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level: FDA PREGNANCY RISK CATEGORY

Questions and Answers List

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