Prescription ,Over the Counter (OTC) and Complementary Medication /

Risk Categories for Medication

01 In Brief

The Australian Drug Evaluation Committee of the Therapeutics Goods Administration has published an online guide "Prescribing medicines in pregnancy database" that  details risk categories for drugs taken in pregnancy. It includes all the commonly prescribed medications and their risk against a seven-point scale. It is a useful guide for health professionals and clients alike.

02 What Do I Need To Know?

• Drugs are categorised into seven groups according to associated risk. The categorisation applies only to the therapeutic dose. These categories are a useful guide for health professionals prescribing medication to pregnant women.  
• The guide takes into account the known harmful effects of medication on the fetus including the potential for harm.
• It applies only to the prescribed therapeutic doses. It does not apply to when the therapeutic dose has been exceeded, to overdose or when occupational exposure occurs.

AUSTRALIAN CATEGORISATION SYSTEM FOR PRESCRIBING MEDICINES IN PREGNANCY

• Category A

This category applies to drugs which have been taken by a large number of pregnant women without any proven increase in the frequency of malformations, or other direct or indirect harmful effects on the fetus.

• Category B1

This applies to drugs which have been taken by only a limited number of pregnant women without an increase in the frequency of malformation, or other direct or indirect harmful effects on the human fetus.

Studies in animals have not shown evidence of an increased occurrence of fetal damage.

• Category B2

Drugs which have been taken by only a limited number of pregnant women without an increase in the frequency of malformation or other direct or indirect harmful effects on the fetus.

Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of fetal damage.

• Category B3

Drugs which have been taken by only a limited number of pregnant women without an increase in the frequency of malformation or other direct or indirect harmful effects on the fetus having been observed.

However, studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

• Category C

Drugs which, owing to their pharmacological 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. Accompanying texts should be consulted for further details.

Category D

Drugs which have caused, are suspected to have caused, or may be expected to cause, an increased incidence of fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

Category X

Drugs which 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.

03 What Others Say

• Better Health Channel:  pregnancy and drugs fact sheet 

http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Pregnancy_and_drug

04 I Want To Know More

Other useful sites include:

• Perinatology.com drugs in pregnancy and breast feeding list references

http://www.perinatology.com/exposures/druglist.htm

• Mother Risk - Canadian website associated with hospital for sick kids, Toronto

http://www.motherisk.org/women/drugs.jsp

• DART data base US website linked to the national library of medicine that covers teratology and contains over 200,000 references. Searches can be by subject terms, title words or chemical name.

http://www.nlm.nih.gov/pubs/factsheets/dartfs.html

DART: Developmental Reproductive Toxicology Database

TOXNET Toxicology Data network

05 Clinicians Tools and Resources

• TGA:

 Prescribing medicines in pregnancy database

Last updated: 27/07/2011 by Dr Elizabeth Hallam*/Claire Galea

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