Around the world we have labelling requirements for both practitioners and patients so 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.

 


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