Treatment of pregnant women with a diagnosis of inflammatory bowel disease

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

FDA: Food and Drug Administration.

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

¹Asacol HD (due to the dibutyl phthalate content) and olsalazine are category C drugs. FDA: Food and Drug Administration.