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©2014 Baishideng Publishing Group Inc.
World J Gastroenterol. Jul 21, 2014; 20(27): 8790-8795
Published online Jul 21, 2014. doi: 10.3748/wjg.v20.i27.8790
Published online Jul 21, 2014. doi: 10.3748/wjg.v20.i27.8790
Table 1 Food and Drug Administration drug administration categories for the use of medications in pregnancy
Category | Observations |
A | Controlled studies both in humans and in animals have shown that there is no risk during the first trimester and the possibility of fetal harm is remote |
B | Studies in animals have shown no risk to the fetus. However, no controlled studies have been carried out in pregnant women. In addition, studies in animals have revealed adverse effects which were not confirmed in pregnant women in the first trimester |
C | There is no record of controlled studies in humans. Studies in animals have shown adverse effects. Moreover, studies in humans and animals showing that the benefit may outweigh the risk have not been validated |
D | Evidence of risk for the fetus |
X | Studies in animals and humans have shown fetal abnormalities, so these drugs are contraindicated |
Table 2 Safety of medications prescribed for inflammatory bowel disease during pregnancy
Safe to use when indicated | Limited data but used when clinically indicated | Contraindicated |
Mesalamine | Olsalazine | Methotrexate |
Sulfasalazine | AZA/6 MP | Thalidomide |
Balsalazide | Ciprofloxacin | |
Corticosteroids | Metronidazole | |
TPN | Biologics | |
Loperamide | Cyclosporine |
Table 3 Classification of the drugs concerning the fetal risk according to Food and Drug Administration
Drugs | Recommendation |
Adalimumab | Pregnancy (low risk) |
Category B | Breastfeeding (probably compatible) |
Azathioprine/6-mercaptopurina | Pregnancy (low risk) when used in low doses and as mono-therapy |
Category D | Breastfeeding (it is recommended to breastfeed 4 h after taking the drug) |
Balsalazide | Pregnancy (low risk) |
Category B | Breastfeeding (probably compatible) |
Certolizumab | Pregnancy (low risk) |
Category B | Breastfeeding ( probably compatible) |
Ciprofloxacin | Pregnancy (not recommended due to skeletal muscular dysfunction) |
Category C | Breastfeeding (compatible) |
Corticosteroids | Pregnancy (risk of adrenal insufficiency, premature rupture of membrane, in the first trimester although there is little risk of cleft palate) |
Category C | Breastfeeding (probably compatible) |
Cyclosporine | Pregnancy (no congenital abnormalities have been noticed) |
Category C | Breastfeeding (contraindicated) |
Infliximab | Gestation (low risk when administered as mono-therapy) (increased risk of infection when used in combination with azathioprine) |
Category B | Breastfeeding (probably compatible) |
Mezalazine | Pregnancy (asacol showed low risk of teratogenicity in animal models) |
Category B | Breastfeeding (both probably compatible) |
Asacol (category C) | |
Methotrexate | Contraindicated in both conditions |
Category X | |
Metronidazole | Pregnancy (used in the first trimester increases the risk of cleft palate) |
Category B | Breastfeeding (toxic) |
Olsalazine category (C) | Pregnancy (limited risk) |
Breastfeeding (probably compatible) | |
Rifaximin | Pregnancy (animal studies show teratogenicity) |
Category C | Lactation (its safety is unknown) |
Sulfasalazine | Pregnancy (low risk if administered in conjunction with folic acid) |
Category B | Breastfeeding (probably compatible) |
Tacrolimus | Pregnancy (no increased risk described) |
Category C | Breastfeeding (contraindicated) |
Thalidomide | Contraindicated in both conditions |
Category X |
- Citation: Cury DB, Moss AC. Treatment of Crohn’s disease in pregnant women: Drug and multidisciplinary approaches. World J Gastroenterol 2014; 20(27): 8790-8795
- URL: https://www.wjgnet.com/1007-9327/full/v20/i27/8790.htm
- DOI: https://dx.doi.org/10.3748/wjg.v20.i27.8790