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Perampanel and pregnancy.

Blanca Vazquez1, Torbjörn Tomson2, Cindy Dobrinsky3

  • 1NYU Langone Comprehensive Epilepsy Center, New York, New York, USA.

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|March 5, 2021
PubMed
Summary

Maternal perampanel exposure during pregnancy showed potential risks in preclinical studies. Clinical data suggest decreased drug exposure in late pregnancy, but more outcome data are needed.

Keywords:
adverse eventsepilepsyperampanelphysiologically based pharmacokineticspregnancy

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Area of Science:

  • Obstetrics and Gynecology
  • Pharmacology and Toxicology
  • Neonatal Health

Background:

  • Perampanel is an antiepileptic drug.
  • Understanding its safety during pregnancy is crucial for maternal and fetal well-being.
  • Limited data exist on perampanel's effects during gestation.

Purpose of the Study:

  • To summarize pregnancy and fetal/postnatal outcomes of maternal perampanel exposure.
  • To utilize physiologically based pharmacokinetic (PBPK) modeling to understand perampanel pharmacokinetics (PK) during pregnancy.

Main Methods:

  • Preclinical studies in pregnant rats and rabbits.
  • Collated clinical data from a global safety database (post-marketing, interventional, and routine settings).
  • Physiologically based pharmacokinetic (PBPK) modeling to predict perampanel PK throughout pregnancy.

Main Results:

  • Preclinical studies indicated potential post-implantation loss and physical development delays.
  • 96 pregnancies reported; 43 reached full term with normal live births.
  • Five neonates had adverse events; PK simulations showed decreased perampanel exposure in late pregnancy.

Conclusions:

  • Preliminary data on perampanel use in pregnancy are available.
  • Caution is advised due to potential risks and limited follow-up.
  • Further data are required to determine the prevalence of adverse pregnancy outcomes.