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Related Experiment Videos

Atenolol developmental toxicity: animal-to-human comparisons.

Sonia Tabacova1, Carole A Kimmel, Kelly Wall

  • 1Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA. tabacovas@cder.fda.gov

Birth Defects Research. Part A, Clinical and Molecular Teratology
|June 12, 2003
PubMed
Summary

Atenolol, a beta-blocker for pregnancy hypertension, shows similar developmental toxicity in animals and humans, with humans being more sensitive. Animal models accurately predict atenolol

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Area of Science:

  • Pharmacology
  • Developmental Toxicology
  • Reproductive Medicine

Background:

  • Atenolol is a beta-adrenoreceptor blocker prescribed for hypertension during pregnancy.
  • Beta-blockers, including atenolol, are associated with potential fetal harm, such as reduced birth weight.
  • Evaluating developmental toxicity of atenolol in pregnant women and animal models is crucial.

Purpose of the Study:

  • To assess and compare the developmental toxicity of atenolol in humans and animal models.
  • To evaluate published human and animal evidence regarding atenolol's effects on fetal development.
  • To compare the manifestations of atenolol-induced developmental toxicity across species.

Main Methods:

  • Comparative analysis of pharmacokinetic and pharmacodynamic characteristics.

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  • Evaluation of the type of adverse outcomes observed.
  • Comparison of lowest adverse effect levels and the specificity of atenolol's effects.

    • Main Results:

    • Prenatal toxicity manifestations (placental changes, intrauterine growth retardation, altered fetal weight) are similar in rats, rabbits, and humans.
    • Humans appear more sensitive, with adverse effects occurring at lower doses than in animal models.
    • In rats and humans, effects occur at non-maternally toxic doses; in rabbits, effects are seen only at maternally toxic doses.

    Conclusions:

    • Animal models demonstrate concordance with humans regarding the nature of atenolol prenatal toxicity.
    • Animal models accurately predicted developmental toxicity, including placental changes and growth retardation, without structural malformations.
    • Observed intrauterine growth retardation in humans aligns with animal model predictions, with no structural abnormalities reported thus far.