Review
Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Nov 7, 2014; 20(41): 15241-15252
Published online Nov 7, 2014. doi: 10.3748/wjg.v20.i41.15241
Table 2 United States food and drug administration categorization of drug safety during pregnancy1
CategoryRiskDescription
ANo risk has been shown in controlled studiesSufficient, well-controlled studies have not demonstrated a risk to the fetus in any trimester of pregnancy
BNo risk in humansSufficient, well-controlled studies have not demonstrated an increased risk of fetal abnormalities despite adverse findings in animals or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is very low but still is a possibility
CRisk cannot be ruled outSufficient, no well-controlled human studies, where animal studies have shown a risk to the fetus. There is a chance of fetal harm if the drug is administered during pregnancy, but the potential benefits should be considered and may outweigh the potential risk
DPositive evidence of riskStudies in humans, or investigational or postmarketing data, have demonstrated fetal risk. Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or for serious disease for which safer drugs cannot be used or are ineffective
XContraindicated in pregnancyStudies in animals or humans (investigational or postmarketing reports) have demonstrated positive evidence of fetal abnormalities or risk that clearly outweighs any possible benefit to the patient