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
- Category A
Taken by large number of women without detrimental effects.
- Category B
Taken by a limited number of women without detrimental effect. Subclassified by results from animal studies into:
- Category B1
Animal studies show no evidence of detrimental effect to the foetus.
- Category B2
Animal studies are inadequate or lacking, but available data shows no evidence of detrimental effect to the foetus.
- Category B3
Animal studies show evidence of foetal damage, but the significance of this in humans is unknown.
- Category B1
- 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
- Australian categorisation system for prescribing medicines in pregnancy. Therapeutic Goods Administration.