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Copyright ©2008 The WJG Press and Baishideng.
World J Gastroenterol. Mar 7, 2008; 14(9): 1326-1332
Published online Mar 7, 2008. doi: 10.3748/wjg.14.1326
Table 1 Food and drug administration (FDA) classes in pregnancy
ClassDefinition
AControlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of risk in later trimesters) and the possibility of fetal harm appears remote
BEither animal reproduction studies have not demonstrated a fetal risk, but there are no controlled studies in pregnant women OR animal reproduction studies have shown an adverse effect (other than decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of risk in later trimesters)
CEither studies in animals have repeated adverse effects on the fetus (teratogenic, embryonic or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus
DThere is positive evidence of human fetal risk but the benefits from use in pregnant women may be acceptable despite the risk (e.g. if the drug is needed in a life threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective)
XStudies in animals or human beings have demonstrated fetal abnormalities OR there is evidence of fetal risk based on human experience OR both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant
Table 2 FDA classes of medications used to treat IBD
FDA classMedications
B5-Aminosalicylic acid preparations (sulfasalazine, mesalamine, balsalazide); metronidazole, amoxicillin/clavulanic acid; infliximab; adalimumab
C5-Aminosalicylic acid preparations (Olsalazine); fluoroquinolones; corticosteroids; bisphosphonates; cyclosporin; tacrolimus
DAzathioprine and 6-MP
XMethotrexate; thalidomide
Table 3 Breastfeeding safety of medications used to treat IBD
SafeLimited data, potential toxicityContraindicated
Metronidazole
5-ASA preparationsFluoroquinolonesThalidomide
(sulfasalazine, mesalamine)BisphosphonatesMethotrexate
Amoxicillin/clavulanic acidAzathioprineCyclosporine (CsA)
Corticosteroids6-mercaptopurine (6-MP)Tacrolimus (FK506)
Adalimumab
Infliximab