Treatment of Crohn’s disease in pregnant women: Drug and multidisciplinary approaches

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

TPN: Total parenteral nutrition; AZA: Azathioprine MP: Mercaptopurine.

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