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Pregnancy (Drug) Categories in the US -Breakdown

By Bound2Bearth Doulas

****Italic font provides simplified understanding of the medical definition.



What are Pregnancy Categories ?

ABCDXN


Category A) pregnancy drugs by definition- Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).


Basically... this means when the drug was tested on humans and didn't cause and risk to the baby in gestation at the time or later in the pregnancy.


Category B) by definition- Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.


Basically...category B) pregnancy drugs are thoroughly tested on animals and have no result of causing risk to harm to their fetus. At the same time, there is not a wide range of human-mother testing with category B) pregnancy drugs to make a comparison.


Category C) Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.


Basically... These drugs are tested on animals and can potentially be dangerous to the fetus but can provide great pharmaceutical help to the birthing mother even though their fetuses could be affected.


Category D) pregnancy drugs -There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.


SO....This is almost like the category D) pregnancy drug your just read about. The only difference between these two categories is that categories is that, category D) is that they ARE tested on human women. They present the potential to harm the fetus but can often tremendously help the mother.


Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits



Basically... these drugs are tested on both humans and animals and definitely show that they will cause risk to the fetus In most cases these types of drugs are complete "last resorts" since the are harmful to the birthing mother as well.


Category N)

FDA has not yet classified the drug into a specified pregnancy category.


So... This category of pregnancy drugs have not been put into any of the categories above for various reasons. Those reasons could be that they are new on the market and/or the drug is still under close observation to understand the effects of the drug on the mother and fetus.



NOTE: In other countries, these categories for pregnancy drugs WILL vary. A category A) Drug in Australia is a polar opposite from a category A) drug in the US for pregnancy.







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