Pregnancy studies Flashcards
Category A: (A is an adaquate trimester)
Category A: Adequate & well-controlled studies have
failed to determine a Risk to Fetus in 1st Trimester of Pregnancy & No
evidence of Risk in later trimesters
Category B (B the animal)
Category B: Animal reproductive studies failed to
determine Risk to Fetus & there are no adequate & well controlled
studies in pregnant women
Category C (C, only adverse effects in animals)
Animal reproductive studies shown an
adverse effect on Fetus& there are no adequate & well controlled
studies in humans, but potential Benefits may warrant drug use in
pregnant women despite potential Risks.
Category D (Dee marketing)
Positive evidence of human fetal Risk based on adverse reaction data from investigational, marketing experience
or studies in humans, but potential benefits may warrant use of drug
in pregnant women despite Risks
Category X (X out humans and animals)
Studies in animals or humans demonstrated
fetal abnormalities w/ positive evidence of human fetal Risk based on
adverse reaction to use of drug in pregnant women clearly outweighs
potential benefit
