Studies on Entyvio and pregnancy have not been done with humans. Studies on monkeys and rabbits, however, showed no evidence of harm to fetuses. These studies involved injecting animals with doses that were 20 times higher than the recommended dosage levels for humans. According to the FDA, Entyvio (vedolizumab) should only be used during pregnancy if the benefits of receiving these injections outweighs the risks to the fetus.
Entyvio and Breastfeeding
Vedolizumab can be found in human breast milk . Clinical trials show that vedolizumab was found in milk produced by lactating monkeys aswell as in humans. Women who are breastfeeding should discuss the safety of receiving vedolizumab injections with their healthcare provider.
Is vedolizumab safe in pregnancy?
Vedolizumab should only be used with caution during pregnancy, since potential risks to developing fetuses are unknown. Adverse effects during pregnancy may be greater in the second and third trimester, since larger amounts of monoclonal antibodies cross the placenta during this time. Women who are considering receiving vedolizumab injections should discuss potential risks with their healthcare provider.
Can Crohn’s disease cause birth defects?
Crohn’s disease itself may be associated with an increased risk of birth defects. A 2020 study found that Crohn’s disease and ulcerative colitis were associated with an increased risk of certain types of birth defects, such as central nervous system defects and abdominal wall defects. Additionally, certain types of medications used to treat Crohn’s disease, such as methotrexate and thalidomide, have been associated with a higher risk of birth defects, as well as fetal deaths.
Can you carry a baby with Crohn’s disease?
Women who have Crohn’s disease might have a more difficult time getting pregnant. During pregnancy, some women experience fewer symptoms of this disease due to changes that occur in the body at this time. In fact, a 2016 study found that symptom improvement occurs in roughly 33 to 74 percent of women who have active Crohn’s disease during conception.
However, active Crohn’s disease is also associated with a higher risk of miscarriage or premature deliveries and stillbirths. These risks are slightly higher in women with inactive Crohn’s disease compared to pregnant women without Crohn’s disease. Pregnant women should discuss treatment options for active Crohn’s disease with their medical provider in order to ensure safety and lower the risk of a miscarriage or a premature delivery and stillbirth.
Is Entyvio safe for pregnancy?
No research studies on the use of Entyvio in pregnant women have been done, so the potential risks and adverse effects are not known. However, we do know that it does cross the placenta and the information/ data collection is continuing. Animal studies involving rabbits and monkeys showed no harmful or adverse effects to fetuses or impaired fertility when these animals received injections that were 20 times higher than the recommended dosages for humans. However, the results of animal reproduction studies do not always accurately predict results for humans.