| [ Summary ] |
The United States Food and Drug Administration (FDA) has placed AZA/6-MP in risk category D. It appears that there is valid reason for physicians to be aware that treatment with AZA/6-MP during pregnancy may increase the risks of preterm birth, still birth, low birth weight and congenital abnormalities. Accordingly, all patients with IBD, either female or male who are considering conception should be adequately counseled regarding the risks of drug therapies during pregnancy, and be advised to become pregnant while in clinical remission. Further, women receiving AZA/6-MP should be discouraged from breast feeding due to the likelihood of drug transfer into milk (albeit recent reports that it may be safe). |