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Encyclopedia > 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. Pharmacology (in Greek: pharmacon is drug, and logos is science) is the study of how chemical substances interfere with living systems. ... The term trimester redirects here. ...

Contents

United States

In 1979, the United States Food and Drug Administration (FDA) introduced a classification of foetal risks due to pharmaceuticals. This was based on a similar system that was introduced in Sweden just one year earlier. For the Smashing Pumpkins song, see 1979 (song). ... The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (humans and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and... Pharmacology (in Greek: pharmacon is drug, and logos is science) is the study of how chemical substances interfere with living systems. ... 1978 (MCMLXXVIII) was a common year starting on Sunday. ...


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 studies have failed to demonstrate a risk to the foetus 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 foetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the foetus in any trimester.
Pregnancy Category C Animal reproduction studies have shown an adverse effect on the foetus 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 foetal 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 foetal abnormalities and/or there is positive evidence of human foetal 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.

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.


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 Australian Drug Evaluation Committee or ADEC, is a committee that provides independent scientific advice to the Australian Government regarding therapeutic drugs. ...

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 foetal 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 foetal 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 foetal 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 foetal 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 which 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 Category X. In some cases Category D was assigned to a drug on the basis of suspicion.


Categorisation 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

Acetaminophen (USAN) or paracetamol (INN), is a popular analgesic and antipyretic drug that is used for the relief of fever, headaches, and other minor aches and pains. ... Paracetamol (INN) (IPA: ) or acetaminophen (USAN), is a common analgesic and antipyretic drug that is used for the relief of fever, headaches, and other minor aches and pains. ... Amoxicillin (INN) or amoxycillin (former BAN) is a moderate-spectrum β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. ... Co-amoxiclav is the British Approved Name, in the British Pharmacopoeia, for the combination antibiotic containing amoxicillin and clavulanic acid. ... Isotretinoin (INN) (IPA: ) is a medication used for the treatment of severe acne. ... Phenytoin sodium (marketed as Dilantin® in the USA and as Epanutin® in the UK, by Parke-Davis, now part of Pfizer) is a commonly used antiepileptic. ... Rifampicin (INN) (IPA: ) or rifampin (USAN) is a bacteriocidal antibiotic drug of the rifamycin group. ... // Thalidomide is a sedative, hypnotic, and anti-inflammatory medication. ... Theophylline is a methylxanthine drug used in therapy for respiratory diseases such as COPD or asthma under a variety of brand names. ... Tetracycline (INN) (IPA: ) is a broad-spectrum antibiotic produced by the streptomyces bacterium, indicated for use against many bacterial infections. ...

See also

Teratology (from the Greek teras (genitive teratos), meaning monster, and logos meaning study) is the medical study of teratogenesis or grossly deformed individuals. ...

References

  1. http://www.prn2.usm.my/mainsite/bulletin/sun/1995/sun24.html
  2. Australian categories
  3. Sannerstedt R, Lundborg P, Danielsson BR, Kihlstrom I, Alvan G, Prame B, Ridley E. Drugs during pregnancy: an issue of risk classification and information to prescribers. Drug Saf. 1996 Feb;14(2):69-77. PMID 8852521.

 
 

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