Antepartum: FDA Pregnancy Categories Flashcards
Category A
Fetus
(FDA)
Category A
Adequate and well-controlled 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).
Example drugs or substances: levothyroxine, folic acid, magnesium sulfate, liothyronine
Category B
Animal
Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Example drugs: metformin, hydrochlorothiazide, cyclobenzaprine, amoxicillin, pantoprazole
Category C
Animal
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.
Example drugs: tramadol, gabapentin, amlodipine, trazodone, prednisone
Category D
Fetus
Category D
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.
Example drugs: lisinopril, alprazolam, losartan, clonazepam, lorazepam
Category X
Animal or Human
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.
Example drugs: atorvastatin, simvastatin, warfarin, methotrexate, finasteride
Category N
Category N
FDA has not classified the drug.
Example drugs: aspirin, oxycodone, hydroxyzine, acetaminophen, diazepam
