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©The Author(s) 2016.
World J Gastrointest Pharmacol Ther. Nov 6, 2016; 7(4): 490-502
Published online Nov 6, 2016. doi: 10.4292/wjgpt.v7.i4.490
Published online Nov 6, 2016. doi: 10.4292/wjgpt.v7.i4.490
Table 1 Food and Drug Administration pregnancy categories
FDA category | Definition |
A | Controlled studies in animals and women demonstrate no risks during the first trimester, and the possibility of fetal harm appears remote |
B | Studies in animals have not demonstrated a fetal risk, but no controlled studies have been conducted in pregnant women, or animal studies have shown an adverse event that was not confirmed in controlled studies in women during the first trimester. Chance of fetal harm is remote but remains a possibility |
C | No controlled studies have been conducted in women, and animal studies have shown adverse effects on the fetus, or studies in humans and animals are not available. Chance of fetal harm. Give only if potential benefit outweighs the risk |
D | There are no controlled studies in women or animals, but positive evidence of fetal risk is available. It can still be used for life-threatening or serious diseases when there are no effective alternative drugs |
X | Studies in animals or women have demonstrated fetal abnormalities. The drug is contraindicated in women who are pregnant or may become pregnant |
Table 2 Safety of inflammatory bowel disease medications during pregnancy and breastfeeding
Medication | FDA category | Comments during pregnancy | Comments during breastfeeding |
Adalimumab | B | Low risk: Transported through the placenta late in the second and third trimester; avoid treatment in the last trimester | Compatible |
5-Aminosalicylic acid preparations1 | B | Low risk: Limited data for olsalazine; if using sulfasalazine, folic acid supplementation is mandatory | Enters breast milk; probably compatible |
Amoxicillin/clavulanate | B | Low risk | Enters breast milk; probably compatible |
Azathioprine/6-mercaptopurine | D | Low risk | Low transfer to infant; appears in the milk 4 h after ingestion |
Budesonide/prednisone | C | Probably low risk, avoid during first trimester (potential risk of oral clefts) | Probably compatible; enters breast milk |
Certolizumab | B | Low risk | Limited data; probably compatible |
Ciprofloxacin | C | Limited data; not recommended | Compatible |
Cyclosporine | C | Low risk | Contraindicated |
Methotrexate | X | Contraindicated: Teratogenic | Contraindicated |
Metronidazole | B | Low risk, avoid during the first trimester | Enters breast milk, not recommended |
Natalizumab | C | Limited data; low risk | Limited data; probably compatible |
Tacrolimus | C | Limited data; no increase in congenital anomalies | Contraindicated |
Thalidomide | X | Contraindicated: Teratogenic | No data available; potential toxicity |
- Citation: Poturoglu S, Ormeci AC, Duman AE. Treatment of pregnant women with a diagnosis of inflammatory bowel disease. World J Gastrointest Pharmacol Ther 2016; 7(4): 490-502
- URL: https://www.wjgnet.com/2150-5349/full/v7/i4/490.htm
- DOI: https://dx.doi.org/10.4292/wjgpt.v7.i4.490