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Copyright ©2012 Baishideng Publishing Group Co.
World J Gastroenterol. Jun 7, 2012; 18(21): 2600-2608
Published online Jun 7, 2012. doi: 10.3748/wjg.v18.i21.2600
Table 1 Food and Drug Administration categories of drug safety during pregnancy
FDA categoryDefinition
AControlled studies in animals and women have shown no risk in the first trimester, and possible foetal harm is remote
BEither animal studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women, or animal studies have shown an adverse effect that was not confirmed in controlled studies in women in the first trimester
CNo controlled studies in humans have been performed, and animal studies have shown adverse events, or studies in humans and animals not available; give if potential benefit outweighs the risk
DPositive evidence of foetal risk is available, but the benefits may outweigh the risk if life-threatening or serious disease
XStudies in animals or humans show foetal abnormalities; drug contraindicated