Drugs in Pregnancy

The Therapeutic Goods Administration classifies drugs for suitability in pregnancy based on the potential of a drug to cause:

  • Birth defects
  • Detrimental effects at birth
  • Problems in later life

The classification system is:

  • Valid only for the dose and route of administration listed
    • Does not apply in overdose
  • Not hierarchical
    • 'B' drugs are not safer than 'C' drugs

Categories

  • Category A
    Taken by large number of women without detrimental effects.
  • Category B
    Subclassified into:
    • Category B1
      • Taken by a limited number of women without detrimental effect
      • Animal studies show no evidence of detrimental effect to the foetus
    • Category B2
      • Taken by a limited number of women without detrimental effect
      • Animal studies are inadequate or lacking, but available data shows no evidence of detrimental effect to the foetus
    • Category B3
      • Taken by a limited number of women without detrimental effect
      • Animal studies show evidence of foetal damage, but the significance of this in humans is unknown
  • Category C
    • Drugs which have caused (or a suspected to cause) detrimental foetal effects, but without malformations
    • These effects may be reversible
  • Category D

    • Drugs which have caused (or are suspected to cause) an increased incidence of foetal malformations or damage
    • May also have detrimental effects
  • Category X

    • Drugs which have a high risk of causing permanent damage
    • Should not be used in pregnancy, or when pregnancy is possible

References

  1. Australian categorisation system for prescribing medicines in pregnancy. Therapeutic Goods Administration.
Last updated 2017-09-23

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