Taking Vedolizumab in Pregnancy Did Not Increase the Risk of Birth Defects or Adverse Pregnancy Outcomes

LA JOLLA, CA – Vedolizumab (sold under the trade name Entyvio®) is a medication that is used to treat Crohn’s disease and ulcerative colitis, which are two forms of inflammatory bowel disease (IBD). For women who became pregnant while taking vedolizumab, there are limited data on whether this medication could affect the pregnancy and the developing baby. Our study sought to examine this question by evaluating the safety/risk of vedolizumab use in pregnant women who were participating in MotherToBaby Pregnancy Studies.

What did we study? From 2015 to 2022, we enrolled 275 pregnant women in the United States and Canada; 99 of the women had IBD and reported taking vedolizumab sometime during their pregnancy, 76 women had IBD but were being treated with other biologic medications, and the remaining 100 women did not have IBD and were not exposed to vedolizumab or other biologic medications.

We interviewed the mothers up to three times during their pregnancy and once at the end of their pregnancies. We also collected information from the medical records of both mom and baby. Finally, a subset of the babies was examined by one of our study doctors. We then compared the three groups of women by looking at several pregnancy and birth outcomes, including pregnancy loss, preterm birth, and birth defects.

What did we find? We found no meaningful differences in the rates of pregnancy loss, preterm birth, or birth defects between the groups. There were also no meaningful differences between the groups on infant growth measures at birth and at 1 year of age.

What’s the takeaway? Taking vedolizumab in pregnancy did not increase the chance of birth defects or other adverse pregnancy outcomes. Our study provides additional reassuring evidence for women with IBD who take vedolizumab during pregnancy.

Reference:

Chambers CD, Johnson DL, Luo Y, Xu R, Adam MP, Braddock SR, Jones KL; OTIS Collaborative Research Group. Birth Outcomes in Women Who Have Taken Vedolizumab in Pregnancy: Results from the Vedolizumab Pregnancy Exposure Registry. Am J Gastroenterol. 2025 Jun 11. doi: 10.14309/ajg.0000000000003593. Epub ahead of print. PMID: 40498121.

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Media Contact: Nicole Chavez, 619-368-3259, nchavez@MotherToBaby.org.

 

 


Taking Vedolizumab in Pregnancy Did Not Increase the Risk of Birth Defects or Adverse Pregnancy Outcomes

As we enter the 2024-2025 respiratory virus season, MotherToBaby wants to highlight the importance of vaccinations during pregnancy. All pregnant people are recommended to receive the annual flu shot and an updated 2024-2025 COVID-19 vaccine. Tdap, and the Abrysvo® RSV vaccine are recommended in the third trimester. These vaccines are well studied in pregnancy and not expected to increase risks for the developing baby. Furthermore, by protecting the pregnant person from diseases like the flu, COVID-19, pertussis, and RSV, vaccinations can help reduce the risk of pregnancy complications and ensure babies are born with protection against serious illnesses.

MotherToBaby knows that people who are pregnant have a lot to remember. Between taking a prenatal vitamin every day, getting blood work done, attending prenatal visits, and preparing for baby’s arrival, the pregnancy to-do list can feel never-ending. In an effort to provide a simplified reminder about the four vaccines recommended in pregnancy and why they are each so important, MotherToBaby has created a helpful infographic available for download below.

“This infographic is a great reminder of the many benefits vaccinations offer during pregnancy” shared Kirstie Perrotta, MPH, co-chair of MotherToBaby’s Emerging Issues Task Force. “Getting these vaccines on time is one of the most important things a pregnant person can do for their health and the health of their baby.”

For a PDF version of the infographic, click here.

MotherToBaby also has other resources available on the topic of vaccination in pregnancy.

Be sure to subscribe to The MotherToBaby Podcast so you don’t miss our upcoming episode series on vaccination. The podcast is available on iTunes, Amazon Music or wherever you listen to podcasts. 

Past vaccine-related podcast episodes:

RSV Vaccine in Pregnancy

Vaccine Questions during Pregnancy Answered

Vaccine Questions during Breastfeeding Answered

COVID-19 Vaccine in Pregnancy

Read our recent Baby Blogs discussing vaccination here:

And check out our vaccine fact sheets here:

Still have more questions? MotherToBaby specialists are happy to assist you further. Please feel free to call, chat, text, or email for more information: https://mothertobaby.org/contact/


Taking Vedolizumab in Pregnancy Did Not Increase the Risk of Birth Defects or Adverse Pregnancy Outcomes

The National Maternal Mental Health Hotline Provides 24/7 Support Before, During, and After Pregnancy

BRENTWOOD, TN – MotherToBaby, a no-cost service of the non-profit Organization of Teratology Information Specialists (OTIS) that educates the public about exposures during pregnancy and breastfeeding, proudly announces a new partnership to further support maternal mental health with the National Maternal Mental Health Hotline (NMMHH).

NMMHH provides perinatal mental health support through their toll-free phone line, 1-833-TLC-MAMA (1-833-852-6262). The hotline was established in 2022 on Mother’s Day, during May’s Maternal Mental Health Awareness Month. Over the course of the first year of operation, the hotline reports that the top reasons people contacted its service included depression, anxiety, feeling overwhelmed, issues related to pregnancy, and relationship conflict. “From our vantage point, the data resonates as the day-to-day experiences individuals have before, during and after pregnancy,” explained Tiffany J. Williams, project director for NMMHH. “We know that early intervention, trauma-informed support, and resources/referrals establish individuals for continued success in their maternal mental health journeys – this is why it is imperative to prioritize seeking support and professional help,” she added.  

MotherToBaby has become the leader in birth defects research, and has been available to the public for more than 30 years. During that time, MotherToBaby specialists have answered questions from the public about medications, vaccines, beauty products, herbal supplements, workplace exposures and much more during pregnancy and breastfeeding via its helpline 866-626-6847, text line 855-999-3525, email and live chat on MotherToBaby.org.

MotherToBaby and NMMHH have partnered by establishing a bidirectional referral and warm transfer process specifically to address the growing demand for perinatal mental health support. “It’s a win-win for those we serve,” said Lorrie Harris-Sagaribay, MPH, a bilingual teratogen information specialist and the OTIS/MotherToBaby President-Elect. “Regardless of whether a person reaches out first to MotherToBaby about specific medications for mental health, or to NMMHH about emotional support for mental health, they can be assured of greater access to personalized information from highly trained experts from both services, free of charge.”

Both NMMHH and MotherToBaby services are available in English and in Spanish. To learn more about NMMHH, please visit https://mchb.hrsa.gov/national-maternal-mental-health-hotline.  To learn more about MotherToBaby and browse its library of fact sheets, blogs and podcasts, please visit www.MotherToBaby.org.

MotherToBaby is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $6,000,000 with zero percentage financed with non-governmental sources. The contents of this release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government. To learn more about MotherToBaby and OTIS, please visit www.MotherToBaby.org.  

Media Contact: Nicole Chavez, 619-368-3259, nchavez@mothertobaby.org


Taking Vedolizumab in Pregnancy Did Not Increase the Risk of Birth Defects or Adverse Pregnancy Outcomes

The Bilingual Website is the Latest Addition to the Non-Profit’s Toolkit to Promote Healthy Pregnancies and Reduce Birth Defects

BRENTWOOD, TN – ¿Hablas español? ¡Sí! In time for January’s Birth Defects Awareness Month, MotherToBaby is proud to announce the launch of its fully bilingual (English/Spanish) website. It’s the first of its kind for housing an extensive bilingual library of fact sheets on everything from alcohol to zolpidem during pregnancy and breastfeeding as well as connecting bilingual experts with parents and healthcare providers.

Only select portion of MotherToBaby’s resources were previously available in Spanish. The now fully bilingual website is designed to fill the gap in the disparities of health education information for pregnant and breastfeeding individuals who are Spanish-speakers. MotherToBaby wants to improve birth outcomes in the Latinx community by giving improved access to language-appropriate resources to families and health professionals.

“It’s our experience that all parents and parents-to-be want the best information possible in order to have a healthy baby,” said Lorrie Harris-Sagaribay, MPH, a bilingual teratogen information specialist and the MotherToBaby President-Elect. “No matter what the language they speak is, we want everyone to have access to the best, expert health information possible. Making our free resources available in the second most-used language in the U.S. will help us reach many who are currently underserved.”

MotherToBaby, a no-cost service of the international non-profit Organization of Teratology Information Specialists (OTIS), has been available to the public for more than 30 years. During that time, it has become the leader in birth defects research as well as answering questions the public has about exposures, like medications, vaccines, beauty products, herbal supplements, workplace exposures and much more, during pregnancy and breastfeeding. MotherToBaby is a suggested resource by many federal agencies including the Centers for Disease Control and Prevention (CDC).

The fully bilingual website comes on the heels of other Spanish resources previously available including more than 300 fact sheets, a phone information service (866-626-6847), texting line (855-999-3525), and live chat and email (available on MotherToBaby.org). Just some of the website updates include one-stop resource hubs organized by exposure topic and health field, a FREE online materials ordering system for patient education and materials, and fully translated information about the research arm of the organization, MotherToBaby Pregnancy Studies. Much of the information that the scientific community knows about medication and vaccine use during pregnancy comes from observational studies. With accessible information about study participation in Spanish, MotherToBaby is aiming to increase participant diversity and better reflect the community that may need to take these drugs to treat or prevent illness.

“The risk to the developing baby from certain exposures during a pregnancy can vary greatly depending on timing of the exposure and much more,” said Harris-Sagaribay. “To be able to provide information tailored to a pregnant person’s personal circumstance allows for better informed decision-making. I’m proud to be part of a service that empowers parents like that not only in English but also in Spanish.”

The Spanish-language website is just one of MotherToBaby’s latest effort in making health education information more accessible to people outside of native English speakers. MotherToBaby is exploring the expansion of its bilingual resources to make them available in more languages. For example, it recently made its COVID-19 mRNA Vaccines fact sheet available in Arabic, Chinese, Portuguese, Tagalog and Vietnamese.

Visit the new Spanish-language website at MotherToBaby.org/es. The MotherToBaby website is not intended to be a substitute for professional judgment. Users should consult personal healthcare providers for pregnancy and breastfeeding advice related to their particular situation.

More about OTIS and MotherToBaby

The Organization of Teratology Information Specialists (OTIS) is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies.

MotherToBaby is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $6,000,000 with zero percentage financed with non-governmental sources. The contents of this release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS or the U.S. Government. To learn more about MotherToBaby and OTIS, please visit www.MotherToBaby.org.  

Media Contact: Nicole Chavez, 619-368-3259, nchavez@mothertobaby.org


Taking Vedolizumab in Pregnancy Did Not Increase the Risk of Birth Defects or Adverse Pregnancy Outcomes

MotherToBaby is the Leading National Resource on Exposures during Pregnancy and Breastfeeding

BRENTWOOD, TN – The non-profit Organization of Teratology Information Specialists (OTIS), which provides the MotherToBaby free service, receives new funding aimed at enhancing partnerships to address birth defects, infant disorders and related conditions, and the health of pregnant and postpartum people. The grant is supported by the Centers for Disease Control and Prevention (CDC).

The funding is a five-year award beginning October 1, 2023. “This remarkable funding is a testament to our tireless dedication to staying ahead of the curve when it comes to diseases, infections, and empowering the public with the latest information,” said Alfred Romeo, RN, PhD, President of MotherToBaby. “We are thrilled to collaborate with numerous organizations to amplify the impact of our vital work,” he added.

Great strides will be made under this grant, including collecting and disseminating data, developing and distributing data-driven resources, forging valuable partnerships, and fostering community engagement to raise awareness of the invaluable services provided by MotherToBaby.

“This support is a game-changer, enabling us to further equip pregnant and breastfeeding individuals with crucial information, especially during health crises like the recent COVID-19 pandemic,” Romeo emphasized. “The partnerships we build will help us navigate the next emerging issue affecting people who are pregnant and breastfeeding.”

MotherToBaby provides information on exposures, like medications, vaccines, diseases, herbal supplements, occupational exposures and more before and during a pregnancy as well as while breastfeeding. The service is provided through its no-cost helpline 866-626-6847, texting service 855-999-3525 and website www.MotherToBaby.org, where the public can live chat, e-mail an expert or browse a library of fact sheets in English and Spanish. Additionally, MotherToBaby hosts LactRx, a free app providing current information on the use of medications, vaccines, diagnostic agents, and drugs of misuse during breastfeeding. LactRx is available for iPhone and Android.

More about OTIS and MotherToBaby

The Organization of Teratology Information Specialists (OTIS) is a professional scientific society made up of individuals engaged in assessing and evaluating risks to pregnancy and breastfeeding from environmental exposures. Members include, but are not limited to, specialists in the fields of obstetrics and gynecology, pediatrics, genetics, dysmorphology, perinatal epidemiology, teratology, behavioral teratology, pharmacy, genetic counseling, nursing, midwifery, maternal and child health, public health, and includes experts that provide MotherToBaby services and researchers that conduct MotherToBaby Pregnancy Studies. To learn more about MotherToBaby and OTIS, please visit www.MotherToBaby.org

Media Contact: Nicole Chavez, 619-368-3259, nchavez@mothertobaby.org