Pregnancy category

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.

Every drug has specific information listed in its product literature. In the UK, while no preset categories are applied, the British National Formulary gives a table of drugs to be avoided or used with caution in pregnancy, and does so using a limited number of key phrases.

United States
In 1979, the United States Food and Drug Administration (FDA) introduced a classification of fetal risks due to pharmaceuticals. This was based on a similar system that was introduced in Sweden one year earlier. The same guidelines are followed in India as well.

The United States FDA has the following definitions for the pregnancy categories: There is one additional category, "Pregnancy Category N", which is a transitional identification indicating that the FDA has not yet classified the drug into a specified pregnancy category.

One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be considered Pregnancy Category A in other countries are allocated to Category C by the FDA. See below.

The FDA has proposed updating its approach to labeling

Australia
Australia has a slightly different pregnancy category system from the United States - notably the subdivision of Category B. The system, as outlined below, was established by the Congenital Abnormalities Sub-committee of the Australian Drug Evaluation Committee (ADEC).

The subcategorisation of Category B, while offering additional information that may be of benefit in evaluating the risk vs benefit, presents its own problem of data reliability - since human data is lacking or inadequate, the subcategorisation is based on animal data. Furthermore, allocation of a drug in Category B does not necessarily imply greater safety than Category C.

Drugs in Category D are not absolutely contraindicated in pregnancy, unlike those of Category X. In some cases, Category D was assigned to a drug on the basis of suspicion.

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The data presented is for comparative and illustrative purposes only, and may have been superseded by updated data.