Copyright
©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
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 |
- 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