Global Pregnancy Drug Safety Categories Explained

Pregnancy risk categories vary around the world. This affects labelling requirements for both practitioners and patients so that pregnant or breastfeeding women are properly informed about drugs they are taking.

USA Pregnancy Risk Categories

Category A – Good studies have not found a risk to the foetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.
Category B – Animal studies have not found a risk to the foetus, but there are no studies that show whether the drug is safe in pregnant women.
Category C – Animal studies have shown an adverse effect on the foetus, but there are not good studies in humans. Potential benefits may outweigh risks in pregnant women.
Category D – There is evidence of risk to human foetuses based on experience or studies, but potential benefits of the drug may outweigh risks in pregnant women.
Category X – Studies have demonstrated foetal abnormalities and/or there is evidence of human foetal risk. The risks outweigh any potential benefits. Do not use in pregnancy!

Australian Pregnancy Risk Categories

Category A – No harmful effects on foetuses observed.
Category B1 – No increase in malformations or harm on human foetuses observed in limited number of women. Animal studies have not found any increased risk.
Category B2 – No increase in malformations or harm on human foetuses observed in limited number of women. Animal studies lacking or inadequate, but no sign of risks so far.
Category B3 – No increase in malformations or harm on human foetuses observed in limited number of women. Animal studies have shown evidence of increased damage in foetuses.
Category C – Drugs are suspected of causing harmful effects on human foetuses or newborns without causing malformations, with effects possibly reversible.
Category D – Drugs cause or are believed to cause or can be expected to cause an increased incidence of human foetal abnormalities or irreversible damage. Adverse effects.
Category X – Drugs have a high risk of causing permanent damage to the foetus and should not be used in pregnancy or when there is a risk of pregnancy.

Germany Pregnancy Risk Categories

Group 1 – Extensive studies on humans and animals have not shown the drug to be toxic to embryotoxic/teratogenic.
Group 2 – Extensive studies on humans have not shown the drug to be toxic to embryotoxic/teratogenic.
Group 3 – Extensive studies on humans have not shown the drug to be toxic to embryotoxic/teratogenic, but animal studies indicate it is embryotoxic/teratogenic.
Group 4 – No good studies are available on humans, but animal studies have not shown embryotoxic/teratogenic effects.
Group 5 – No good studies are available on humans.
Group 6 – No good studies are available on humans, but animal studies show embryotoxic/teratogenic effects.
Group 7 – The drug may have a embryotoxic/teratogenic effect in humans, possibly just in the first trimester.
Group 8 – The drug may have a embryotoxic/teratogenic effect in humans, into the second and third trimesters.
Group 9 – The drug may cause prenatal complications or abnormalities.
Group 10 – The drug may cause hormone-specific action in the human foetus.
Group 11 – The drug is known as a mutagen/carcinogen.