Talk:Australian Drug Categories: Difference between revisions
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[http://www.tga.gov.au/archive/committees-adec.htm Australian Drug Evaluation Committee (ADEC)] 1963. | [http://www.tga.gov.au/archive/committees-adec.htm Australian Drug Evaluation Committee (ADEC)] 1963. | ||
{{Australian Drug Categories}} | |||
==Australian Drug Categories== | |||
Legal drugs are classified, usually by each country's appropriate regulatory body, on the safety of drugs during pregnancy. In Australia, the Therapeutic Goods Authority has classes (A, B1, B2, B3, C, D and X) to define their safety. In the USA, drugs are classified by the Food and Drug Administration (FDA) into classes (A, B, C, D, and X) to define their safety. (More? [[Australian Drug Categories]]) | |||
* '''Pregnancy Category A''' - 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''' - 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''' - 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''' - 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''' - 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''' - 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. | |||
==2011== | ==2011== | ||
Revision as of 17:59, 6 April 2016
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Cite this page: Hill, M.A. (2024, May 18) Embryology Australian Drug Categories. Retrieved from https://embryology.med.unsw.edu.au/embryology/index.php/Talk:Australian_Drug_Categories |
Australian Drug Evaluation Committee (ADEC) 1963.
| Australian Drug Categories |
|---|
| Legal drugs are classified, usually by each country's appropriate regulatory body, on the safety of drugs during pregnancy. In Australia, the Therapeutic Goods Authority has classes (A, B1, B2, B3, C, D and X) to define their safety. In the USA, drugs are classified by the Food and Drug Administration (FDA) into classes (A, B, C, D, and X) to define their safety. (More? Australian Drug Categories)
|
Australian Drug Categories
Legal drugs are classified, usually by each country's appropriate regulatory body, on the safety of drugs during pregnancy. In Australia, the Therapeutic Goods Authority has classes (A, B1, B2, B3, C, D and X) to define their safety. In the USA, drugs are classified by the Food and Drug Administration (FDA) into classes (A, B, C, D, and X) to define their safety. (More? Australian Drug Categories)
- Pregnancy Category A - 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 - 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 - 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 - 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 - 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 - 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.
2011
A to X: the problem of categorisation of drugs in pregnancy--an Australian perspective
Med J Aust. 2011 Nov 21;195(10):572-4.
Kennedy DS. Source MotherSafe, Royal Hospital for Women, Sydney, NSW, Australia. debra.kennedy@sesiahs.health. nsw.gov.au Comment in Med J Aust. 2012 Feb 20;196(3):172; author reply 172-3. Med J Aust. 2012 Feb 20;196(3):172-3.
PMID 22106996
