drugs. Drugs R D. 2016 Abstract Full text (link to original source) Full text (in our servers)
  10. Paret N, Gouraud A, Bernard N, Bruel M, Cottin J, Descotes J, Vial T. Long-term follow-up of infants exposed to levetiracetam during breastfeeding: Comparison to a control group. (The 2nd International OTIS-ENTIS Conference at The Hospital for Sick Children, Toronto, Canada) Birth Defects Res A Clin Mol Teratol. 2014;100:537-8. Abstract 38. DOI: doi:10.1002/bdra.23258 2014
  11. Agencia europea del medicamento. Levetiracetam. Ficha técnica. 2014 Full text (in our servers)
  12. European Medicines Agency. Levetiracetam. Drug summary 2014 Full text (in our servers)
  13. Reimers A. New antiepileptic drugs and women. Seizure. 2014 Abstract Full text (link to original source) Full text (in our servers)
  14. Rapcencu AE, Lindhout D, Bulk S. Frequently asked questions on epilepsy, pregnancy and lactation: a EURAP-NL report. Seizure. 2012 Abstract Full text (link to original source) Full text (in our servers)
  15. Rauchenzauner M, Kiechl-Kohlendorfer U, Rostasy K, Luef G. Old and new antiepileptic drugs during pregnancy and lactation--report of a case. Epilepsy Behav. 2011 Abstract
  16. O'Connor SE, Zupanc ML. Women and epilepsy. J Pediatr Pharmacol Ther. 2009 Abstract Full text (link to original source) Full text (in our servers)
  17. Crawford PM. Managing epilepsy in women of childbearing age. Drug Saf. 2009 Abstract
  18. Harden CL, Pennell PB, Koppel BS, Hovinga CA, Gidal B, Meador KJ, Hopp J, Ting TY, Hauser WA, Thurman D, Kaplan PW, Robinson JN, French JA, Wiebe S, Wilner AN, Vazquez B, Holmes L, Krumholz A, Finnell R, Shafer PO, Le Guen C; American Academy of Neurology; et al. Practice parameter update: management issues for women with epilepsy--focus on pregnancy (an evidence-based review): vitamin K, folic acid, blood levels, and breastfeeding: report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of... Neurology. 2009 Abstract Full text (link to original source) Full text (in our servers)
  19. López-Fraile IP, Cid AO, Juste AO, Modrego PJ. Levetiracetam plasma level monitoring during pregnancy, delivery, and postpartum: clinical and outcome implications. Epilepsy Behav. 2009 Abstract
  20. Westin AA, Reimers A, Helde G, Nakken KO, Brodtkorb E. Serum concentration/dose ratio of levetiracetam before, during and after pregnancy. Seizure. 2008 Mar;17(2):192-8. Abstract
  21. Tomson T, Palm R, Källén K, Ben-Menachem E, Söderfeldt B, Danielsson B, Johansson R, Luef G, Ohman I. Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation. Epilepsia. 2007 Jun;48(6):1111-6. Epub 2007 Mar 22. Abstract Full text (link to original source) Full text (in our servers)
  22. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, second edition. London. 2007
  23. Pennell PB. 2005 AES annual course: evidence used to treat women with epilepsy. Epilepsia. 2006 Abstract Full text (link to original source) Full text (in our servers)
  24. Pennell PB. Is breast milk the best for babies of mothers on levetiracetam? Epilepsy Curr. 2006 Abstract
  25. Pack AM. Therapy insight: clinical management of pregnant women with epilepsy. Nat Clin Pract Neurol. 2006 Abstract
  26. Crawford P. Best practice guidelines for the management of women with epilepsy. Epilepsia. 2005 Abstract Full text (link to original source) Full text (in our servers)
  27. O'Brien MD, Gilmour-White SK. Management of epilepsy in women. Postgrad Med J. 2005 Abstract Full text (link to original source) Full text (in our servers)
  28. Johannessen SI, Helde G, Brodtkorb E. Levetiracetam concentrations in serum and in breast milk at birth and during lactation. Epilepsia. 2005 May;46(5):775-7. Abstract Full text (link to original source) Full text (in our servers)
  29. Tomson T. Gender aspects of pharmacokinetics of new and old AEDs: pregnancy and breast-feeding. Ther Drug Monit. 2005 Abstract
  30. Greenhill L, Betts T, Yarrow H et al. Breast milk levels of levetiracetam after delivery. Epilepsia. 2004;45 (suppl 7):230. Abstract 2115. 2004 Full text (in our servers)
  31. Pennell PB. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology. 2003 Abstract
  32. Kramer G, Hosli I, Glanzmann R et al. Levetiracetam accumulation in human breast milk. Epilepsia. 2002;43 (Suppl 7):105. Abstract 1288. 2002 Full text (in our servers)

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