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Keywords:

  • antidepressants;
  • anti-epileptic drugs;
  • congenital malformation;
  • Medicines and Healthcare products Regulatory Agency;
  • US Food and Drug Administration

Key content

  • Prescription drug use during pregnancy is prevalent, with 44–99% of women being prescribed medication during pregnancy.
  • Pregnant women and their unborn children are considered a vulnerable population; recent public health scares, such as H1N1, have highlighted the need for more detailed research into medication use in pregnancy.
  • The teratogenic risk of more than 80% of 468 drugs released in the USA over the last 20 years remains to be clarified.
  • Maternal physiological changes during pregnancy can alter drug pharmacokinetics, with poorly understood effects, while placental transfer of medications may have unknown fetal consequences.
  • There is an urgent need for further research into the adverse effects of drugs used in pregnancy.

Learning objectives

  • To know about the prevalence of prescription medication use during pregnancy.
  • To be aware of the lack of safety data available on fetal adverse effects for commonly prescribed drugs.

Ethical issues

  • Drug companies are reluctant to carry out phase III clinical trials in pregnant women and they rely on animal models and post-marketing surveillance for the identification of adverse effects.
  • Is it unethical to prescribe drugs in pregnancy for which there is little concrete safety data?