Vedolizumab in Breastfeeding Mothers

Takeda Pharmaceuticals, USA is recruiting patients for an important research study. This is a “Multicenter and Open Enrollment model, Postmarketing Study to Evaluate the Concentration of vedolizumab in the Breast Milk of Mothers receiving Treatment with Vedolizumab”. Vedolizumab, also known as Entyvio®, is a prescription medication for the treatment of adults with moderate to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Its use in this study is investigational. Takeda would like to recruit mothers for this study, who in conjunction with their doctor, have already made the decision to use vedolizumab prior to taking part in this research study to determine just how much of this product enters the mother’s milk.

Participate in the study

Help us help other mothers by providing a milk sample.

  • Vortioxetine                            (Trintellix)
  • Sitagliptin                                (Januvia)
  • Dicloxacillin                            (Diclocil, Dynapen)
  • Lisinopril                                (Carace, Lisoril, Prinil, Zestril)
  • Warfarin                                  (Coumadin, Marevan)
  • Rivaroxiban                             (Xarelto)
  • Apixaban                                 (Eliquis)
  • Varneclin                                 (Chantix)
  • Cyclobenzaprine                     (Flexeril, Cycoflex)
  • Saxagliptin                               (Onglyza)

My research team is looking for breastfeeding mothers taking these medications.

If you would like to provide some breastmilk samples for one of these studies it would certainly help us advise other mothers about their safety and levels in breastmilk.

We’ll ship you a shipping carton with instructions, and milk containers.  Send it back to us frozen, at our expense.

Email us a telephone number or address and we’ll ship the collection packet.

Tom Hale R.Ph., Ph.D.

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Supporting Mothers and Health Care Providers

Each year, more than 4.3 million women give birth in the U.S. Virtually all of these women will use at least one medication during pregnancy or during breastfeeding.

The InfantRisk Center is dedicated to providing up-to-date evidence-based information on the use of medications during pregnancy and breastfeeding. By educating both the public and health care professionals regarding the risks of exposure to specific medications for mothers and babies, the center aims to reduce the number of birth defects and dangerous exposures in breastfeeding as well as create healthy breastfeeding relationships.

The InfantRisk Center provides resources such as the hotline, MommyMeds mobile app for consumers, InfantRisk Center mobile app for health care professionals and to make accessing safety information simple. The MommyMeds app and website are meant to provide information backed by Hale’s extensive research in an easy-to-read, concise format—perfect for the average mom facing difficult questions about medication use.

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About the InfantRisk Center Team

Dr. Thomas Hale

Thomas Hale, Ph.D., R.Ph., is a professor of pediatrics and associate dean of research at Texas Tech University Health Sciences Center and acting executive director of the InfantRisk Center.

Hale is considered one of the foremost expert in the field of perinatal pharmacology and the use of medications by pregnant and breastfeeding mothers.

The vision of the InfantRisk Center is to create a new body of drug information concerning the safety of medications and their use during pregnancy and lactation. Additionally, the center will expand, enhance and disseminate knowledge regarding the use of medications and other environmental chemicals by pregnant and breastfeeding women worldwide.

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