懷孕分級

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懷孕分級是藥物學中用來評估女性在懷孕期間服用藥物對胎兒可能造成傷害的危險程度，但是在母乳中出現藥物或是藥物代謝物所可能造成的傷害則不包括在懷孕分級中。

每一種藥物都會在產品說明書中註明懷孕分級資訊，在英國，當某種藥物沒有設定分類時，則參考英國國家處方集所提供的懷孕藥物列表，該表列出懷孕時應避免服用或是應小心使用的藥物。

已隱藏部分未翻譯内容，歡迎參與翻譯。

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 United States FDA has the following definitions for the pregnancy categories:

United States FDA Pharmaceutical Pregnancy Categories
Pregnancy Category A	Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Pregnancy Category B	Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Pregnancy Category C	Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Category D	There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Pregnancy Category X	Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Pregnancy Category N	FDA has not classified this drug.

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 http://edocket.access.gpo.gov/2008/pdf/E8-11806.pdf

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).

ADEC Pregnancy Categories (Australia)
Pregnancy Category A	Drugs that 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 that 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 that 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 that 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 that, 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 that 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.

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.

Germany

Category	Description
Gr 1	Extensive human tests and animal studies have not shown the drug to be embryotoxic/teratogenic.
Gr 2	Extensive human tests of the drug have not shown the drug to be embryotoxic/teratogenic.
Gr 3	Extensive human tests of the drug have not shown the drug to be embryotoxic/teratogenic. However, the drug appears to be embryotoxic/teratogenic in animals.
Gr 4	No adequate and well-controlled studies of the drug's effects on humans are available. Animal studies have shown no embryotoxic/teratogenic effects.
Gr 5	No adequate and well-controlled studies of the drug's effects on humans are available.
Gr 6	No adequate and well-controlled studies of the drug's effects on humans are available. Animal studies have shown embryotoxic/teratogenic effects.
Gr 7	There is a risk that the drug is embryotoxic / teratogenic in humans, at least in the first trimester.
Gr 8	There is a risk that the drug is toxic to fetuses throughout the second and third trimesters.
Gr 9	There is a risk that the drug causes prenatal complications or abnormalities.
Gr 10	There is a risk that the drug causes hormone specific action on the human fetus.
Gr 11	There is a known risk that the drug is a mutagen/carcinogen.

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
Acetylsalicylic acid/Aspirin	C	D
Amoxicillin	A	B
Amoxicillin with clavulanic acid	B1	B
Cefotaxime	B1	B
Diclofenac	C	C
Isotretinoin	X	X
Leflunomide	X	X
Loperamide	B3	B
Paroxetine	C	D
Phenytoin	D	D
Rifampicin	C	C
Thalidomide	X	X
Theophylline	A	C
Tetracycline	D	D
Triamcinolone (skin)	A	C

References

• Medicines in Pregnancy Working Party. Prescribing medicines in pregnancy. Australian Drug Evaluation Committee. 14 February 2007 [2008-05-21].  - links provided for 1999 4th edition and subsequent updates
• Sannerstedt R, Lundborg P, Danielsson BR; et al. Drugs during pregnancy: an issue of risk classification and information to prescribers. Drug Saf. 1996, 14 (2): 69–77. PMID 8852521. doi:10.2165/00002018-199614020-00001.  引文格式1维护：显式使用等标签 (link)
• Food and Drug Administration. Federal Register 1980;44:37434-67
• Specific requirements on content and format of labeling for human prescription drugs.. Labeling Requirements for Prescription Drugs and/or Insulin. Food and Drug Administration. April 1, 1997 [2008-05-21].