Pregnancy category

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast milk.

United States

The United States Food and Drug Administration (FDA)-assigned pregnancy categories as used in the Drug Formulary are outlined as follows:

United States FDA Pharmaceutical Pregnancy Categories
Pregnancy Category A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.
Pregnancy Category B Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
Pregnancy Category C Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category D There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Pregnancy Category X Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Drugs Labelled as Category A

Drugs Labelled as Category B

Drugs Labelled as Category C

Drugs Labelled as Category D

Drugs Labelled as Category X

Australia

The Australian Therapeutic Goods Administration (TGA) categorization system differs from the US FDA categorization:

  • The categorization of medicines for use in pregnancy does not follow a hierarchical structure.
  • Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories.
  • Subcategorization of the B category is based on animal data.
  • The allocation of a B category does not imply greater safety than a C category.
  • Medicines in category D are not absolutely contraindicated during pregnancy (e.g.anticonvulsants).

The TGA-assigned pregnancy drug categories are outlined as follows:

ADEC Pregnancy Categories (Australia)
Pregnancy Category A Drugs which have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Pregnancy Category B1 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
Pregnancy Category B2 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Pregnancy Category B3 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Pregnancy Category C Drugs which, owing to their pharmaceutical effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible.
Pregnancy Category D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
Pregnancy Category X Drugs that have such a high risk of causing permanent damage to the fetus that they should NOT be used in pregnancy or when there is a possibility of pregnancy.

Categorization of Selected Agents

The data presented is for comparative and illustrative purposes only, and may have been superseded by updated data.

Classification of some agents, based on different national bodies
Pharmaceutical agent Australia United States
Acetaminophen/Paracetamol A B
Amoxicillin A B
Amoxicillin with clavulanic acid B1 B
Isotretinoin X X
Phenytoin D D
Rifampicin C C
Thalidomide X X
Theophylline A C
Tetracycline D D

References

  1. Australian Therapeutic Goods Administration (TGA) categorization system
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