Australian Drug Categories

Introduction

Therapeutic Goods Administration logo.

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 (TGA) has classes (A, B1, B2, B3, C, D and X) to define legal drugs safety.

The original Australian Drug Evaluation Committee (ADEC) formed in 1963 was replaced in 2010 by the Advisory Committee on Prescription Medicines (ACPM).

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? USA Drug Categories)

The drug examples given on this current page are not a comprehensive list within the drug classification and are from Prescribing medicines in pregnancy.

Links: Australian Drug Categories | USA Drug Categories | Human Abnormal Development | 2010 BGD Phase 2 Tutorial - Applied Embryology and Teratology

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.

Examples: Angiotensin converting enzyme (ACE) inhibitors (captopril, cilazapril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril), Angiotensin II receptor antagonists (ARAs) (candesartan cilexetil, eprosartan, irbesartan, losartan, valsartan), Anticonvulsants / Antiepileptics (carbamazepine, phenytoin sodium, methylphenobarbitone, phenobarbitone, primidone, sodium valproate (valproic acid), lamotrigine, ethosuximide, methsuximide, phensuximide, sulthiame, vigabatrin), Antirheumatoid agents (hydroxychloroquine), Muscle relaxants (quinine), Endocrine system (estrogens conjugated, Dydrogesterone, hydroxyprogesterone, megestrol, norethisterone, Fluoxymesterone, methenolone, nandrolone, oxandrolone, oxymetholone, testosterone, Nafarelin, goserelin, Aminoglutethimide, Danazol, Gestrinone), Antimicrobials (Tetracyclines Demeclocycline, doxycycline, minocycline, tetracycline)

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.

Examples: Misoprostol, Dienoestrol, Raloxifene, Finasteride, Ribavirin, Tretinoin (Oral), Isotretinoin, sodium phosphate P³²

Additional Notes

1. Many herbal, illegal and recreational drugs do not fall into the above classifications and information about the affects on development can be found in research literature and in medical literature prepared for the general public.
2. The placenta and fetal tissues may also deal with drugs differently from adult target tissues. In particular, drugs are "cleared", metabolised and excreted, at a different (lower) rate in both the fetus and in newborn infants.

References

Search PubMed: Australian Drug Categories | Drug Categories | teratogenic drugs

External Links

• Australia Therapeutic Goods Authority
  • Advisory Committee on Prescription Medicines (ACPM)
  • Prescribing Medicines in Pregnancy
  • Therapeutic goods exempted from pregnancy classification
• USA TOXNET - Databases on toxicology, hazardous chemicals, environmental health, and toxic releases. mobile

Glossary Links

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Cite this page: Hill, M.A. (2024, May 5) Embryology Australian Drug Categories. Retrieved from https://embryology.med.unsw.edu.au/embryology/index.php/Australian_Drug_Categories

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© Dr Mark Hill 2024, UNSW Embryology ISBN: 978 0 7334 2609 4 - UNSW CRICOS Provider Code No. 00098G