Pregnancy related issues in inflammatory bowel disease: Evidence base and patients' perspective

Table 1 Food and Drug Administration categories of drug safety during pregnancy

FDA category	Definition
A	Controlled studies in animals and women have shown no risk in the first trimester, and possible foetal harm is remote
B	Either animal studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women, or animal studies have shown an adverse effect that was not confirmed in controlled studies in women in the first trimester
C	No controlled studies in humans have been performed, and animal studies have shown adverse events, or studies in humans and animals not available; give if potential benefit outweighs the risk
D	Positive evidence of foetal risk is available, but the benefits may outweigh the risk if life-threatening or serious disease
X	Studies in animals or humans show foetal abnormalities; drug contraindicated

FDA: Food and Drug Administration.

Table 2 Medication recommendation for pregnancy and breast feeding

Class	Drugs	FDA category	Pregnancy advice	Detection in breast milk
Aminosalicylates	Sulfasalazine, balsalazide, mesalazine	B	Safe to use (folate supplementation for sulfasalazine)	Low levels detectable
Aminosalicylates	Olsalazine	C	Safe to use
Antibiotics	Metronidazole	B	Safe to use
Antibiotics	Ciprofloxacin		Limited data; probably safe
Corticosteroids	Prednisolone, budesonide	C	Safe to use	Detectable
Thiopurines	Azathioprine, 6-mercaptopurine	D	Safe to use	Very low levels detectable
Folate antagonist	Methotrexate	X	Absolutely contraindicated
Biological agent	Infliximab	B	Probably safe (avoid during 3rd trimester)	Not detectable
Biological agent	Adalimumab	B	Probably safe (avoid during 3rd trimester)	Very low levels detectable

FDA: Food and Drug Administration.