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Index
»
PHARMCARE 3
»
ADVERSE DRUG REACTION.pptx
»
FDA PREGNANCY RISK CATEGORY
level: FDA PREGNANCY RISK CATEGORY
Questions and Answers List
level questions: FDA PREGNANCY RISK CATEGORY
Question
Answer
NOT SHOWN INCREASED RISK OF FETAL ABNORMALITIES
CATEGORY A
ANIMAL STUDIES SHOWED NO EVIDENCE OF HARM TO THE FETUS; HOWEVER, NO ADEQUATE AND WELL CONTROLLED STUDIES IN PREGNANT WOMEN. OR ANIMAL STUDIES SHOWN ADVERSE EFFECT BUT IN WOMEN, HAVE FAILED TO DEMONSTRATE A RISK TO FETUS
CATEGORY B
ANIMAL STUDIES SHOWN ADVERSE EFFECTS BUT NO ADEQUATE OR CONTROLLED STUDIES FOR PREGNANT WOMEN. OR NO ANIMAL STUDIES HAVE BEEN CONDUCTED AND THERE ARE NO ADEQUATE AND WELL CONTROLLED STUDIES IN PREGNANT WOMEN
CATEGORY C
ADEQUATE AND WELL CONTROLLED STUDIES IN PREGNANT WOMEN HAVE DEMONSTRATED A RISK TO THE FETUS. HOWEVER, THE BENEFITS OF THERAPY MAY OUTWEIGH POTENTIAL RISKS
CATEGORY D
ADEQUATE AND WELL CONTROLLED STUDIES IN ANIMALS & PREGNANT WOMEN HAVE DEMONSTRATED A POSITIVE EVIDENCE OF FETAL ABNORMALITIES. CONTRAINDICATED IN WOMEN WHO ARE PREGNANT OR MAY BECOME PREGNANT
CATEGORY X
A US FDA PREGNANCY RATING IS NOT AVAILABLE
Category NA