Some “Cold” Hard Facts

Factors such as your baby’s age and whether they were born prematurely or have chronic health problems matter.  Very young babies (less than 3 months old) may have a more difficult time metabolizing medications in the milk and may be more susceptible to side effects like sleepiness.  Milk is also their complete diet, and some medications can reduce your milk supply.  The older your baby is, the less likely it is that the medication will cause a serious problem in your baby, but it is still a good idea to be careful.  We also consider how much of the medication typically ends up in breastmilk, and whether the medication is considered acceptable to give directly to a baby.

Many cough and cold medications come in combination products.  In some cases, you end up taking extra medications for a symptom you do not have!  Also, some medications act together to make more problems.  For example, decongestants and antihistamines taken together may have extra ability to reduce milk supply.  Taking a single medication at a time lets you be sure you are using only the one that you need.

Consider whether your symptoms need medical treatment…is it worth the potential exposure to your baby, especially since many medications have not been studied very well in breastfeeding?  Non-medication strategies like a humidifier, warm shower or bath, or nasal irrigation with saline may be comforting.

Most vitamins or minerals taken over the recommended daily allowance (RDA) have not been studied very well in breastfeeding. Herbal agents are also poorly studied, which makes it difficult to tell if they are hazardous or not in breastfeeding. In general, supplements like this should be avoided.

Fever and Body Aches

Common medications to treat these symptoms are acetaminophen and ibuprofen.  Both end up in breastmilk in only small amounts and can be given directly to babies. When used as recommended on the label these medications are unlikely to harm your baby.

Aspirin is not given to babies because it may cause bleeding or a condition called Reye syndrome (swelling of the brain). Very little aspirin gets into breastmilk, but to be on the safe side you may want to be cautious about taking it when you are breastfeeding unless it is prescribed for a medical condition and your baby’s health provider agrees with use.

The Sniffles (medications that dry up your nose like decongestants and antihistamines)

Over-the-counter nasal decongestants fall into two categories: oral and topical/spray.

Oral (pill) decongestants include pseudoephedrine and phenylephrine. These medications are not given directly to babies and can make them jittery and sleep poorly, and may also reduce your milk supply. 

Oral (pill) antihistamines include chlorpheniramine, doxylamine, and diphenhydramine. Varying amounts get into milk; they can make your baby sleepy or irritable, and may reduce your milk supply.  They are also not medications given directly to babies.

Topical (spray) decongestants such as oxymetazoline have not been studied very well in breastfeeding.  However, they are not very well absorbed from your nose, and thus not much is likely to get into your milk.

Cough

The most common over the counter cough medications are dextromethorphan (cough suppressant) and guaifenesin (loosens up mucous).  Not much dextromethorphan gets into milk; it is not known if guaifenesin gets into your milk.  Some cough syrups contain alcohol, which would be a hazard for your baby.  Be sure to check your label.

Cough lozenges may just have sugar and flavoring, or may include honey, menthol, zinc, or herbal agents.  Read your label before you take the medicinal ones since many components have not been studied very well in breastfeeding.

We hope you feel better soon, and if you have further questions or notice side effects in your baby that you suspect may be related to a medication you are taking, speak with your baby’s healthcare provider.

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MotherToBaby Teratogen Information Specialists (TIS) are experts at answering questions about any possible increased risk of taking an over-the-counter (OTC) or prescribed medication, as well as any other exposures! A teratogen is something that can increase the risk for birth defects to the developing baby, and other problems such as a smaller baby or early delivery, when exposure occurs during pregnancy. Special intensive training is required to become a TIS, before we are able to answer the questions of healthcare providers, pregnant and lactating people, their relatives and partners, prospective adoptive parents, and the public. We get calls from people of all ages, teens up to older adults, even prospective grandparents. Teratogen specialists learn how to investigate the question, summarize the data, and then communicate it in a way that is easily understood. Every contact is a little different because each scenario is different, but that makes each day endlessly fascinating for those at MotherToBaby who respond to your inquires.

This work is different than the work of other healthcare providers such as a genetic counselor, midwife or obstetrician – we don’t generally delve into family history, and we don’t make direct recommendations. We try to be reassuring as we give you the most up-to-date exposure information. We consider the potential effects of taking AND not taking a medication, herbal supplement, or OTC drug. There are important considerations when someone is planning a pregnancy, facing a newly discovered pregnancy or an unanticipated pregnancy, dealing with worsening mental or physical health conditions, or with the sudden diagnosis of a birth defect or pregnancy loss.

We answer questions from prospective adoptive parents who may only have 36 hours to decide if they will accept a baby whose biological mom used heroin, methamphetamine or alcohol in pregnancy. We listen to pregnant callers worried about the substantial alcohol they drank or the marijuana they used before getting a positive pregnancy test. We also answer questions from people worried about Zika virus exposure on their honeymoons. And common questions these days involve the COVID-19 virus and the COVID vaccines and booster shoots given at any time in pregnancy or while breastfeeding.                                                  

Teratogen specialists also get calls about the potential consequences of pain medications for those who are pregnant and facing surgery such as a pre-op visit for a herniated disc – and are in excruciating pain. We have numerous conversations with lactating women who were advised to “pump and dump” after dental work or general anesthesia, or CT scans and we are able to discuss why this dated practice is usually unnecessary. Some people call repeatedly due to anxiety or simply because our TIS team has reliable expertise. We also answer breastfeeding questions about COVID-19 and the vaccines, prescriptions and OTC medications, or how much of a drug gets into breastmilk.  And we get questions from pregnant and postpartum individuals who are trying to avoid using inhalers or taking their anxiety/nausea/ADHD medications. We share the research and reassure them that some health conditions need to be treated with medications because it’s best for mom and baby. Some conversations are more sensitive – such as women with a history of multiple miscarriages, IVF, or other high-risk pregnancies who are trying to make only the best choices in a high-stakes stressful time. Sometimes there are tears, and that’s OK.

Often, we talk about the benefits to the individual of taking/using the medication or other product, versus any possible risks to the pregnancy or the baby. We tell them to consider the long view, that as a parent, you will be making “risk vs. benefit” decisions for nearly the next two decades for the child growing inside you. So, it’s important for you to make a choice now that gives you a good quality of life, and also to consider every aspect of the consequences for you both mentally and physically. In addition, it is in the important input of your partner and your healthcare providers.

It is a privilege to be part of the lives of all those who come to MotherToBaby for information. We are sensitive to different cultures, backgrounds, sexual orientation, and gender identification. We have 12 affiliate offices in the US and one in Canada. We provide information by phone, text, email, and live chat, and because we work across three times zones, we can respond quickly!

Affiliate offices are based in universities, academic medical centers, or health departments. Our multi-disciplinary team of Teratogen Information Specialists includes genetic counselors, nurses, doctors, and others with a master’s degree or Master of Public Health specifically. We also provide services in Spanish. We meet at least annually for training plus more often within our own institutions to discuss new publications and developments in the field.

Please spread the word. We welcome your inquiries!

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With Birth Defects Prevention Month in full swing, it’s time to focus on Tip #2 for Preventing Birth Defects: Booking a visit with your health care provider before stopping or starting any medicine.

Callers to MotherToBaby often wonder why it’s important to talk with their health care provider before stopping or starting a medication. My most recent caller to MotherToBaby asked this very question.

Maria contacted us at MotherToBaby telling us that she and her partner had decided that they would like to start a family. Like many women, Maria was taking medications for a health condition, and she wanted to learn if it would be OK to use them while trying to get pregnant and during pregnancy. She was planning to stop taking them because she was worried that they could be harmful for her baby. She told me that she felt alone as she faced this decision.

In fact, Maria is not alone; 70 percent of women need to take prescription medication during pregnancy to treat a wide variety of health conditions, like depression, asthma, diabetes, nausea and vomiting of pregnancy and inflammatory bowel disease.. And most women (90 percent) report using over-the-counter medication, vitamins or supplements for overall health or for specific health concerns, such as acne, allergies, colds, constipation, headaches and lice .

Why should you talk with you health care provider before starting or stopping taking medication?

Here’s why it’s important to check with your providers about taking medications and supplements before and during pregnancy:

• Some medications or herbal products can make it harder to get pregnant. And some medications can help you get pregnant.
• In some cases, stopping a medication and having an untreated medical condition may be more of a concern for pregnancy than the medications used to treat it. If a medicine can be harmful during pregnancy, your provider may want to switch you to one that’s safer for your baby. But some medications are necessary, even if they may be risky for your baby. You and your provider can talk about all your treatment options to make the best decision for you and your baby. Some medications can cause you to go through withdrawal (have unpleasant physical and/or mental symptoms) if you stop suddenly (also called “cold turkey”). If you and your provider decide to stop a treatment, you may need to stop taking the medicine slowly over time rather than stopping all at once.
• Some medications may need to be increased or decreased during pregnancy in order to continue working properly.
• Some vitamins and supplements may have too much or too little of the nutrients that you need during pregnancy. You may need to adjust the amount you take.
• Supplements and herbal products are not regulated by the Food and Drug Administration. There are no standards for ingredients and strength, and most have been poorly studied regarding their safety for use in a pregnancy.

Now that you know why it’s important to check on the safety of medication before and during pregnancy, what’s next?

• Whether you are planning a pregnancy or currently pregnant, talk to your health care providers before starting any medication (prescription or over-the-counter), vitamins or herbal products.
• Don’t stop taking your prescription medication unless your health care provider says that it is OK.
• Make appointments with your health care providers to review medications they prescribe, and make an appointment with your prenatal provider. If you are planning a pregnancy, talk with your providers before you get pregnant; and talk with them again as soon as you find out that you are pregnant.
• Tell your provider about any medicine you take, including medications that you only use once in a while, like seasonal allergy medication or rescue inhalers. Tell them about over-the-counter medicines, supplements and herbal products, too. A product may be made from herbs if it has word on the label like indigenous or tribal medicine, traditional Chinese medicine, natural remedies, herbal supplements, nutritional shakes, essential oils and tinctures.
• Start taking a prenatal vitamin as soon as you stop your birth control. Talk to your provider about which prenatal vitamin to take.

How can you get ready to talk to your providers about medication and pregnancy?

• Prepare and bring with you a list of all the medications and supplements that you take, including the ones you may only take occasionally.
  • Bring all pill bottles/boxes with you to the appointment so your provider can check on the active ingredients.
  • For each medication/supplement on your list, include information on:
    • Dosage (how much you take),
    • Frequency (how often you take it), and
    • Indication (why you are taking it).
• Some medications can stay in the body for a long time. If your treatment plan includes stopping a medication before getting pregnant, discuss the timing of when you should stop.
• There may be alternative treatments that work just as well for you and are better options during pregnancy and breastfeeding.
  • Ask about alternative treatments. Find out if you can try them out before pregnancy to see if they will work for you.

• Talk about the right prenatal vitamins with the right amount of folic acid for you.
  • Some medications can affect how your body uses folic acid, which is important for pregnancy.
  • Ask your prenatal provider to prescribe you a prenatal vitamin to make the choice easier.

After our call, Maria felt more comfortable in learning about her medications and questions she should have ready to discuss with her providers about the best way to treat her medical condition throughout her pregnancy.

Remember, just like Maria, you are not alone. MotherToBaby is here to help you and your providers work together to make informed decisions about your medication options for pregnancy and breastfeeding.

Ginger Nichols is a licensed certified genetic counselor based in Farmington, Connecticut. She currently works for MotherToBaby CT, which is housed at UCONN Health in the Division of Human Genetics, Department of Genetics and Genome Sciences. She obtained her Bachelor of Science degree in Biology and Sociology from Juniata College and her Master’s Degree in Medical Genetics from the University of Cincinnati. She has a special interest in occupational and environmental exposures.

About MotherToBaby

MotherToBaby is 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.

Selected References:

• Bohio R, et al. 2016. Utilization of over the counter medication among pregnant women; a cross-sectional study conducted at Isra University Hospital, Hyderabad. J Pak Med Assoc. 66(1):68-71.
• Centers for Disease Control and Prevention (CDC). 2018. Treating for Two: Medicine and Pregnancy. https://www.cdc.gov/pregnancy/meds/treatingfortwo/facts.html [Accessed 11/2018]
• Tasnif Y, et al. 2016. Pregnancy-related pharmacokinetic changes. Clin Pharmacol Ther. 100(1):53-62.
• U.S. Food and Drug Administration (FDA). 2018. Medicine and Pregnancy. https://www.fda.gov/forconsumers/byaudience/forwomen/ucm118567.htm [Accessed 11/2018].

The post Birth Defects Prevention Month Series: Making Medication Decisions in Pregnancy Doesn’t Have to Be Lonely appeared first on MotherToBaby.

During the more than 30 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 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. These kinds of misinterpretations are really the opposite of the goal for January’s Birth Defects Prevention Month, “Making Healthy Choices to Prevent Birth Defects.” Confusing drug categories are not leading to healthy choices all of the time. Well, the misinterpretations are all about to change as a new drug labeling rule goes into effect…. What a fresh start to the new year!

But first, a little background…

For decades the Food and Drug Administration (FDA) had been aware of significant problems with the system used to categorize medications for use in pregnancy. In 1992, the Teratology Society, 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 just before the new year, 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 continued to be listed 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, which goes into effect on June 30th of this year, a new set of requirements will be 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. Happy New Year and here’s to a less confusing year of making healthy choices about medications in pregnancy and breastfeeding!

Help spread the word about Birth Defects Prevention Month by sharing the following link: http://www.nbdpn.org/national_birth_defects_prevent.php

Lynn Martinez is a Senior Teratogen Information Specialist with MotherToBaby Utah, a program with the health department and University of Utah that aims to educate women about medications and more during pregnancy and breastfeeding. Along with answered questions from women and health providers regarding exposures during pregnancy/breastfeeding via MotherToBaby’s toll-free hotline and email counseling service. Lynn has also traveled around the state educating doctors, nurse midwives, pharmacists and others over the past three decades.

Julia Robertson, CPM, is the program manager for MotherToBaby’s Utah affiliate. She has authored 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

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One day in early June I received a frantic call from a woman who had first called Georgia’s Poison Control Center worried about the agent used to treat her varicose veins. She thought that she did the right thing by postponing her treatment until after she gave birth, but now was concerned about breastfeeding her newborn. The medical director at poison control, who is one of our advisory board members, gave her the correct information: “Call Pat Olney at MotherToBaby!”

The caller’s vascular surgeon advised her to pump her breast milk over the next 24-48 hours, and discard it; otherwise known as pump and dump. The first thing she did before calling poison control was surf the Internet for answers. She began feeling guilty about having had the procedure. She lamented, “Why didn’t I wait until after my baby was done nursing!”

First, I needed to learn a little bit about varicose veins. Varicose veins are more common in women than men, and women may first develop varicose veins during pregnancy. Pregnancy puts an added burden on the veins as the amount of blood flowing through the veins increases. Veins in the legs are already working against gravity, and pressure from the increased blood volume can cause veins to swell and bulge near the surface of the skin. They tend to get worse with each subsequent pregnancy, as women get older, or if a woman is overweight. Varicose veins can be very painful. Typically, the problem tends to improve after delivery. For our caller, the pain and discomfort continued and she decided to seek treatment.

The agent used for her varicose vein treatment was sodium tetradecyl sulfate (STS). I consulted my brand new 2014 edition of Dr. Thomas Hale’s manual of lactational pharmacology, “Medications & Mother’s Milk.” Dr. Hale’s book is used all over the world, and he is recognized as an expert in this highly specialized field. STS, a sclerosing agent, is injected into the affected vein. Dr. Hale describes this agent: “…an anionic surfactant which causes local inflammation, and thrombus formation, thereby occluding and eventually obliterating the affected vein.” He goes on to say “severe reactions such as anaphylactic shock, pulmonary embolism have been reported, although rare.”

Sounds terrible, doesn’t it? I said to myself…no wonder this woman called poison control!

Dr. Hale developed the following lactation risk categories:
L1 Compatible: drug has been taken by a large number of breastfeeding women without any observed increase in adverse effects in the infant; controlled studies fail to demonstrate a risk to the infant, or the product is not orally bioavailable in an infant

L2 Probably compatible: drug has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant, and/or the evidence of a demonstrated risk is remote

L3 Probably compatible: there are no controlled studies in breastfeeding women; however, the risk of untoward effects to breastfed infant is possible, or controlled studies show only minimal non-threatening adverse effects; drugs should be given only if potential benefit justifies potential risk to infant; new medications that have no published data are automatically categorized in this category, regardless of how safe they may be

L4 Possibly hazardous: positive evidence of risk to breastfed infant or to breast milk production; benefits of use may be acceptable despite the risk to infant; e.g. if the drug is needed in a life-threatening situation or a serious disease for which safer drugs cannot be used or are ineffective

L5 Hazardous: studies in breastfeeding mothers have demonstrated significant and documented risk to the infant based on human experience, or is a medication that has a high risk of causing significant damage to infant; drug is contraindicated in women breastfeeding an infant

Did the vascular surgeon give our caller the correct information?

Sodium tetradecyl sulfate falls into lactation category L3. There are no studies done in nursing women, and there is no data on its transfer into human milk. Dr. Hale goes on and states, “This product could be hazardous if introduced in the infant through breast milk. Therefore, extreme caution is recommended with its use in a lactating mother.”

Since there are no published studies, and no data, our caller was given the correct advice: pump and dump. Fortunately, her baby was already taking an occasional bottle, so she thought the baby would easily switch back to breastfeeding.

Sometimes the advice given to lactating mothers is not so straightforward. As summarized in a clinical report published by the American Academy of Pediatrics (AAP), “Many breastfeeding women are wrongly advised to stop taking necessary medications or to discontinue nursing because of potential harmful effects on their infants. Not all drugs are present in clinically significant amounts in human milk or pose a risk to the infant. Certain classes of drugs can be problematic, either because of accumulation in breast milk or due to their effects on the nursing infant or mother.”

When counseling a woman who has chosen to give her baby the best start in life, it’s important to get the facts, even if evidence-based information is lacking.

Questions? For your FREE personalized risk assessment, call MotherToBaby toll-FREE (866) 626-6847. MotherToBaby is a service of the international non-profit Organization of Teratology Information Specialists (OTIS), a society that supports and contributes to worldwide initiatives for teratology education and research. MotherToBaby affiliates and OTIS are suggested resources by many agencies, including the Centers for Disease Control and Prevention (CDC), and are dedicated to providing evidence-based information to mothers, health care professionals, and the general public about medications and other exposures during pregnancy and while breastfeeding. Learn more at MotherToBaby.org.

Patricia Olney, MS, is a certified genetic counselor and pregnancy risk specialist at MotherToBaby Georgia, Emory University. She received her masters degree at the University of California, Berkeley and has practiced genetic counseling for more than 25 years. MotherToBaby GA is funded by the Georgia Department of Behavioral Health and Developmental Disabilities.

Reference:
The American Academy of Pediatrics (AAP) August 2013 “The Transfer of Drugs and Therapeutics Into Human Breast Milk: An Update on Selected Topics.”

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