Australian Drug Categories: Difference between revisions
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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. | 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. | ||
==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. | 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. | 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. | 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. | ||
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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. | 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. | 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. | 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. | 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. | ||
'''Links:''' [http://embryology.med.unsw.edu.au/Defect/drugs.htm Abnormal Development - Drugs] | [http://embryology.med.unsw.edu.au/Defect/drugs.htm#Australian_Fetal_Risk_Categories Australian Fetal Risk Categories] | [http://embryology.med.unsw.edu.au/Defect/drugs.htm#FDA_Fetal_Risk_Categories USA FDA Fetal Risk Categories] | [http://www.tga.gov.au/ Therapeutic Goods Authority] | [http://www.tga.gov.au/docs/html/adec/adec.htm Australian Drug Evaluation Committee (ADEC)] | [http://www.tga.gov.au/docs/html/medpreg.htm Prescribing Medicines in Pregnancy] | [http://www.tga.gov.au/docs/html/mip/exempt.htm Appendix A: Therapeutic goods exempted from pregnancy classification] | | '''Links:''' [http://embryology.med.unsw.edu.au/Defect/drugs.htm Abnormal Development - Drugs] | [http://embryology.med.unsw.edu.au/Defect/drugs.htm#Australian_Fetal_Risk_Categories Australian Fetal Risk Categories] | [http://embryology.med.unsw.edu.au/Defect/drugs.htm#FDA_Fetal_Risk_Categories USA FDA Fetal Risk Categories] | [http://www.tga.gov.au/ Therapeutic Goods Authority] | [http://www.tga.gov.au/docs/html/adec/adec.htm Australian Drug Evaluation Committee (ADEC)] | [http://www.tga.gov.au/docs/html/medpreg.htm Prescribing Medicines in Pregnancy] | [http://www.tga.gov.au/docs/html/mip/exempt.htm Appendix A: Therapeutic goods exempted from pregnancy classification] | | ||
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[[Category:Abnormal Development]] [[Category:Environmental Abnormalities]] [[Category:Human Embryo]] [[Category:Human Fetus]] | |||
Revision as of 11:01, 27 March 2010
Introduction
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.
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.
Links: Abnormal Development - Drugs | Australian Fetal Risk Categories | USA FDA Fetal Risk Categories | Therapeutic Goods Authority | Australian Drug Evaluation Committee (ADEC) | Prescribing Medicines in Pregnancy | Appendix A: Therapeutic goods exempted from pregnancy classification |
Glossary Links
- Glossary: A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | Numbers | Symbols | Term Link
Glossary Comments
Use this page to access brief definitions of specific embryology terms. Additional information can be accessed from links listed at the end of each definition. Glossary from the UNSW Embryology program compiled and written by Dr Mark Hill. Reference material used in preparing this glossary list includes: texts listed on page 1 "Reading" of each notes section, Department of Anatomy Publications, WWW resources from NCBI, NIH, OMIM, NHMRC (Australia), AMA (USA), Office of Rare Diseases (USA), PubMed Medline Dictionaries, MSDS, Merck Manual home edn. and WHO ART terminology (2009).
These notes are for Educational Purposes Only Please email Dr Mark Hill if you wish to make a comment about this current project.
