Congenital malformations

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Although we tend to be reluctant in exposing mother and child to drugs, treatment with medicinal products during pregnancy cannot always be avoided. In the past decades several safety issues occurred that highlighted the need for special attention for the use of medicinal products during pregnancy. Whether or not a drug causes a potential teratogenic effect depends on several factors. Moreover, effects may be visible at birth, but may also become apparent later in life, among which developmental disorders. Before marketing of a drug the information about the safety in pregnancy is sparse and mainly limited to animal studies and scarce observational data. Clinical trials carried out before marketing, rarely include pregnant women, except when the product is specifically intended to be used in pregnancy. For the most part, effects of drug use during pregnancy can only be identified after marketing of the drug and when used by pregnant women. The optimal method for evaluating the risk of exposure to drugs in pregnancy strongly depends on the stage of drug development. Preapproval data on risks during pregnancy is limited and most information in this phase comes from embryo-fetal toxicity studies in animals. In the post-marketing phase observational studies are preferred. Next to the clinical presentation, epidemiology, and mechanisms of congenital malformations, the most prominent study types used in the premarketing phase; case reports and case series, cohort- and case control studies, will be discussed. Subsequently, possible ways to study the safety of drugs after marketing will be highlighted as well as current regulations for monitoring drug safety during pregnancy will be addressed.
Original languageEnglish
Title of host publicationEvidence-Based Pharmacovigilance
Subtitle of host publicationClinical and Quantiative Aspects
EditorsAndrew Bate
Place of PublicationNew York, NY
PublisherHumana Press
Number of pages16
ISBN (Electronic)978-1-4939-8818-1
ISBN (Print)978-1-4939-8816-7
Publication statusPublished - 28-Nov-2018

Publication series

NameMethods in Pharmacology and Toxicology
PublisherHumana Press Inc.
ISSN (Print)1557-2153
ISSN (Electronic)1940-6053


  • Congenital malformations
  • Developmental disorders
  • Observational studies
  • Pregnancy
  • Teratology
  • angiotensin receptor antagonist
  • diethylstilbestrol
  • dipeptidyl carboxypeptidase inhibitor
  • etretin
  • etretinate
  • folic acid
  • lenalidomide
  • nonsteroid antiinflammatory agent
  • quinoline derived antiinfective agent
  • retinoid derivative
  • teratogenic agent
  • thalidomide
  • valproic acid
  • clinical outcome
  • congenital malformation
  • developmental disorder
  • disease course
  • disease predisposition
  • drug marketing
  • drug monitoring
  • drug safety
  • drug surveillance program
  • embryotoxicity
  • fetotoxicity
  • health program
  • human
  • neural tube defect
  • nonhuman
  • patient safety
  • perinatal drug exposure
  • population based case control study
  • postmarketing surveillance
  • practice guideline
  • pregnant woman
  • priority journal
  • risk assessment
  • risk factor
  • spontaneous abortion
  • stillbirth
  • teratogenicity

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