Complications of Pregnancy and Child Development After Cessation of Treatment With 6-Mercaptopurine for Inflammatory Bowel Disease

Zlatanic, Jusuf; Korelitz, Burton I.; Rajapakse, Ramona; Kim, Peter; Rubin, Steven D.; Baiocco, Peter J.; Panagopoulos, Georgia

doi:10.1097/00004836-200304000-00005

Cited by 36 publications

(9 citation statements)

References 35 publications

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“…In IBD, multiple case series have not noted an increase in congenital anomalies [97][98][99][100], although one study did report a higher incidence of fetal loss in women with IBD with prior treatment on 6MP compared with those who had never had 6MP exposure [101]. A French study of 86 women with IBD exposed to thiopurines during pregnancy versus 129 who were unexposed did not find a difference in the rate of congenital anomalies [102].…”

Section: Methotrexatementioning

confidence: 99%

Inflammatory bowel disease and pregnancy: an update

Kwan

2010

Expert Review of Clinical Immunology

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Women with inflammatory bowel disease have similar rates of conception to the general population unless they have had pelvic surgery. Once pregnant, regardless of disease activity, they have an increased risk of adverse pregnancy outcome and should be followed as high-risk obstetric patients. Most medications are compatible with pregnancy and lactation, as described in this article. Ideally, women should discuss their plans for pregnancy with their physician prior to conception so that risks and benefits can be reviewed, medications adjusted and healthcare maintenance updated. Once pregnant, a multidisciplinary team of gastroenterologists, obstetricians and pediatricians should help to ensure the best care for the mother and child.

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Section: Methotrexatementioning

confidence: 99%

Inflammatory bowel disease and pregnancy: an update

Kwan

2010

Expert Review of Clinical Immunology

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“…Indeed, a recent study suggests that the discontinuation of mercaptopurine before conception may actually increase the chance of fetal loss. 63 It has been advised in the past to decrease the dose of azathioprine, with the hypothetical objective of reduce the probability of fetal adverse effects. However, a reduced incidence of complications due to this dose reduction has never been demonstrated.…”

Section: Azathioprine/mercaptopurinementioning

confidence: 99%

Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding

Gisbert

2010

Inflammatory Bowel Diseases

124

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The aim of this article is to critically review available data regarding the safety of immunomodulators and biological therapies during pregnancy and breast-feeding in women with inflammatory bowel disease. Methotrexate and thalidomide can cause congenital anomalies and are contraindicated during pregnancy (and breast-feeding). Although thiopurines have a Food and Drug Administration (FDA) rating D, available data suggest that these drugs are safe and well tolerated during pregnancy. Although traditionally women receiving azathioprine or mercaptopurine have been discouraged from breast-feeding because of theoretical potential risks, it seems that these drugs may be safe in this scenario. Treatment with cyclosporine for steroid-refractory ulcerative colitis (UC) during pregnancy can be considered safe and effective, and the use of this drug should be considered in cases of severe UC as a means of avoiding urgent surgery. Breast-feeding is contraindicated for patients receiving cyclosporine. Biological therapies appear to be safe in pregnancy, as no increased risk of malformations has been demonstrated. Therefore, the limited clinical results available suggest that the benefits of infliximab and adalimumab in attaining response and maintaining remission in pregnant patients might outweigh the theoretical risks of drug exposure to the fetus. Stopping therapy in the third trimester may be considered, as it seems that transplacental transfer of infliximab is low prior to this. Certolizumab differs from infliximab and adalimumab in that it is a Fab fragment of an antitumor necrosis factor alpha monoclonal antibody, and therefore it may not be necessary to stop certolizumab in the third trimester. The use of infliximab is probably compatible with breast-feeding.

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“…There is evidence to suggest that discontinuation of the medications needed to maintain remission at any stage of pregnancy may lead to reactivation of disease which may carry with it an increased risk for an adverse pregnancy outcome (102). Thus, as the dictum “healthy mother, healthy baby” appears to apply to women with IBD, we generally agree with continuation of medication prior to and during pregnancy.…”

Section: Expert Commentarymentioning

confidence: 99%

Safety and efficacy of immunomodulators and biologics during pregnancy and lactation for the treatment of inflammatory bowel disease

Saha

Wald

2012

Expert Opinion on Drug Safety

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Introduction The inflammatory bowel diseases (IBD) are chronic, idiopathic, inflammatory conditions of the gastrointestinal tract that peak in incidence during the reproductive years. Therefore, the safety of IBD medications during pregnancy and lactation is of significant interest to many patients. Unfortunately, the current pregnancy labeling used by the United States Food and Drug Association (FDA) is often misinterpreted and may mislead healthcare providers and their patients to believe that risk increases from category A to B to C to D to X which, in fact, is not the case. In addition, the FDA categories do not always distinguish between risks based on human versus animal data or between differences in frequency, severity, and type of fetal developmental toxicities. Thus, providers should not rely solely on the FDA category labels when making medication choices in pregnant and lactating women and should instead be familiar with the primary safety data for the medications they prescribe. Areas Covered This article will discuss general safety data and safety classifications for medication use in pregnancy. It will also provide an in-depth review of the available safety data during pregnancy and lactation for the more potent immunosuppressants used to treat IBD: the immunomodulators and biologics. Lastly, it will include the authors’ expert opinions on the use of these medications during these critical periods. Expert Opinion The benefit-to-risk ratio for most immunomodulators and biologics used in the treatment of IBD favors medication continuation during pregnancy. Certain immunomodulators, however, can cause extreme fetal harm and should be used with caution in all individuals of reproductive potential. While human safety data regarding teratogenesis and some data on pregnancy outcomes exist for most IBD medications, long-term follow-up studies of children and young adults exposed to these drugs in utero are lacking. These studies are needed to determine if these drugs are of sufficiently low risk to be considered safe.

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Complications of Pregnancy and Child Development After Cessation of Treatment With 6-Mercaptopurine for Inflammatory Bowel Disease

Cited by 36 publications

References 35 publications

Inflammatory bowel disease and pregnancy: an update

Inflammatory bowel disease and pregnancy: an update

Safety of immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding

Safety and efficacy of immunomodulators and biologics during pregnancy and lactation for the treatment of inflammatory bowel disease

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