FDA PREGNANCY RISK
CATEGORIES
Prior to 2015
After 2015
Category A: adequate and well-controlled studies have failed to demonstrate
a risk to the fetus. Okay to use. Examples include levothyroxine, folic acid,
liothyronine.
Category B: animal studies have failed to demonstrate a risk to the fetus but
there are good studies in pregnant women. Okay to use. Examples include
metformin, hydrochlorothiazide, cyclobenzaprine, amoxicillin, pantoprazole.
Category C: animal studies have shown an adverse effect on the animal
fetus; there are no good studies in humans but potential benefits may warrant
use of the drug in pregnant women. May use. Examples include tramadol,
gabapentin, amlodipine, trazodone.
Category D: human studies have shown an adverse effect on human fetus
but potential benefits may warrant use of the drug in pregnant women. May
use. Examples include lisinopril, alprazolam, losartan, clonazepam,
lorazepam.
Category X: human studies have shown an adverse effect on human fetus
and risks clearly outweigh benefits in pregnant women. Do not
use. Examples include atorvastatin, simvastatin, warfarin, methotrexate,
finasteride.