DRUGS IN PREGNANCY AND LACTATION: DO NOT LET DOWN YOUR PATIENTS
Faculty:
L. Austin Fredrickson, MD, FACP
L. Austin Fredrickson is an Associate Professor of Internal Medicine at Northeast Ohio Medical University, where he serves as core faculty and teaches diagnostics, therapeutics, clinical skills, and health humanities. He is board-certified in general internal medicine and practices rural primary care.
Ashley Walsh, PharmD
Ashley Walsh is a graduate of the University of Connecticut, School of Pharmacy, with a BS in Pharmacy Studies and a Bachelor of Science in Molecular and Cell Biology.
Pamela Sardo, PharmD, BS
Pamela Sardo, PharmD, BS, is a freelance medical writer and licensed pharmacist. She is the founder and principal at Sardo Solutions in Texas. Pam received her BS from the University of Connecticut and her PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, and managed health care responsibilities across a broad range of therapeutic classes and disease states.
Abstract
Nine in ten women report taking at least one medication during pregnancy. A great need exists to provide medication safety information to all women of childbearing age. Prenatal care should start well before conception. Still, for most, prenatal care begins once they realize they are pregnant (or later), leaving a gap in care from conception to the first consultation with a healthcare provider. Identifying pregnancy and lactation status is a major barrier to intervention by pharmacy staff. In addition, women of childbearing potential may have chronic conditions requiring prescription medication. Understanding medication safety is important to improve maternal and infant health. Patient education prevents unnecessary premature infant weaning and non-adherence to medications. Although some medications are known teratogens, information about safety in pregnancy and lactation is lacking. Trusted information resources help determine appropriate medications.
Accreditation Statements
In support of improving patient care, RxCe.com LLC is jointly accredited by the Accreditation CouncilTM for Continuing Medical Education (ACCME®), the Accreditation Council for Pharmacy Education (ACPE®), and the American Nurses Credentialing Center (ANCC®), to provide continuing education for the healthcare team.
Joint Universal Activity Number: The Joint Accreditation Universal Activity Numbers assigned to this activity are as follows:
Pharmacists: JA4008424-0000-26-109-H01-P
Pharmacy Technicians: JA4008424-0000-26-109-H01-T
Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit.
Credit Types:
Pharmacy - 2 Credits
Type of Activity: Application
Media: Computer-Based Training (i.e., online courses)
Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Activity Pre-Test, Post-Test, and Activity Evaluation.
Release Date: June 24, 2026 Expiration Date: June 24, 2029
Target Audience: This educational activity is for Pharmacists and Pharmacy Technicians
How to Earn Credit: From June 25, 2026, through June 25, 2029, participants must:
Read the “learning objectives” and “author and planning team disclosures;”
Take the “Educational Activity Pre-Test;”
Study the section entitled “Educational Activity;” and
Complete the Educational Activity Post-Test and Activity Evaluation. The Educational Activity Post-Test will be graded automatically. Following successful completion of the Educational Activity Post-Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)
CE Credits: Credits for this course will be uploaded to CPE Monitor® for pharmacists and pharmacy technicians.
Statement of Need
Nine in ten women report taking at least one medication during pregnancy. A great need exists to provide medication safety information to all women of childbearing age. Identifying pregnancy and lactation status is a major barrier to intervention by pharmacy staff. This course provides information to close this gap.
Learning Objectives: Upon completion of this educational activity, participants should be able to:
Recognize common pregnancy-related ailments and medication safety resources
Describe the effects of medication use during pregnancy and lactation
List safe and effective over-the-counter medications for patients who are pregnant or lactating
Identify methods to determine pregnancy or breastfeeding status
Disclosures
The following individuals were involved in planning, developing, and/or authoring this activity: L. Austin Fredrickson, MD, FACP; Ashley Walsh, PharmD; and Pamela Sardo, PharmD, BS. None of the individuals involved in developing this activity has a conflict of interest or financial relationships related to the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.
© RxCe.com LLC 2026: All rights reserved. No reproduction of all or part of any content herein is allowed without the prior, written permission of RxCe.com LLC.
Educational Activity Pre-Test
Which is true about treating constipation in pregnancy?
Prucalopride is a first-line treatment choice
Castor oil is safe for use during any trimester
Laxatives carry no risk of nutrient deficiency
Psyllium is a supplement that increases fiber
What medication is UNSAFE during all trimesters of pregnancy?
Psyllium
Isotretinoin
Doxylamine
Vitamin B6
Which of the following medications requires close monitoring and titration for the appropriate neurologic development of the fetus?
warfarin
folic acid
levothyroxine
methylcellulose
Educational Activity
Drugs in Pregnancy and Lactation: Do Not Let Your Patients Down
Introduction
According to the Centers for Disease Control and Prevention, childbearing is a common experience among women in the United States. Nine in ten women report taking at least one medication during pregnancy. A great need exists to provide medication safety information to all women of childbearing potential. Pharmacies can expand their services and contribute towards providing care for pregnant or breastfeeding women in the community. Pharmacists can assist with ensuring medication safety for those of reproductive potential.
Women of Childbearing Potential
In the United States (US), an estimated 50% of all women experience at least one birth by age 25, and 85% have given birth by age 44.1 Since 1996, healthcare practitioners have focused on improving pregnancy outcomes by improving and promoting preconception care (PC). 1,2 The Select Panel on Preconception Care (SPPC) defines PC as “a set of interventions that aim to identify and modify biomedical, behavioral, and social risks to a woman's health or pregnancy outcome through prevention and management.” Unfortunately, there is limited evidence determining effective methods to deliver this and improve PC.1
The American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine (ASRM) describe pre-pregnancy care goals to reduce the risk of adverse health effects for the woman, fetus, and neonate. In furtherance of these goals, they recommend healthcare providers collaborate with the woman to address modifiable risk factors, optimize health, and provide education about a healthy pregnancy.3
ACOG and ASRM also recommend reviewing all medications during pregnancy counseling, including nutritional supplements and herbal products, that could affect reproduction and pregnancy.3 Despite available recommendations, millions of women and couples lack PC.1 All patients, planning and not planning a pregnancy, can benefit from PC. Reserving PC only for women planning a pregnancy risks the first prenatal visit being too late to prevent certain outcomes for the mother or infant.4 A simple recommendation for patients to take folic acid supplementation prevents neural tube defects when taken before conception and throughout the first trimester.5 Also, healthcare providers should screen male partners for androgen use, which is associated with reversible (with cessation) azoospermia (no sperm in ejaculate) and infertility in males.3
Healthcare providers should assess and address prenatal risks for “every woman, every time.”4 One Key Question is an initiative backed by ACOG and ASRM that provides a framework for healthcare providers to routinely ask: “Would you like to become pregnant in the next year?”3,6 Furthermore, any patient encounter is an opportunity to counsel about wellness, possibly improving obstetric and reproductive outcomes should they choose to reproduce.3 Pharmacists may consider adapting screening tools to provide or refer preconception care.4
| Resources for Preconception Care: Screening tools, examples, and guidance are available from the Preconception Health and Healthcare Initiative at the following link: https://beforeandbeyond.org/resources/screening-tools/ |
The American Academy of Pediatrics, World Health Organization, and Institute of Medicine concur that mothers should breastfeed exclusively for the first 6 months and continue for 1 year or longer (as mutually desired by mother and infant).8,9,10 Breastfeeding reduces infants’ risk of mortality from diarrhea or other infections. During illness, breast milk is crucial, providing energy and nutrients.10 Breast milk reduces child mortality in those who are malnourished.10 In addition to infants’ benefits, breastfeeding contributes to the health of mothers by reducing ovarian and breast cancer risk.10
Barriers to Care
Pharmacists serve as a medication resource to patients and prescribers.11 Pharmacists can provide drug information regarding toxicity during pregnancy and lactation.4 Unfortunately, recommendations regarding medications are inconsistent among scientific resources and, at times, may be conflicting.12 Since pharmacists feel their formal education lacked adequate training on maternal medication use, unnecessary disruption to breastfeeding is recommended.12
Younger women and women with learning disabilities may fail to recognize pregnancy. Patients may overlook or misinterpret early signs and symptoms. Furthermore, patients may misinterpret symptoms or attribute them to other causes. Age, health, or contraception may lower patients’ perceived likelihood of pregnancy. Patients may not understand the risk of pregnancy while using contraception. Patients may not experience any pregnancy symptoms. Others may not be self-aware enough to recognize symptoms or may be in denial. Regardless, misinterpretation and delaying care may cause adverse pregnancy outcomes.13
Patients may feel afraid, depressed, or ambivalent, resulting from a confirmed pregnancy. These emotions can lead to avoidant and delaying coping strategies. Female teenagers and women misusing substances may feel judged. This can result in feelings of anxiety, leading to pregnancy secrecy and ongoing concealment.13 Delayed decision-making or perceived obligation to terminate pregnancy may also contribute to postponing care.13
Identifying pregnant or lactating women is difficult and often a sensitive topic.12 Methods to determine status include scanning patient profiles for prenatal vitamins, physician communication, patient self-disclosure, and signature waivers (in which the patient signs a waiver declaring pregnancy status).12
Discomfort while breastfeeding in public has been associated with shortened lactation duration. Reports are available on social media depicting people shaming those who are breastfeeding or telling them they cannot breastfeed in a public place. This may cause women to avoid public breastfeeding or breastfeeding in front of individuals who make them feel uncomfortable. Patients need more support to avoid social isolation and continue lactation as desired.14
Takeaway: How would you identify pregnant or lactating patients in the pharmacy setting? |
Medication Safety
Researchers have designated only a few medications as safe and effective in pregnancy, which limits prescribers' options.11 Medication decisions are personal and complex.15 With the prescriber's recommendation, medications may be necessary when the potential benefits to the patient outweigh the risks to the infant or fetus. Table 1 lists select drugs and their risks in pregnancy and lactation.16-27 Patients who are pregnant should take the lowest effective doses of the safest medications whenever medically reasonable.
Table 1 Medications and their effects on pregnancy and lactation16-27 | ||
| Medication | Pregnancy | Lactation |
| Acebutolol | Animal data suggest low risk Crosses placenta* May lower birth weight, BP, and HR | Extensively excreted in breastmilk* |
| Acetaminophen | Avoid routine use Mixed results from animal and human data Crosses placenta | Low amounts are excreted into breastmilk 1 report of infant rash |
| Bacitracin | No reports of congenital defects* | No reports are available when used topically |
| Caffeine | No measurable risk when taken in moderation Human data suggest no association with congenital defects Teratogenic in animals± Crosses placenta | Excreted in very low amounts, probably not clinically significant Accumulation can occur with high maternal consumption May cause irritability, poor sleep |
| Dexchlorpheniramine | Low risk, avoid during the last 2 months of pregnancy No reports linking to congenital defects in human data Animal data have not shown a teratogenic effect Placental transfer is unknown, but likely occurs, as suggested by low MW | No reports available |
| Erythromycin | Animal data suggest no teratogenic Avoid estolate salt (induced hepatotoxicity observed) Crosses the placenta in very low concentrations | Low levels are excreted in breastmilk May cause diarrhea |
BP = blood pressure HR = heart rate MW = molecular weight * = Limited data in humans ± = Teratogenic only in high doses, causing maternal toxicity | ||
Pharmacy staff can discuss medication information that patients read online about safety in pregnancy.28 Certain websites may inaccurately claim a medication is safe or unsafe in pregnancy. Patients cannot trust a product’s safety merely because it says “natural.”28
Balancing risks to the infant against the potential benefits of maternal treatment and the risk of untreated disease is challenging.29 Resources are available to guide decision-making about medication risks for a pregnant or lactating patient.4,29
Pharmacists should begin evaluating medication use in pregnancy and lactation by searching the primary literature. PubMed, Ovid, ProQuest, Embase, and Web of Science are available for access to information.29 Pharmacists can also gather information using REPROTOX (a database). This source provides a summary of available primary literature and details medications’ impact during pregnancy and lactation.29
More details about medications used during lactation are available through LactMed, a peer-reviewed free database (found at www.ncbi.nlm.nih.gov/books/NBK501922). LactMed provides information about drug levels in breast milk and infant blood, drug effects on milk supply, and lactation success. It also suggests alternative therapy to harmful medications.29
Medication safety on the drug label is another source of information.29 In 2014, the Federal Drug Administration (FDA) finalized the Pregnancy and Lactation Labeling Rule to improve pregnancy and breastfeeding-related information presentation. Previously, prescribing information categorized medications by letter (A, B, C, D, and X). These letters designate drugs ranging from those with no evidence of risk to those with clear evidence of fetal risk.29,30 Since June 2015, over 2200 prescription medications have updated their labeling format.15 New labels have abandoned the letter-based system and replaced it with three categories: pregnancy, lactation, and females and males of reproductive potential.29,30 Pharmacists should refer patients for a maternal-fetal medicine consultation or genetic counseling to explore the risk-benefit profile of medications with known risks or newer medications with limited safety data.29
Takeaway: How will you balance acquiring the necessary information about drug safety with a workload? |
Adverse Pregnancy Outcomes
Adverse pregnancy outcomes that may be caused by medications include the following:1,17,18
Birth defects
Infant death
Low birth weight
Miscarriage
Neonatal abstinence syndrome (also called NAS)
Preterm birth
Stillbirth
Sudden unexpected infant death (also called SUID)
The specificity of the medication, dose, stage of embryonic development, genotypes of the mother and fetus, drug interactions, and other environmental or morphological factors affect the teratogenicity of medications.11 Pharmacists recognize teratogenic drugs and can provide recommendations for alternative therapies.4
Pharmacists should review and discuss each medication’s pregnancy safety with patients seeking counseling. Specifically, pharmacists need to identify potentially teratogenic medications and review risks in detail. Patients taking teratogenic medications need to understand reliable contraception’s importance. Healthcare providers should collaborate with patients desiring pregnancy who are taking teratogenic medications to adjust medications before contraception discontinuation. Providers need to guide transitioning to safer medications.3 Table 2 provides a list of medications associated with adverse pregnancy outcomes and recommendations for effective PC.1,33,34,35
Table 2
Selected Adverse Pregnancy Outcomes and
Effective Preconception Care1,33-36
| Medication (Preconception Risk) | Recommendations to Reduce Adverse Outcomes in Pregnancy |
| Antiepileptics | Some are teratogenic; consider lower doses of the current regimen |
| Isotretinoin | Avoid this medication; it can result in miscarriages or birth defects |
| Levothyroxine | Close monitoring and titration for the appropriate neurologic development of the fetus |
| Oral anticoagulants | Avoid exposure during early pregnancy, and change to a nonteratogenic medication |
Pregnancy Registries and Research Studies
The 21st Century Cures Act established a Task Force for the National Institutes of Health called Pregnant Women and Lactating Women (PRGLAC). They advised the Secretary of Health and Human Services on gaps in knowledge and research regarding safe and effective therapies for pregnant and lactating women, and completed their work in 2021.37 The recommendations’ underlying theme was to include pregnant and lactating women in clinical research by removing them from the list of vulnerable populations.38 PRGLAC also recommended removing regulatory barriers to research in pregnant women and optimizing registries with a user-friendly website for listings.38
Patients can volunteer to enroll in a pregnancy exposure registry to help healthcare providers and other pregnant patients. Registries collect information to learn more about prescription medication (and vaccination) safety.28 Pregnancy exposure registries may include patients who have not taken a researched medication. Registries also collect information about newborns after birth.39
Patient Resource: Patients can find a list of pregnancy exposure registries at the FDA’s List of Pregnancy Exposure Registries: https://www.fda.gov/consumers/pregnancy-exposure-registries/list-pregnancy-exposure-registries |
Pharmacy staff should encourage patients to report problems with their medications. FDA MedWatch gathers information about unexpected side effects or adverse events, product quality problems, preventable product use or medication errors, and therapeutic failures. Options for reporting problems include calling a 1-800 number to request a form by mail or completing it online.28
Research studies collect information about medication safety during pregnancy. Patients who choose to join a study will continue their current medications and will not change any part of their health routine.40
Takeaway: Patients can submit their interest in joining a study at MotherToBaby, a service of the non-profit Organization of Teratology Information Specialists (OTIS), at the following link:25 https://mothertobaby.org/join-a-study-form/ or by calling (877) 311-8972. Question: Who would you encourage to join a pregnancy exposure registry or research study? |
Chronic Conditions Requiring Medication
Women who have chronic conditions will often continue to need treatment while pregnant and lactating. Such patients have limited therapy options. Pharmacists are available to manage chronic conditions and recommend alternatives.4 Examples of health conditions managed during pregnancy include the following:40
Asthma
Depression
Epilepsy
Heart disease
Infectious diseases
Pain
Thyroid disorders
Pregnant patients experience anatomical, physiological, and hemodynamic changes.11 Additionally, hormone-mediated and immune response changes may affect medication pharmacokinetics and pharmacodynamics. Studies focused on pharmacology and on specific conditions during pregnancy, along with associated physiological changes, are lacking. Providers need evidence-based guidelines to optimize treatment during each trimester.11
Ideally, pharmacists should counsel patients with diabetes mellitus about disease control before pregnancy. Uncontrolled diabetes increases the risk of congenital anomalies.5 Counseling includes discussion about optimal weight management, glucose monitoring, regular exercise, alcohol and tobacco cessation, and available social support.5 Providers should screen women for thyroid disease and initiate appropriate therapy.5 Prior to pregnancy, patients with epilepsy should consider anticonvulsant discontinuation or consider an alternative treatment.5
Potentially, asthma may worsen with pregnancy. Medication management and counseling patients to avoid triggers are important to control asthma.5 Before becoming pregnant, patients with hypertension should consider changing their regimen to avoid adverse fetal effects. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers are contraindicated in pregnancy.5
Pregnancy-related Ailments
Nausea and Vomiting
A common condition associated with pregnancy is nausea and vomiting. Although nausea and vomiting present no harm to the fetus, they can affect the patient’s ability to work or participate in everyday activities. Safe treatment options are available to improve symptoms and prevent them from worsening.41
Non-pharmacological interventions include eating dry toast or crackers before getting out of bed in the morning, eating five or six small meals daily to avoid an empty stomach, and eating frequent bites of nuts or fruits.41 Patients for whom these changes are unsuccessful may consider medication. Initially, patients should try vitamin B6 (available over the counter (OTC)) for nausea and vomiting in pregnancy. If symptoms persist after trying vitamin B6, patients can add doxylamine (an OTC sleep aid) to their treatment. Alternatively, a prescription medication combining vitamin B6 and doxylamine is available and is safe and effective without fetal harm.41 Lastly, patients who failed other treatment options can take antiemetics.41
Although some antiemetics are safe during pregnancy, safety information is conflicting or limited.41 The European Medicines Agency recommends avoiding ondansetron in the first trimester based on findings from large epidemiological studies showing a small increased risk of oral clefts.42,43 Conversely, a meta-analysis found no significant association with major congenital malformations.44 The decision to take any medication during pregnancy is based on whether the benefits outweigh the potential risks.41
Patients commonly choose OTC antihistamines, such as diphenhydramine, during pregnancy to treat nausea and vomiting and to relieve allergy symptoms (e.g., an itchy or runny nose, sneezing, watery eyes). The National Birth Defects Prevention Study examined 54 antihistamines and identified more birth-defect phenotypes than previously reported. The study has found no association between birth defects and antihistamine use.45 Meclizine is another antinauseant option. Patients can take meclizine 25 mg orally every four to six hours as needed. Although the results of human studies regarding the association between meclizine and fetal facial clefts are mixed, three large trials found no association with teratogenicity.46-48 Another safe antiemetic agent is promethazine, when administered orally or rectally, 12.5 to 25 mg every four hours.49
Constipation
Factors responsible for causing constipation in pregnancy are as follows:50
Hormonal changes (progesterone)
Inadequate hydration
Insufficient fiber intake
Lack of physical activity
Medications (e.g., iron, calcium)
Stress
Unbalanced diet
Patients can adjust their nutrition intake and aim for 25 to 30 grams of fiber by consuming 4 to 5 cups of fresh fruits and vegetables daily.50 Patients struggling to reach their daily fiber goals may consider taking fiber supplements, such as psyllium or methylcellulose (a bulk-forming laxative).50,51 Additionally, staying hydrated by drinking plenty of water is helpful. Patients should engage in moderate exercise for 150 minutes per week.50
Beyond lifestyle changes to modifiable factors, there are medications patients can safely use during pregnancy for constipation. Prescription and OTC medications are available treatment choices.50
Over-the-counter medications may introduce small risks.51 Medications indicated for constipation include osmotic and stool softener laxatives, lubricants, and stimulants. The intestine absorbs osmotic laxatives minimally, so exposure in the developing infant is expected to be low.51 Laxatives cause food to move through the intestines more quickly and may reduce nutrient absorption, possibly leading to nutrient deficiencies.51 Magnesium hydroxide and polyethylene glycol are available OTC, and sodium bisphosphate and lactulose are prescriptions.51 Fetal exposure to docusate sodium (a stool softener) is small since very little medication reaches the patient’s bloodstream. According to available information, docusate sodium is unlikely to increase the chance of birth defects when used as directed.52 Other OTC medications—stimulants (e.g., senna, bisacodyl, and castor oil) and lubricants (e.g., mineral oil)—may cause severe stomach cramps, and patients should use them with caution.51 Patients should be aware that castor oil may cause bowel and uterine cramping. Toward the end of pregnancy, patients need to discuss using castor oil with their providers because it may induce labor. This is not a concern earlier in pregnancy when the cervix is not ready for labor.51
Prucalopride is a prescription medication used to treat chronic idiopathic constipation (happening for at least 6 months) with ongoing pregnancy exposure monitoring.53,54 This medication has a pregnancy exposure registry; however, available case reports are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes. Thus, patients may want to save this option as a last resort if possible.53 Notably, patients taking prucalopride excrete this medication in breast milk. Data on the effects on the infant or milk supply is lacking.53
Pain
Back pain is a common problem in pregnancy.55 Stretching abdominal muscles, hormone changes, and the growing uterus contribute to back pain. Patients should wear supportive clothing, like an abdominal support garment, and low-heeled shoes with good arch support (e.g., athletic or walking shoes).55 Pharmacists should refer patients with severe back pain or pain lasting more than two weeks to their obstetrician-gynecologist to rule out other causes.55
Pharmacy staff can assist patients who are pregnant patients with back pain in choosing a suitable pain reliever. Technicians can alert the pharmacist that a patient needs an OTC recommendation. Pharmacists should advise patients who are pregnant patients to avoid using nonsteroidal anti-inflammatory drugs (NSAIDs) during their last trimester (after 28 weeks) since they can cause serious infant blood flow problems. Taking aspirin may cause bleeding problems in the mother or infant during pregnancy or delivery.56
The ACOG has always identified acetaminophen as one of the only safe pain relievers during pregnancy. Studies have shown unclear evidence proving a direct relationship between acetaminophen during any trimester and fetal developmental issues.57,58 However, pharmacists should recommend acetaminophen with caution. Recent experimental and epidemiological research suggests prenatal exposure to acetaminophen may alter development and increase the risk of neurodevelopmental, reproductive, and urogenital disorders. A consensus statement published in the journal Nature Reviews Endocrinology recommends minimizing use whenever possible.59
Drugs in Breast Milk
Infants’ medication exposure and associated risks continue after birth during breastfeeding.11 Primarily, pharmacists’ roles in medication management are to prevent or lower the risk of adverse effects in infants through transferred medication in breast milk.12 Since few large clinical trials enroll breastfeeding women, pharmacists often have limited data to work with, like case-control studies or animal studies .11
Through passive diffusion, medications pass from maternal plasma into maternal milk.60 More drugs penetrate milk during the first week postpartum.11 Drug-specific factors affect the amount of drug entering the mother’s milk supply. Table 3 lists those factors.11
Table 3 Factors allowing maternal medication transfer11 | ||||
| Factor | Alveolar cells | Drugs’ degree of protein binding | Drugs’ molecular weight | Placental thickness |
| Transfer during lactation | Unswollen | Low | Low | N/A |
| Transfer during pregnancy | N/A | Low | Low | Thicker |
Patients may manage or treat minor ailments with OTC medications and rely on their pharmacy for recommendations. Pharmacists should not make any recommendations regarding medication use without evidence demonstrating safety in breast milk. Safety is important; however, overcautious recommendations may compromise breastfeeding women’s health by leaving conditions untreated.61 Pharmacists’ hesitancy to offer recommendations may result in premature infant weaning or medication non-adherence.62 “When in doubt, don’t breastfeed” is a misconception regarding medication use while breastfeeding. Often referred to as “pump and dump,” women pump to collect breastmilk and then discard it to prevent infant drug exposure. In most situations, this is an unnecessary practice. Brief disruptions in breastfeeding result in substantial negative effects on the infant and the mother’s milk supply.12
Partnering with patients and engaging them in shared decision-making is important in reproductive healthcare. Patients are more likely to participate in their care when healthcare providers include them in the conversation about their treatment options. Shared decision-making involves multiple stakeholder perspectives (e.g., patient, provider, nurse-midwife, lactation consultant, and pharmacist). Patients’ decisions are sensitive to their concerns, needs, and preferences. They are also lifestyle-dependent. Personalized patient care improves patient experience.63
Lactation-related Ailments
Circumnavigating the involvement of a healthcare professional, patients may self-diagnose and purchase OTC medications. Commonly sought information includes directions for use, efficacy, and methods to minimize transfer into breast milk.64
Women who are breastfeeding may be concerned about insufficient milk production, leading to inadequate infant nutrition.62 They are highly susceptible to developing health problems, including breast redness and engorgement.62 The La Leche League recommends nursing or expressing milk at least every 2 hours, using ice (20 minutes on, then 20 minutes off), and taking a hot shower to help engorgement.65 Pharmacists can also recommend medication for the pain. LactMed recommends acetaminophen or ibuprofen for analgesia since the amount of drug in milk is much less than the doses given to infants.20,66
Women who are breastfeeding may also be concerned about contraception options and medication transfer to their breastfed infant.61 LactMed reports that progesterone is not harmful to milk production or nursing duration. The amount of progesterone ingested by the infant (through breastmilk) is small and not expected to cause adverse effects.67
Learning More
Patients can access trusted resources to learn about medication safety during pregnancy or lactation. Pharmacy staff should remind patients to consider their source of information before making any choices. Pharmacies can suggest websites from Table 4 to steer patients in the right direction.28,40,68-71
Table 4 Trusted Resources for Patients28,40,68-71 | |
| Resource | Website |
| Centers for Disease Control and Prevention | cdc.gov/pregnancy/meds/treatingfortwo |
| LactMed | ncbi.nlm.nih.gov/books/NBK501922/ |
| March of Dimes | marchofdimes.org |
| MotherToBaby | Mothertobaby.org |
| Office on Women’s Health, U.S. Department of Health and Human Services | womenshealth.gov |
| U.S. Food and Drug Administration | fda.gov/consumers/womens-health-topics/medicine-and-pregnancy |
Summary
Patients who are pregnant or lactating are concerned with their health and their infant’s health. Partnering with patients and engaging them in shared decision-making is important in reproductive healthcare. Patients are more likely to participate in their care when healthcare providers include them in the conversation about their treatment options. Pharmacists can assist patients in choosing safe medications and balance their need for therapy with any risks. Trusted resources are available to research medication safety and to guide treatment recommendations.
References
Centers for Disease Control and Prevention (CDC). Recommendations to improve preconception health and health care—United States: a report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Surveill Summ 2006; 55: 1–22.
Stanhope KK, Kramer MR. Association Between Recommended Preconception Health Behaviors and Screenings and Improvements in Cardiometabolic Outcomes of Pregnancy. Prev Chronic Dis. 2021;18:E06. Published 2021 Jan 21. doi:10.5888/pcd18.200481
ACOG Committee Opinion No. 762: Prepregnancy Counseling. Obstet Gynecol. 2019;133(1):e78-e89. doi:10.1097/AOG.0000000000003013
DiPietro Mager NA. Fulfilling an Unmet Need: Roles for Clinical Pharmacists in Preconception Care. Pharmacotherapy. 2016;36(2):141-151. doi:10.1002/phar.1691
Jack BW, Atrash H, Coonrod DV, Moos MK, O'Donnell J, Johnson K. The clinical content of preconception care: an overview and preparation of this supplement. Am J Obstet Gynecol. 2008;199(6 Suppl 2):S266-S279. doi:10.1016/j.ajog.2008.07.067
Power to Decide. One key question online. Powertodecide.org. Updated 2024. Accessed April 14, 2024. https://powertodecide.org/what-we-do/information/resource-library/one-key-question-online
Preconception Health and Healthcare Initiative. Preconception clinical toolkit. Beforeandbeyond.org. Published 2014. Accessed May 1, 2024. https://beforeandbeyond.org/toolkit/desires-pregnancy/at-your-fingertips/
McGuire S. Institute of Medicine (IOM) Early Childhood Obesity Prevention Policies. Washington, DC: The National Academies Press; 2011. Adv Nutr. 2012;3(1):56-57. doi:10.3945/an.111.001347
Meek JY, Noble L; Section on Breastfeeding. Policy Statement: Breastfeeding and the Use of Human Milk. Pediatrics. 2022;150(1):e2022057988. doi:10.1542/peds.2022-057988
World Health Organization (WHO). Infant and young child feeding. Who.int. Published December 20, 2023. Accessed April 23, 2024. https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding
Griffin BL, Stone RH, El-Ibiary SY, et al. Guide for Drug Selection During Pregnancy and Lactation: What Pharmacists Need to Know for Current Practice. Ann Pharmacother. 2018;52(8):810-818. doi:10.1177/1060028018764447
Byerley EM, Perryman DC, Dykhuizen SN, Haak JR, Grindeland CJ, Muzzy Williamson JD. Breastfeeding and the Pharmacist's Role in Maternal Medication Management: Identifying Barriers and the Need for Continuing Education. J Pediatr Pharmacol Ther. 2022;27(2):102-108. doi:10.5863/1551-6776-27.2.108
Haddrill R, Jones GL, Mitchell CA, Anumba DO. Understanding delayed access to antenatal care: a qualitative interview study. BMC Pregnancy Childbirth. 2014;14:207. Published 2014 Jun 16. doi:10.1186/1471-2393-14-207
Leeming D, Marshall J, Hinsliff S. Self-conscious emotions and breastfeeding support: A focused synthesis of UK qualitative research. Matern Child Nutr. 2022;18(1):e13270. doi:10.1111/mcn.13270
U.S. Food and Drug Administration (FDA). Pregnant? Breastfeeding? FDA Aims to Improve Drug Information. Fda.gov. Updated November 1, 2023. Accessed March 26, 2024. https://www.fda.gov/consumers/consumer-updates/pregnant-breastfeeding-fda-aims-improve-drug-information
Acebutolol. In: Briggs Drugs in Pharmacy and Lactation. Wolters Kluwer. Updated June 2, 2002. Accessed May 14, 2024.
Acebutolol. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; August 16, 2021.
Erythromycin. In: Briggs Drugs in Pharmacy and Lactation. Wolters Kluwer. Updated May 23, 2022. Accessed May 14, 2024.
Erythromycin. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; April 1, 2019.
Acetaminophen. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; February 15, 2024.
Caffeine. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; January 15, 2024.
Bacitracin. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; May 1, 2019.
Dexchlorpheniramine. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; September 20, 2021.
Caffeine. In: Briggs Drugs in Pharmacy and Lactation. Wolters Kluwer. Updated May 23, 2022. Accessed May 14, 2024.
Acetaminophen. In: Briggs Drugs in Pharmacy and Lactation. Wolters Kluwer. Updated June 2, 2022. Accessed May 14, 2024.
Bacitracin. In: Briggs Drugs in Pharmacy and Lactation. Wolters Kluwer. Updated May 23, 2022. Accessed May 14, 2024.
Dexchlorpheniramine. In: Briggs Drugs in Pharmacy and Lactation. Wolters Kluwer. Updated May 23, 2022. Accessed May 14, 2024.
U.S. Food and Drug Administration (FDA). Medicine and pregnancy. Fda.gov. Updated 10/20/2023. Accessed April 23, 2024. https://www.fda.gov/consumers/womens-health-topics/medicine-and-pregnancy
Temming LA, Cahill AG, Riley LE. Clinical management of medications in pregnancy and lactation. Am J Obstet Gynecol. 2016;214(6):698-702. doi:10.1016/j.ajog.2016.01.187
U.S. Food and Drug Administration (FDA). Pregnancy and lactation labeling (drugs) final rule. Fda.gov. Updated March 5, 2021. Accessed April 14, 2024. https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs-final-rule
March of Dimes. Prescription medicine during pregnancy. Marchofdimes.org. Last Reviewed July 2022. Accessed April 14, 2024. https://www.marchofdimes.org/find-support/topics/pregnancy/prescription-medicine-during-pregnancy
Centers for Disease Control and Prevention (CDC). About SUID and SIDS. Cdc.gov. Updated November 9, 2023. Accessed April 29, 2024. https://www.cdc.gov/sids/about/index.htm
Centers for Disease Control and Prevention (CDC). Accutane-exposed pregnancies--California, 1999. MMWR Morb Mortal Wkly Rep. 2000;49(2):28-31.
Crawford P, Appleton R, Betts T, Duncan J, Guthrie E, Morrow J. Best practice guidelines for the management of women with epilepsy. The Women with Epilepsy Guidelines Development Group. Seizure. 1999;8(4):201-217. doi:10.1053/seiz.1999.0295
Garber JR, Cobin RH, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association [published correction appears in Endocr Pract. 2013 Jan-Feb;19(1):175]. Endocr Pract. 2012;18(6):988-1028. doi:10.4158/EP12280.GL
Korevaar TIM, Leung AM, Alexander EK, et al. American Thyroid Association 2026 Guidelines for Thyroid Disease in Preconception, Pregnancy, and Postpartum. Thyroid. 2026;36(5):481-544. doi:10.1177/10507256261445624
National Institutes of Health (NIH). Task force on research specific to pregnant women and lactating women (PRGLAC) (2017-2021). Nichd.nih.gov. Reviewed November 11, 2023. Accessed April 29, 2024. https://www.nichd.nih.gov/about/advisory/PRGLAC
National Institutes of Health (NIH). List of recommendations from the task force on research specific to pregnant women and lactating women (PRGLAC). Nichd.nih.gov. Reviewed June 7, 2019. Accessed April 29, 2024. https://www.nichd.nih.gov/about/advisory/PRGLAC/recommendations
U.S. Food and Drug Administration (FDA). Pregnancy exposure registries. Fda.gov. Updated December 1, 2023. Accessed April 14, 2024. https://www.fda.gov/consumers/womens-health-topics/pregnancy-exposure-registries
Centers for Disease Control and Prevention (CDC). Facts about medicine and pregnancy. Cdc.gov. Last Reviewed August 7, 2023. Accessed April 14, 2024. https://www.cdc.gov/pregnancy/meds/treatingfortwo/facts.html
The American College of Obstetricians and Gynecologists (ACOG). Morning sickness: nausea and vomiting of pregnancy. Last reviewed October 2023. Accessed April 14, 2024. https://www.acog.org/womens-health/faqs/morning-sickness-nausea-and-vomiting-of-pregnancy
Nelson-Piercy C, Dean C, Shehmar M, et al. The Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum (Green-top Guideline No. 69). BJOG. 2024;131(7):e1-e30. doi:10.1111/1471-0528.17739
Huybrechts KF, Hernández-Díaz S, Straub L, et al. Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring. JAMA. 2018;320(23):2429-2437. doi:10.1001/jama.2018.18307
Picot C, Berard A, Grenet G, Ripoche E, Cucherat M, Cottin J. Risk of malformation after ondansetron in pregnancy: An updated systematic review and meta-analysis. Birth Defects Res. 2020;112(13):996-1013. doi:10.1002/bdr2.1705
Gilboa SM, Strickland MJ, Olshan AF, Werler MM, Correa A; National Birth Defects Prevention Study. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol. 2009;85(2):137-150. doi:10.1002/bdra.20513
Yerushalmy J, Milkovich L. Evaluation of the teratogenic effect of meclizine in man. Am J Obstet Gynecol. 1965;93(4):553-562. doi:10.1016/0002-9378(65)90515-6
Milkovich L, van den Berg BJ. An evaluation of the teratogenicity of certain antinauseant drugs. Am J Obstet Gynecol. 1976;125(2):244-248. doi:10.1016/0002-9378(76)90601-3
Shapiro S, Kaufman DW, Rosenberg L, et al. Meclizine in pregnancy in relation to congenital malformations. Br Med J. 1978;1(6111):483. doi:10.1136/bmj.1.6111.483
Braude D, Crandall C. Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008;15(3):209-215. doi:10.1111/j.1553-2712.2008.00060.x
MotherToBaby. Navigating constipation during pregnancy: a comprehensive guide. Mothertobaby.org. Updated January 25, 2024. Accessed April 22, 2024. https://mothertobaby.org/baby-blog/navigating-constipation-during-pregnancy-a-comprehensive-guide/
MotherToBaby. Laxatives. Mothertobaby.org. Published November 1, 2022. Accessed April 22, 2024. https://mothertobaby.org/fact-sheets/laxatives/
MotherToBaby. Docusate sodium. Mothertobaby.org. Published February 1, 2023. Accessed April 22, 2024. https://mothertobaby.org/fact-sheets/docusate-sodium-pregnancy/pdf/
Motegrity. Prescribing information. Takeda Pharmaceuticals U.S.A., Inc; 2020.
MotherToBaby. Prucalopride (Motegrity®). Mothertobaby.org Published May 1, 2023. Accessed April 22, 2024. https://mothertobaby.org/fact-sheets/prucalopride-motegrity/
The American College of Obstetricians and Gynecologists (ACOG). Back pain during pregnancy. Acog.org. Published May 2020. Accessed April 29, 2024. https://www.acog.org/womens-health/faqs/back-pain-during-pregnancy
Office on Women’s Health (OWH). Pregnancy and medicines. Womenshealth.gov. Updated February 22, 2021. Accessed April 14, 2024. https://www.womenshealth.gov/a-z-topics/pregnancy-and-medicines
Servey J, Chang J. Over-the-Counter Medications in Pregnancy [published correction appears in Am Fam Physician. 2015 Sep 1;92 (5):332]. Am Fam Physician. 2014;90(8):548-555.
American College of Obstetricians and Gynecologists (ACOG). ACOG response to consensus statement on paracetamol use during pregnancy. Published September 29, 2021. Accessed May
Bauer AZ, Swan SH, Kriebel D, et al. Paracetamol use during pregnancy - a call for precautionary action. Nat Rev Endocrinol. 2021;17(12):757-766. doi:10.1038/s41574-021-00553-7
Burkey BW, Holmes AP. Evaluating medication use in pregnancy and lactation: what every pharmacist should know. J Pediatr Pharmacol Ther. 2013;18(3):247-258. doi:10.5863/1551-6776-18.3.247
Sim TF, Hattingh HL, Sherriff J, Tee LBG. The use of non-prescription medicines during lactation: A qualitative study of community pharmacists' attitudes and perspectives. Res Social Adm Pharm. 2018;14(5):464-470. doi:10.1016/j.sapharm.2017.06.002
Saadeh A, Jaradat R, Jarab AS, Saadeh N. Assessment of Jordanian community pharmacists' confidence to provide health services and advice on self-medication for women during pregnancy and breastfeeding. Int J Pharm Pract. 2023;31(2):183-189. doi:10.1093/ijpp/riad003
Meier S, Kasting ML, Liu SS, DeMaria AL. Shared decision-making among non-physician healthcare professionals: Enhancing patient involvement in women's reproductive health in community healthcare settings. Patient Educ Couns. 2021;104(9):2304-2316. doi:10.1016/j.pec.2021.02.032
Sim TF, Hattingh HL, Sherriff J, Tee LBG. Towards the implementation of breastfeeding-related health services in community pharmacies: Pharmacists' perspectives. Res Social Adm Pharm. 2017;13(5):980-988. doi:10.1016/j.sapharm.2017.03.005
La Leche League International. Breastfeeding info engorgement. Llli.org. Published January 2018. Accessed May 1, 2024. https://llli.org/breastfeeding-info/engorgement/
Ibuprofen. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; November 15, 2023.
Progesterone. In: Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; April 15, 2024.
Drugs and Lactation Database (LactMed®). Bethesda (MD): National Institute of Child Health and Human Development; February 15, 2024.
March of Dimes. Marchofdimes.org. Updated 2024. Accessed April 14, 2024. https://www.Marchofdimes.org.
MotherToBaby. Mothertobaby.org. Updated January 25, 2024. Accessed April 22, 2024. https://mothertobaby.org
Office on Women’s Health (OWH). U.S. Department of Health and Human Services. Womenshealth.gov. Updated 2024. Accessed April 14, 2024. https://www.womenshealth.gov
DISCLAIMER
The information provided in this course is general in nature, and it is designed solely to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.
Healthcare professionals must consult their employer, healthcare facility, hospital, or other organization for guidelines, protocols, and procedures to follow. The information provided in this course does not replace those guidelines, protocols, and procedures, but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.
Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses is constantly changing. Any person taking this course understands that such a person must make an independent review of medication information before any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.
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