Can Moms Who Had a Transplant Breastfeed While Taking Tacrolimus?

By LauraAnne Hirschler, BS, OMS4 with help from Casey Rosen-Carole, MD, MPH, MSEd, FABM and Rogelio Perez-D’Gregorio, MD, MS

As an infant, I received the gift of life in the form of a liver transplant. Growing up, I remember taking a multitude of medications that just became part of my daily life. As the years went on, my immune system became stronger, the transplant check-ups became farther and farther in between. As the years went by, I found myself taking an extremely low dose of one immunosuppressant called tacrolimus. Inspired by my personal journey as a transplant patient, I went to medical school with a passion to care for patients as my healthcare providers had cared for me. During my training as a physician, I began to become interested in how the medicines that a person needs to take can impact pregnancy and breastfeeding.

With this interest in women’s health, I pursued a rotation in Breastfeeding and Lactation Medicine. I worked alongside an amazing team of lactation specialists to help patients achieve their breastfeeding goals. I reviewed the medications that new moms were prescribed to make sure that they would address the medical needs of the mom and also have the lowest risk of impacting their developing baby. With a desire for a family of my own, I wanted to learn more about taking tacrolimus while breastfeeding. I saw firsthand how beneficial breastfeeding was and wondered if taking this medication multiple times per day would pose any risk for my developing baby. Would I ever be able to breastfeed?

Tacrolimus (Prograf®, Envarsus®,  Astagraf®) is a medicine used by people who have had a transplant, like liver, kidney, or heart transplants. It helps prevent the body from rejecting the new organ. It’s usually taken as a pill, but it can also be taken as an IV, as a liquid, or applied to the skin for conditions like eczema.

I found that research studies have shown promising evidence that breastfeeding while taking tacrolimus is most likely not of concern for breastfed children. One study looked at a mom who took tacrolimus twice a day. After one dose, scientists checked her breast milk and found a very small amount of tacrolimus in the milk. The amount was much lower than what is given directly to babies who need the medication.

One study involved a breastfeeding heart transplant patient who took tacrolimus throughout her pregnancy and after birth. When her baby turned one month old, tacrolimus blood levels were measured in both mom and baby. This baby’s tacrolimus levels were extremely low.

Another study examined three exclusively breastfed infants and one partially breastfed infant whose mothers took oral tacrolimus. Researchers measured tacrolimus amounts in these infants between age of 15-27 days of life. None of the babies had detectable tacrolimus levels in their blood. 

One of the largest studies was performed by the National Transplantation Pregnancy Registry. It looked at 68 mothers who had liver or kidney transplants. The study followed 83 babies, some for as long as 16 years. None of the babies had medical problems related to their mother’s use of tacrolimus.

Tacrolimus is also used in cream form for conditions like eczema. The good news is that the risk of this cream affecting a breastfeeding baby is very low because only a small amount of the cream enters the mom’s body. However, if the cream is applied to the nipple, it should be cleaned off before the baby nurses. If a topical nipple treatment is needed, some experts recommend pimecrolimus cream over tacrolimus because it does not contain paraffin. Other treatments such as hydrocortisone ointments are better studied and are usually used first.

Breastfeeding while taking tacrolimus has been shown to be a low risk for breastfed babies. Since breast milk has many health benefits for babies, healthcare providers recommend moms who are taking tacrolimus breastfeed their babies. As with any health condition, a discussion with your healthcare provider is needed to weigh risks and benefits to determine the right choice for your family.

After learning more about the safety of breastfeeding while taking tacrolimus, I feel empowered and encouraged to breastfeed my future children, especially since breastmilk is so healthy and nourishing for babies.

References/Resources


Can Moms Who Had a Transplant Breastfeed While Taking Tacrolimus?

By Kirstie Perrotta, MPH and Sonia Alvarado, MotherToBaby California

With wildfires seemingly becoming a year-round problem, pregnant women have more questions than ever before about exposure to smoke and lingering poor air quality. Understanding the possible risks from a fire during pregnancy or while breastfeeding can help people make informed decisions when the unthinkable happens. Here are some commonly asked questions we receive at MotherToBaby about wildfires.

Q. What is in the air from the fires?
A wildfire produces particulate matter (a combination of dirt, soil dust, pollens, molds, ashes, and soot), in addition to other chemicals. The particulate matter can be different sizes. Particles less than 10 micrometers in diameter pose the greatest problems, because they can get deep into your lungs, and some may even enter your bloodstream. Contents of the smoke can vary based on what is being burned. In some instances, wildfire smoke can contain heavy metals such as lead. Wildfire smoke also contains carbon monoxide.

Q. I’m pregnant. How does the particulate matter affect my pregnancy? What about the carbon monoxide?
Experts tell us that the smaller the particulate matter, the worse the effects on health, including difficulty breathing, aggravated asthma, and increased risk of heart attack and death due to respiratory and cardiovascular problems. Although we do not know enough about how exposure to particulates can impact a pregnancy, it makes sense for all individuals to take extra precautions to reduce their exposure to wildfire smoke.

Carbon monoxide is a gas that enters into the lungs and blood and displaces oxygen to both mom and baby. The greater the exposure and the longer the exposure, the higher the risk. Studies suggest that there may be a higher chance of birth defects when a woman is exposed to carbon monoxide in the first trimester, but more studies are needed. Other studies have found that exposure to wildfire smoke can increase the risk for preterm delivery and low birth weight. However, this finding may be more related to the stress a woman experiences during a fire, or a combination of factors, than the actual smoke exposure. Again, more research is needed.

Q. I have asthma and I’m pregnant. Do I have added risks?
Yes. Studies in non-pregnant women tell us that exposure to particulate matter of 10 micrometers in diameter or less can make asthma symptoms worse. Pregnancy would not protect you and it may even put you at higher risk of having an asthma attack depending on how far along you are. See our fact sheet on asthma here.

Depending on your proximity to the fire zone, it may be difficult to get help if your symptoms worsen. First responders may be busy fighting the fires and evacuating residents and may not get to you as quickly as you need. Emergency rooms may be overrun. For this reason, it is very important to always have your asthma medication with you so that if the smoke exacerbates your symptoms you can start to treat yourself. You also want to be in contact with your doctor and move away from the source of the wildfires as soon as possible.

Q. I’m pregnant and work outdoors. Do I need a mask?
The U.S. Environmental Protection Agency (EPA) has recommendations about what masks to use to protect against particulate matter entering the lungs. The goal is to prevent or reduce exposure as much as possible. If you work indoors, for the most part you are protected. If you work outdoors, you may want to consider using a mask that fits correctly and has two head straps to hold it in place. It should be labeled “particulate respirator” and it should have been tested or approved by the National Institute for Occupational Safety and Health (NIOSH). Learn more here. Since pregnancy can alter your lung function, pregnant women may have a harder time breathing to begin with. For that reason, it’s important to check in with your healthcare provider before using a particulate respirator.

If you are concerned about your work conditions, NIOSH offers a program called The Health Hazard Evaluation Program. This program helps employees learn whether health hazards are present at their workplace and recommends ways to reduce hazards and prevent work-related illness. Learn more here.

Q. I live about 50 miles from the wildfires. Do I still have to be concerned about being outdoors?
Depending on where you live and the direction of the wind, the air quality in your area may be poor due to the wildfire, even if the fire isn’t that close to you. Listen to the local health and environmental officials, and avoid exercising outdoors, gardening, or performing other activities that may cause you to exert yourself and inhale more of the particulates in the air. If you have any doubts, wait until the wildfires have been extinguished and the air quality is back to normal.

Q: Can fires cause other problems for pregnant women?
Depending on weather conditions, wildfires can spread rapidly. The stress of having to make life and death choices, or the decision to leave your home and decide what items to take with very short notice, all produce tremendous stress. It is absolutely normal to feel sad, stressed, anxious, or scared. In pregnancy, depending on how long the stress is present and the level of stress, it is possible that there could be impacts on the developing baby, so anything you can do to try to reduce stress is always a good idea. Take a look at our fact sheet on stress for more information:

Q: I’m pregnant. What if I have to evacuate?
The best thing that you can do is have a plan in place ahead of time. Make a checklist of items to take with you should you need to evacuate your home. Assemble an emergency supply kit and store it in a location where you can easily get to it, and create a family communication plan.

When the time comes to evacuate, stay calm. Be sure to bring any medications that you take on a daily basis (including your prenatal vitamins). Stay well hydrated, continue to eat, and rest as much as you can. If you have to check into a shelter, tell the staff there that you are pregnant so they can make any necessary accommodations.

While making it to your prenatal check-up is probably the last thing on your mind in the midst of an evacuation, it’s important that you continue to be seen by your OB/GYN or midwife. Some individuals may be displaced from their homes for an extended period of time, however, it’s important to keep attending your prenatal care visits to make sure that baby is growing and developing properly.

If you’re close to your due date, check to make sure your hospital or birthing center is not in the mandatory evacuation zone. If it is located close to the fires, the staff and patients there may be asked to evacuate, and you may need to deliver at a different hospital. Knowing this information before you go into labor will reduce any unnecessary stress.

Q: What other steps can I take to minimize my exposure to smoke from a fire?
Stay indoors when possible, and keep your windows and doors closed. If available, an air purifier can help with indoor air quality. If you have to drive somewhere, keep your windows rolled up and use the air conditioner to stay cool. If your car has a button that recirculates air internally, make sure it is turned on. Pregnant women who must venture outdoors may also consider wearing a mask. Although any protection is helpful, a N95 particulate respirator works best to filter out harmful particulate matter.

Q. I’m breastfeeding and I’m concerned about the wildfires in my area
Breastfeeding moms can also face challenges of their own when they have to evacuate their homes. When possible, follow the steps outlined above to reduce exposure to the wildfire smoke for both you and baby.

The benefits of breastfeeding are well known, and in most cases individuals are encouraged to continue to breastfeed their babies even when faced with an emergency like a fire. Women who are nursing should focus on staying well hydrated and continue to feed baby on demand.

For moms that choose to pump breast milk, extra batteries may be something worth packing in your emergency supply kit in case the power goes out. For babies that are formula fed, it’s important to bring bottled water.

Q: Where can I learn more about fires currently happening and about air quality where I live?

The U.S. Department of Agriculture (USDA) Forest Service reports on large fires nationally. The EPA also has a website where you can check the air quality index in your local area. Pregnant women should follow instructions laid out for “sensitive individuals.” Lastly, the Centers for Disease Control and Prevention (CDC) has more helpful information about wildfire exposure during pregnancy here.


Can Moms Who Had a Transplant Breastfeed While Taking Tacrolimus?

By Angela Messer, MS, Teratogen Information Specialist, MotherToBaby California

“I love the way my eyebrows look!” Emily just found out she was 6 weeks pregnant, and had started the process of microblading (a cosmetic tattooing technique, in which a tool made of small needles is used to add semi-permanent pigment to the skin; resembling the hair on the brow) before she knew she was pregnant. Logging into the MotherToBaby chat for some guidance, after online searching resulted in mixed answers, she wanted to know if it was still ok to continue microblading during her pregnancy.

Emily’s question is a common one we receive here at MotherToBaby. With new and upcoming products in the beauty industry, many women want to know if it is ok to start or continue treatments like microblading when they become pregnant. Procedures like these often require more than one visit, broken up between weeks or even months. For pregnant women, the “nine month stretch” raises questions about their use in pregnancy.

The difficulty in answering a question like Emily’s comes down to the lack of information about these types of procedures in pregnancy and also while breastfeeding. Without the research available, we simply do not know about how they may, or may not, affect your pregnancy or your breastfed infant.

Ink

The pigments used in microblading are made up of different types of chemical compounds, like oxides, which can be pre-mixed and purchased by the cosmetic tattoo artist. They may also be mixed by the professionals themselves. A few unknowns are how much pigment, if any, is going into the skin, is entering the mom’s blood, crossing the placenta, and reaching the baby – which also means we do not know if the ingredients in the pigment could pose any risk. The same goes for breastfeeding moms – without good data, we do not know how much pigment, if any, is getting into the milk reaching the breastfed baby.

Possibility of infection

Another thing to consider about microblading in pregnancy and breastfeeding is the risk for infection. As previously mentioned, during the microblading process, a cosmetic tattoo artist deposits pigment into the outer layer of the skin by penetrating the skin with tiny needles. There is a possibility that the needles used may not be completely sterilized, which can lead to a higher risk of health issues such as staph infection, abscess, skin inflammation, or other infections like Hepatitis B and HIV. Medications like antibiotics may be needed to treat these conditions, sometimes requiring weeks or months of treatment. If left untreated, they can lead to health issues for mom and baby. Visiting a reputable business with good hygiene practices in place is a good idea should you choose to have microblading done during pregnancy or while breastfeeding.

Pain

Some women report that the microblading treatment can be painful. If that’s the case, the cosmetic tattoo artist may recommend the use of additional medications to control the pain (e.g. a topical lidocaine cream, or Tylenol). During pregnancy and breastfeeding, Tylenol (acetaminophen) is considered by most healthcare professionals to be the preferred pain reliever: https://mothertobaby.org/fact-sheets/acetaminophen-pregnancy/. With topical exposures, like lidocaine cream, a significant amount is generally not expected to enter the mom’s blood and result in an exposure to the pregnancy. Consider these additional exposures during pregnancy or while breastfeeding when deciding whether or not to book an appointment.

With all these unknowns in mind, it can be difficult to evaluate what possible risks a developing baby or breastfed infant might face. Ultimately it comes down to weighing the risks vs. the benefits, and this is exactly what I discussed with Emily on our chat. Having gone to a licensed cosmetic tattoo artist, Emily was reassured that her microblading procedure early in pregnancy was unlikely to be a concern. Moving forward, she decided that given the lack of research, she would prefer to wait until she was no longer pregnant or breastfeeding to resume further treatment. “My eyebrows might not look as great for the next year, but I won’t have to constantly worry about the ink reaching the baby or the possibility of infection from having this done!” she shared as we wrapped up the chat.

If you have questions about microblading while pregnant or breastfeeding, don’t hesitate to contact a MotherToBaby specialist via phone, text, chat, or email.

Angela Messer, MS, is a Teratogen Information Specialist with MotherToBaby California. She earned her undergraduate degree in psychology from Chapman University and her Master’s degree from Kansas State University in academic advising/counseling.  Angela has been with MotherToBaby since 2009 and holds a special interest in maternal medical conditions in pregnancy. In her free time, she enjoys spending time in her hometown of San Diego, CA with her husband and 9 month old daughter.

About MotherToBaby 

MotherToBabyis a service of the Organization of Teratology Information Specialists (OTIS), suggested resources by many agencies including the Centers for Disease Control and Prevention (CDC). If you have questions about exposures during pregnancy and breastfeeding, please call MotherToBaby toll-FREE at 866-626-6847 or try out MotherToBaby’s new text information service by texting questions to (855) 999-3525. You can also visit MotherToBaby.org to browse a library of fact sheets about dozens of viruses, medications, vaccines, alcohol, diseases, or other exposures during pregnancy and breastfeeding or connect with all of our resources by downloading the new MotherToBaby free app, available on Android and iOS markets. Also, make sure to subscribe to The MotherToBaby Podcast available on iTunes, Google Play Music, Spotify and podcatchers everywhere.


Can Moms Who Had a Transplant Breastfeed While Taking Tacrolimus?

By Al Romeo, RN, PhD, MotherToBaby Utah

If you are pregnant or breastfeeding, you might wonder if it is safe for you to go to the nail salon. After all, there are chemicals in nail treatments, and (let’s face it) nail salons often smell like they could be toxic! But are they?

What’s in nail treatments? And could they be harmful if I’m pregnant or nursing?
Common nail products include nail polish and types of acrylic nails including gels, liquids, and powders. There are a few ingredients that are commonly found in those products, including:

  • Dibutyl phthalate (DBP)
  • Toluene
  • Formaldehyde
  • Camphor
  • Paraffin
  • Methacrylic
  • Acetone
  • Acetonitrile

The names of those ingredients may sound scary, but let’s look at each of them.

Dibutyl phthalate (DBP) is used in nail polish to make the polish more flexible and less likely to crack or break. Small amounts have been found in humans. Those small amounts are not expected to cause increased chances of problems for the pregnancy or breastfed baby based on the available research.

Toluene is a solvent that is used to thin nail polish so it goes smooth after being painted on with a brush. Solvents are known to be harmful to the nervous system. Sniffing or huffing spray paint, glue, and gasoline can cause dizziness and fainting in addition to damaging brain cells. But when it comes to nail treatments, the amount of toluene that is absorbed through the skin or inhaled from applying nail polish to finger and toe nails is small and not expected to increase the chance of problems for your pregnancy or breastfed baby.

Formaldehyde is used to harden nail polish. Nail salons might also use formaldehyde to disinfect nail care tools. Some people may be allergic to formaldehyde, even in the small amounts found in nail polish. Women with those allergies should use nail care products without formaldehyde and ask about its use in nail salons. Our bodies make formaldehyde and it can be found in healthy foods, such as apples. Just as too much water or oxygen can be dangerous for our bodies, too much formaldehyde can be a problem. However, the amount in nail polish is small and the amount that would be absorbed through the skin, nails, and from the fumes is also very small. That small amount is not expected to cause problems for your pregnancy or breastfed baby.

Camphor is also used to make nail polish soft or flexible and give it a pleasant odor. Camphor is found in some pain-relieving products that are applied to the skin. The amount of camphor in nail polish is far less than in those pain-relieving creams. Based on the limited information available, the use of camphor on the skin has not increased risks for a pregnancy or breastfed babies.

Paraffin is a mineral oil used in cosmetics and ointments to soften the skin. It isn’t part of the nail polish or remover, but your hands or feet might soak in it as part of the manicure or pedicure. As an oil, it mainly stays on the skin and isn’t absorbed into the bloodstream. The small amount of paraffin that is expected to get absorbed into the skin is not expected to increase the chance of problems for your pregnancy or breastfed baby.

Methacrylate is a chemical in acrylic nails. Not much of the methacrylate is left after it reacts with other chemicals to form the acrylic nails. However, the small amount that is left in the acrylic nails could cause irritation, redness, and swelling in the tissues under and below the nails. The small amount of methacrylate that is expected to be absorbed by the skin or lungs from using acrylic nails is not expected to cause an increased chance of problems for your pregnancy or breastfed baby.

Acetone is a solvent used in nail polish removers. Acetone, when ingested, can cause problems in the body. The small amount of acetone that is expected to be absorbed by the skin or lungs when it is used to remove nail polish is small and not expected to cause an increased chance of problems for your pregnancy or breastfed baby. After using nail polish remover, you might want to wash your hands or feet to reduce the amount that is left on the skin that could be absorbed.

Acetonitrile is another solvent used for removing artificial nails. It is less commonly used in cosmetics than acetone. The small amounts that are expected to be absorbed through the skin, nails, or lungs are not expected to increase the chances of problems for your pregnancy or breastfed baby.

But what about the smell?
The smell in nail salons is caused by the chemicals in the various treatments they offer. If there is good air flow and plenty of fresh air, then it is not likely that much of the chemicals will get into the body by breathing the fumes. But if you have headaches, dizziness, or nausea while around nail care products, take a break and get some fresh air outside.

So what’s the take-away?
Go ahead, pamper yourself with pretty nails! Using these cosmetic products as part of routine nail treatments should not cause you any concern, as there are no known increased risks for your pregnancy or your breastfed baby.

If you have questions about exposures during pregnancy or breastfeeding, contact an expert at MotherToBaby. You can reach us by phone at 866-626-6847 or by text at 855-999-3525. You can also email or live chat with us by visiting https://MotherToBaby.org.

Alfred Romeo, RN, PhD, is a nurse and health educator. He has been with MotherToBaby for fifteen years, has served as the chair of various committees, and has served in many roles on the Board of the Organization of Teratology Information Specialists (OTIS)/ MotherToBaby. His experiences include working as a nurse in newborn intensive care units, training medical homes to improve services for children with special needs, and training young adults with disabilities in leadership and advocacy.


Can Moms Who Had a Transplant Breastfeed While Taking Tacrolimus?

By Lynn Martinez and Julia Robertson, CPM

During the more than 40 years MotherToBaby affiliates have been serving the public with education regarding exposures during pregnancy, many women have called who are very distressed, sometimes in tears, about finding out they were pregnant while taking a drug categorized as an X or D in the Food and Drug Administration (FDA) system. “I’ve been on birth control pills and I still got pregnant! Does this mean my baby will have birth defects? It’s a category X drug for goodness sake!” This kind of hysterical reaction was, unfortunately, a common call. It was not unusual to even hear that some of these women had contemplated terminations of otherwise wanted pregnancies. The FDA realized that these pregnancy categories were not as helpful as they intended and stopped using them in 2014, about ten years ago. Now they use the Pregnancy and Lactation Labeling Rule (PLLR) that has a narrative summary for medications, similar to what you will find here at MotherToBaby.

But first, a little background…

For decades the FDA had been aware of significant problems with the system used to categorize medications for use in pregnancy. In 1992, the Teratology Society (now known as the Society for Birth Defects Research and Prevention), a group of multidisciplinary scientists who study birth defects, expressed concerns and noted that the Category or ‘CAT’ system led to unnecessary terminations of wanted pregnancies1. The FDA Pregnancy Labeling Initiative recommended elimination of the CAT system, changing the label to include more descriptive risk statements and mandating that drug inserts be updated when human information is known.

Before the labeling rule changed, when a medication was approved for marketing in the U.S., it had to be labeled with one of five pregnancy CATs: A, B, C, D or X. A meant the drug was well-studied and posed no threat to a developing baby; B was a less-studied, but probably still low-risk drug; C was a drug that had not been studied and therefore the risk was unknown; a D-class drug, based on animal or human data, may have posed a risk; and the X classification meant the drug, based on animal or human data, causes birth defects or there was no benefit for its use during pregnancy. Its use was not recommended in pregnancy.

More than 90 percent of new medications were categorized as either CAT C, D or X, the vast majority being C. Drug manufacturers were legally required to update the category if harmful results were reported; however, no such requirement existed for updating the category when studies showed no problems in pregnancy. Most medications on the market in 2014 werelisted as CAT C, when in fact the majority of them should have been labeled as a CAT A or B. Manufacturers knew that no matter a woman’s history, all pregnancies carried a 3 percent risk of having a child with a major birth defect. Because of this, many manufacturers may have felt better protected from lawsuits if their drugs were listed as CAT C, D, or X. So, really, why would they move up medications in those categories up to A or B? They really didn’t have an incentive.

Moving forward and what it means to mom…

With the FDA rule change in 2014, a new set of requirements was put into place to better inform mom. It now requires the manufacturers to ‘upgrade’ a medication’s labeling when studies show the risk has changed. Also, manufacturers will have to explore various ways of discussing in detail the risks associated with the drug. One expert source that manufacturers could consult is a teratogen information service, like MotherToBaby. More information will help you make more informed choices about your health and pregnancy!

There will still be confusion…

As we see the new labels being implemented, there will still be many drugs on the market with the CAT system since it’ll take time to update all of them. MotherToBaby does not recommend the public or providers rely on the old CAT system for risk assessment. We welcome your questions about the system as well as questions about specific medications in pregnancy and breastfeeding for a complete, personalized risk assessment. Please call us toll-FREE at 866-626-6847.

Lynn Martinez is a retired Teratogen Information Specialist. Lynn has traveled around Utah educating doctors, nurse midwives, pharmacists and others over the past three decades.

Julia Robertson, CPM, now retired, works part-time overseeing quality control efforts for MotherToBaby. In her 25-year career as a teratogen information specialist, sheauthored several peer-reviewed publications focusing on maternal medication consumption and the effect on the developing fetus.

MotherToBaby is a service of the international Organization of Teratology Information Specialists (OTIS), a suggested resource by many agencies, including the Centers for Disease Control and Prevention (CDC). If you have questions about medications, alcohol, diseases, vaccines, or other exposures during pregnancy or breastfeeding, call MotherToBaby toll-FREE at 866-626-6847 or browse a library of fact sheets.

  1. Friedman, J. Teratology 1993:48:506
  2. For more information go to: http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/labeling/ucm093307.htm