RxCe - Managing Bipolar Disorder in Childbearing Wome Materials

MANAGING BIPOLAR DISORDER IN CHILDBEARING WOMEN

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. 

Douglas Evans, APRN, PMHNP-BC

Douglas Evans is a board-certified Psychiatric Mental Health Nurse Practitioner. Douglas has over a decade of experience working with adult and adolescent mental health populations in Texas and Montana, respectively. He completed his Master of Science in Nursing (PMHNP) at Midwestern State University. Prior to his graduate degree, he earned an Associate of Applied Science in Nursing degree and a Bachelor of Science in Nursing from Angelo State University.

Anna Shurtleff Smith, MPH, BSN-RN

Anna Shurtleff Smith is a graduate of the University of North Texas Health Science Center, School of Public Health, with a community health focus, and Texas Tech University School of Nursing. She has clinical experience in both inpatient and outpatient settings. Anna is passionate about patient education, health literacy, and health communications.

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

Bipolar disorder is a common and serious psychiatric condition with disabling consequences. Women have the highest risk of being diagnosed with bipolar or having a recurring episode during pregnancy or within one year of giving birth. Sleep deprivation in postpartum women can lead to worsening of the patient's bipolar disorder. In pregnant and postpartum women who are diagnosed with bipolar disorder, lithium is considered the gold standard for the treatment of bipolar disorder. Lithium can be an effective treatment for controlling symptoms. However, fluctuations in serum lithium levels can lead to subtherapeutic levels during the first and second trimesters and supratherapeutic or even toxic levels in the third trimester and postpartum period. In addition, lithium use during pregnancy carries risks. The American College of Obstetricians and Gynecologists issued new guidelines for lithium use during pregnancy and postpartum to address these risks. In cases where lithium is not preferred, other medications may be appropriate. For example, lamotrigine, an anticonvulsant, is widely considered non-teratogenic and is often used as a safe alternative to lithium in pregnancy.

Accreditation Statements

In support of improving patient care, RxCe.com LLC is jointly accredited by the Accreditation Council^TM 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.

This activity was planned by and for the healthcare team, and learners will receive 3 Interprofessional Continuing Education (IPCE) credits for learning and change.

Joint Universal Activity Number: The Joint Accreditation Universal Activity Numbers assigned to this activity are as follows:

Pharmacists: JA4008424-0000-26-059-H01-P

Credits: 3 contact hour(s) (0.3 CEU(s)) of continuing education credit.

Credit Types:

IPCE Credits - 3 Credits

AAPA Category 1 Credit™️ - 3 Credits

AMA PRA Category 1 Credit™️ - 3 Credits

Pharmacy - 3 Credits

Type of Activity: Application

Media: Computer-Based Training (i.e., online courses)

Estimated time to complete activity: 3 contact hour(s) (0.3 CEU(s)), including Activity Pre-Test, Post-Test, and Activity Evaluation.

Release Date: May 1, 2026 Expiration Date: May 1, 2029

Target Audience: This educational activity is for Physicians, Physician Assistants, and Pharmacists

How to Earn Credit: From May 1, 2026, through May 1, 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.)

CME Credit: Credit for this course will be uploaded to CPE Monitor^® for pharmacists. Physicians may receive AMA PRA Category 1 Credit™️ and use these credits toward Maintenance of Certification (MOC) requirements. Physician Assistants may earn AAPA Category 1 CME credit, reportable through PA Portfolio. All learners shall verify their individual licensing board’s specific requirements and eligibility criteria.

Statement of Need

Women with bipolar disorder face an elevated risk of relapse, psychosis, and suicide during pregnancy and the postpartum period. Medication changes are common when pregnancy is discovered. There is an ongoing need for evidence-based assessment and management of lithium in these patients. Suboptimal understanding of pregnancy-related pharmacokinetic changes that can raise or lower lithium levels remains. It is critical to prevent supratherapeutic and subtherapeutic lithium exposure. Approaches to balancing fetal and neonatal risks with maternal stabilization must be undertaken through shared decision-making, ideally with an interprofessional team. Practical guidance is required for healthcare professionals to monitor lab values and related labs, and to adjust, avoid, or continue lithium and other treatment alternatives.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Assess bipolar disorder in women during the peripartum period

Describe the potential risks of lithium use during pregnancy

Describe the fluctuations in serum lithium levels during pregnancy and the postpartum period, leading to subtherapeutic or supratherapeutic lithium levels.

Review the guidelines for lithium use during pregnancy and postpartum.

Describe the lithium laboratory test monitoring in pregnant and postpartum women who are prescribed lithium

Review alternative psychotropic therapies for bipolar disorder in pregnant and postpartum women

Disclosures

The following individuals were involved in planning, developing, and/or authoring this activity: L. Austin Fredrickson, MD, FACP; Douglas Evans, APRN, PMHNP-BC; Anna S. Smith, MPH, BSN-RN; 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.

Educational Activity Pre-Test

Which of the following statements is TRUE about lithium as a treatment for women with bipolar disorder during the peripartum period?

Lithium should only be used by a woman with bipolar disorder during the postpartum period.

Lithium is contraindicated in pregnant women because of the risk of miscarriage.

It is the gold standard for treating women with bipolar disorder during the peripartum period.

Mothers on lithium can breastfeed since the drug is not excreted into breast milk.

Lamotrigine is an anticonvulsant that is FDA-approved for the maintenance treatment of bipolar disorder

and is often used as a safe alternative to lithium in pregnancy.

but it is considered teratogenic and should only be used after delivery.

and for the treatment of acute depression episodes in pregnant women.

but is contraindicated in pregnant women.

Lithium serum levels can become supratherapeutic or even toxic during the third trimester of pregnancy due to

an increased glomerular filtration rate (GFR).

increases in total body water volume.

an increase in intravascular volume.

physiological changes such as hyperemesis gravidarum and dehydration.

Educational Activity

Managing Bipolar Disorder in Childbearing Women

Introduction

Bipolar disorder is a common and serious psychiatric condition that often has disabling consequences for those afflicted by it. Women have the highest risk of being diagnosed with bipolar disorder or having a recurring episode (relapse) during pregnancy or within one year of giving birth. In women with bipolar disorder who become pregnant, medication management is challenging. During the perinatal period, lithium is an effective treatment to control symptoms of bipolar disorder and to prevent a relapse of symptoms. However, there are risks with lithium use during pregnancy for the mother and fetus. The decision to prescribe lithium during pregnancy should be determined by considering the risk factors of using lithium and balancing them with the mother’s risk of mood dysregulation and psychosis. In cases where lithium is not preferred, other medications may be appropriate. This activity will discuss the use of lithium to treat bipolar disorder during the perinatal period, and the available alternative treatments that may also be considered, as well as the need to address sleep deprivation in women during the postpartum period.

Bipolar Disorder in Pregnant Women

Bipolar disorder is a common and serious psychiatric condition that often has disabling consequences for those afflicted by it.^1,2 Bipolar disorder is an affective (mood) disorder characterized by discrete episodes of mania, hypomania, and major depression.³ Some people with bipolar disorder experience psychosis during these mood episodes. Two subtypes exist, namely, bipolar I disorder and bipolar II disorder.³ The problematic symptoms of bipolar disorder often impair a person's ability to function in society and maintain employment and interpersonal relationships. Bipolar disorder is associated with an increased incidence of suicide, violent behaviors, legal problems, comorbid psychiatric conditions, and substance use disorders.^3,4 In the United States, bipolar disorder continues to be a common disabling psychiatric condition that is extremely likely to be accompanied by other disorders.⁴

There is a high risk of a pregnant woman being diagnosed with bipolar disorder during the perinatal period. In fact, there is a significant risk that a woman will experience her first episode of bipolar disorder during pregnancy or postpartum.¹ Sleep deprivation in women during the postpartum period can lead to worsening of the patient's bipolar disorder.² Postpartum women with bipolar disorder are highly vulnerable to experiencing psychosis, mania, depression, and/or mixed episodes.²

Women who are diagnosed with bipolar disorder before becoming pregnant have a 35% rate of relapse of depression or manic episodes during the postpartum period.^2,5 These recurrences vary from mild and moderate to severe, and in the most severe cases, there is even a risk of infanticide and maternal suicide.² In the United States, approximately 700 people die annually from pregnancy-related complications.⁶ Mental health conditions account for nearly 9 percent of these pregnancy-related deaths.⁶ Although suicide attempts and deaths are lower during the perinatal period compared to the general population of women, suicides account for up to 20% of postpartum deaths.^3,5 One study found that in pregnant women with mental health conditions, 63% of the maternal deaths were by suicide.⁶

Screening for Bipolar Disorder

With the high risk of women experiencing their first episode of bipolar disorder during pregnancy or postpartum, screening is an important part of this process. The most common misdiagnosis for bipolar disorder is depression.⁷ Psychiatrists and researchers have found that using the Mood Disorder Questionnaire is a quick (less than 5 minutes) and accurate way to screen patients for potential bipolar disorder.⁸ If a patient shows a positive screening, the patient needs to undergo a comprehensive evaluation for diagnosis.⁷

Lithium as a Treatment for Bipolar Disorder in Childbearing Women

Lithium is approved by the Food and Drug Administration (FDA) as monotherapy for the treatment of bipolar I disorder.^2,9 It is approved for treating acute manic and mixed episodes in individuals aged 7 and older.⁹ It is also approved for maintenance treatment in patients aged 7 and older. It is available in 150 mg, 300 mg, and 600 mg capsules or tablets, as well as in liquid form.⁹

Lithium is considered the “gold standard” for the treatment of bipolar disorder in women during the peripartum period, also called the perinatal period.² This standard is supported by evidence showing that prescribing lithium to pregnant patients diagnosed with bipolar disorder is effective in preventing postpartum mood disorders.^2,10 In addition, among mood-stabilizing medications, lithium has been associated with lower risks of suicide, neuroprotective qualities, and all-cause mortality.^7-9,11,12

Childbearing women with bipolar disorder have a high risk of recurrent episodes in the perinatal period.¹³ Treatment with mood-stabilizing medication during pregnancy might be necessary to reduce this risk.¹³ In patients with a known history of bipolar disorder, lithium is recommended as a prophylactic treatment for bipolar disorder immediately after delivery.^2,5 Lithium can control symptoms of bipolar disorder and can prevent a relapse of symptoms.^2,14-16

Lithium’s efficacy in the peripartum period is well-documented and superior to other mood stabilizers.² For example, a meta-analysis of 37 articles describing 5,700 deliveries in 4,023 patients reported a postpartum relapse risk of 66% in unmedicated women compared with 23% in women with medication, most of whom were on lithium.² Another study of 256 patients, of which 143 used lithium, found that lithium was nearly twice as effective in preventing new mood episodes in pregnant patients as lamotrigine.¹⁷

The primary care physician should discuss the benefits and potential risks of using lithium or other antipsychotics during pregnancy.^2,5 Continuing lithium use during pregnancy requires close monitoring during the perinatal period, including frequent testing of lithium serum levels. Consideration must also be made for mothers who intend to breastfeed.^2,5

Discussing the Risks and Benefits of Lithium Use During Pregnancy

Women with bipolar disorder should coordinate with their healthcare providers prior to conception to weigh the risks, benefits, and evidence-based recommendations for treatment with lithium during pregnancy; however, this is not always feasible because of unplanned pregnancies.¹⁸ Researchers have found a significantly higher rate of unplanned pregnancies among women with bipolar disorder.¹⁹ The rate of unplanned pregnancy was reportedly 50% in women with bipolar disorder, compared to roughly 15% in the control group.²⁰

The risks and benefits associated with lithium use during pregnancy involve comparing the benefits of taking lithium to the risks of discontinuing use of lithium in a woman who was taking lithium prior to pregnancy, teratogenic effects, preterm birth, and miscarriage.

Discontinuing the Use of Lithium

The risks of continuation of lithium during pregnancy should be weighed carefully against the risks associated with discontinuation.^19,20 A collaborative approach between psychiatric and obstetric professionals is needed here.¹⁵ The risk of relapse into a new mood episode is the most concerning potential risk associated with discontinuation of mood-stabilizing medicines.¹⁹ One study found that women who discontinued lithium proximal to pregnancy had an 85% relapse rate of at least one new mood episode.²⁰ Furthermore, the authors found that women who abruptly stopped lithium after learning that they were pregnant had a greater than 50% rate of relapse into a mood episode within 2 weeks.²⁰ Wesseloo, Kamperman, et al. (2016) conducted a meta-analysis of 5,700 deliveries from 4,023 women with bipolar disorder.⁵ The study found a relapse rate of 65% for those who discontinued prophylactic medications, while the rate of relapse was 23% for those who maintained prophylactic medications.⁵

If a patient decides to continue lithium use, the physician and pharmacist must monitor the potential fluctuations in serum lithium levels. The variations that may occur during pregnancy can lead to subtherapeutic or supratherapeutic lithium levels.^21,22 Also, the patient should receive the lowest therapeutic dose based on the patient’s personal history.²²

Teratogenic Risks

Continuing the use of lithium during pregnancy and the perinatal timeline may carry teratogenic risks for the fetus.^15,17,18,23 On this issue, Poels, Kamperman, et al. (2020) reported that lithium is less likely to have adverse effects on the fetus than other drugs used to treat bipolar disorder, such as carbamazepine or valproate.¹³ Nevertheless, childbearing women prescribed lithium to treat a psychiatric disorder need to consider the teratogenic risks lithium may pose to the fetus.^15,17,18,23

For decades, much research has been done on the potentially harmful effects of lithium exposure on fetuses and neonates.¹⁵ The results have varied, but overall, the consensus has been that lithium exposure does increase the risk of cardiac malformations, neurodevelopmental effects, and adverse outcomes;^15,24,25 however, as will be discussed below, there may not be a significant difference in neurodevelopmental functioning for children who were exposed to lithium in utero.

Cardiac Malformations: Ebstein’s Anomaly

In utero exposure to lithium is associated with cardiac malformations, most notably Ebstein’s anomaly. Ebstein’s anomaly is a defect of the tricuspid valve (that separates the right atrium from the right ventricle).¹⁵ Early initial estimates found a 5-fold increase in cardiac defects and a 400-fold increased risk of an Ebstein’s anomaly.¹⁵

A cohort study of more than 1.3 million pregnancies found that among 663 infants exposed to lithium, the adjusted risk ratio was 1.65 for cardiac malformations.¹⁷ In daily doses greater than 900 mg, the risk increased to 3.22.¹⁷ In daily doses between 601 and 900 mg, the risk was 1.60.¹⁷ In daily doses less than 600 mg, the risk decreased to 1.11.¹⁷

However, other studies have found the risk of cardiac malformations to be significantly less.^26,27 After reviewing case studies and retrospective studies, Yacobi and Ornoy (2008) found that the literature was inconclusive and concluded that lithium was not a significant teratogen.²⁶ However, the authors recommend that a fetal echocardiogram be utilized to check for cardiac malformations.²⁶ A 2018 study found that cardiac malformation was not statistically significant for the fetuses of pregnant women exposed to lithium.²⁷ They did find an increased risk of readmission in neonates exposed to lithium, and an increased risk of non-cardiac malformations but cardiac malformations were not statistically significant.²⁷ Finally, Boyle, et al. (2017) reviewed 5.6 million births in 12 countries from 1982 to 2011.¹⁸ They concluded that “the risk of Ebstein’s anomaly rises nearly threefold when the mother is reported to have mental health conditions with medications,” but that the “data suggest that it is not lithium … specifically.”¹⁸

Neurodevelopmental Risks

Poels, Schrijver, et al. (2018) reviewed case reports of eight children with lithium exposure that displayed neurodevelopmental delays.²⁸ However, the authors noted that “most children were reported to have typical neurodevelopmental trajectories.”²⁸ The authors concluded that “there is a paucity of clinical data on the neurodevelopment of children with in utero exposure to lithium. The three clinical studies published in the literature report normal neurodevelopment.”²⁸

Thereafter, a 2022 study also found “no evidence for significantly altered neuropsychological functioning for children exposed to lithium in utero.”²⁹ The study participants were aged 6–14 and were born between 2003 and 2011. These children were the offspring of women diagnosed with bipolar disorder. The study compared children exposed to lithium during the prenatal period to children who had not been exposed. They observed minor differences in neuropsychological functioning, but overall, the study found that the participants’ neurodevelopmental evaluation was within the normal range for lithium-exposed offspring. These findings are consistent with prior studies on this topic.²⁹ This information is important for pharmacists who may be counseling women with bipolar disorder on the use of lithium during the perinatal period.²⁹

Large for Gestational Age

In a retrospective observational cohort study spanning from 1994 to 2018, the authors concluded that lithium use during pregnancy was associated with increased fetal growth parameters at 18–22 weeks of gestational age and increased birth weight.³⁰ In a Swedish population-based cohort study looking at 434 lithium-exposed pregnancies within 854,017 total pregnancies, the authors found that lithium was associated with large for gestational age infants.²⁵ Although the Swedish study did not explore alterations in neonatal blood glucose levels, other researchers have found an association between large gestational age infants and neonatal hypoglycemia.³¹

Adverse Neonatal Events

Exposure to lithium late in pregnancy has been associated with neonatal adaptation syndrome.²³ This syndrome includes hypotonicity (decreased muscle tone), respiratory and feeding difficulties, cardiac arrhythmias, muscle fasciculations (involuntary muscle twitches), lethargy, cyanosis (deoxygenated hemoglobin), and reduced reflexes. The syndrome resolves in 1 to 2 weeks and rarely leads to lasting complications.²³ Low Apgar scores, longer hospitalizations, and neurological complications are associated with lithium concentrations greater than 0.64 mEq/L at delivery. A low Apgar score means the baby needs medical help to adjust outside the womb. Other neonate complications include nontoxic goiter (enlarged thyroid with normal thyroid levels), hypoglycemia, nephrogenic diabetes insipidus (when the kidneys cannot balance body fluids or concentrate urine), and hypothyroidism.²³

Risk of Spontaneous Preterm Birth

Preterm birth is defined as delivery at less than 37 weeks of completed pregnancy and is associated with negative fetal outcomes.³² A 2021 study found a two-fold increase in spontaneous preterm birth in women using lithium during pregnancy, with 35.2 weeks being the median gestational age at birth.²⁵

Risk of Miscarriage

The general rate of miscarriages during pregnancies in the population at large is around 10–15%.¹³ For women with bipolar I disorder who have not been exposed to lithium, the rate is the same. The rate of miscarriage in women exposed to lithium during pregnancy is reportedly twice as high.¹³ The increased risk associated with lithium use does not appear to change when “adjusting for the age at conception, the clustering of pregnancies per woman, and their lifetime use of valproate and carbamazepine.”¹³

Another factor reviewed in this study was the age of onset of bipolar disorder.¹³ Generally, the age of onset indicates how severe the psychiatric condition will be in a patient, but the age of onset was similar for participants regardless of their exposure to lithium. This suggested that illness severity did not play a role in the increase in miscarriages and that lithium use was the cause of the effect.¹³

Overt and subclinical hypothyroidism may be connected with pregnancy loss, and since hypothyroidism may develop during lithium treatment, this may be the mechanism for a miscarriage.^13,36 This study had limitations: it was conducted via questionnaire, and the authors did not have information on each participant’s lithium doses or levels during pregnancy, so they could not assess dose–response relationships. Other factors, such as the mother’s physical condition, weight, and substance use (e.g., alcohol and tobacco), were unavailable.¹³ These limitations did not dissuade the authors from concluding that lithium may increase the risk of miscarriage.¹³

Managing Lithium’s Teratogenic, Miscarriage, and Suicide Risks

There is a potential teratogenic risk associated with lithium use and a higher risk of miscarriage. These risks must be balanced against discontinuing lithium during this time because it can lead to complications in maternal treatment for maternal psychiatric disorders.¹³ In addition, fluctuations in serum lithium levels may occur during pregnancy that can lead to subtherapeutic or supratherapeutic lithium levels. As a consequence, lithium treatment should be carefully managed in childbearing women.^17,22

Managing Teratogenic Risks

Due to concerns about teratogenic effects, women and clinicians may opt to discontinue medications during the perinatal period. If a woman does choose to discontinue lithium during the perinatal period, monitor for the potential risk of a relapse of bipolar disorder symptoms. As integral members of the healthcare team, pharmacists are adept at identifying opportunities for deprescribing with shared decision-making. Although this strategy avoids teratogenic risks, it is not without other significant risks, in particular, relapse into an affective episode.

Some experts recommend the use of up to 4mg of folic acid daily in lithium-treated pregnancies to reduce the risk of cardiac malformation.^33,34
Research suggests that some teratogenic risks may be dose-dependent. One study found that lithium doses greater than 900 mg daily led to a 3-fold risk of cardiac malformations.¹⁷ Similarly, rodent studies of lithium’s teratogenic effects suggest that teratogenicity may be dose-related.^35,36
Lithium exposure during the first trimester has long been established as an increased risk factor for teratogenic effects. Patorno, et al. (2017) found that the risk of cardiac malformation following lithium exposure in the first trimester was four times greater than previously thought.¹⁷ Although not always feasible, reducing or eliminating fetal exposure to lithium during the first trimester could be efficacious in preventing teratogenic effects.
Managing the Risk of Miscarriage
Although the correlation between increased rates of miscarriage and lithium exposure during pregnancy is well-founded, there are no clear recommendations to mitigate the risk aside from the widely established recommendation to limit lithium exposure during the first trimester.¹³

Pre-Pregnancy Therapy Clinical Pearl
Women of child-bearing age taking lithium should be monitored and counseled on potential daily folic acid supplementation.^37,38

Managing Suicide Risks
Acute lithium overdose can occur with suicide attempts. Regular suicide screenings are important for prevention.³⁹

Lithium Pharmacokinetics in the Perinatal Period

The perinatal period is marked by profound physiological changes that influence lithium clearance. This may lead to lithium dropping to subtherapeutic levels or rising to supratherapeutic or toxic levels.

Subtherapeutic Levels

Lithium is renally excreted, and serum lithium levels depend on intravascular volume and glomerular filtration rate (GFR).¹⁷ During pregnancy, plasma volume, total body water, and GFR increase by up to 50%, resulting in a significant decrease in serum lithium levels.¹⁷ This leads to lithium serum levels decreasing by an average of 24% in the first trimester, 36% in the second trimester, and 21% in the third trimester.¹⁷ This notable decrease in serum lithium levels can lead to subtherapeutic levels and the possible relapse into a mood episode.¹⁷ This clearance rate is due to profound physiological changes and increased renal excretion; however, the glomerular filtration rate (GFR) returns to baseline quickly, i.e., by 4 to 9 weeks postpartum.⁴⁰

Although a decline in serum levels is expected during pregnancy, symptoms may worsen in patients whose lithium levels decrease by more than 0.2 mEq/L from baseline and/or fall below the minimal therapeutic level of 0.4 mEq/L; therefore, dose adjustments should be made to maintain a therapeutic serum level.⁴⁰ Postpartum target therapeutic levels of >0.8 mEq/L or 0.8-1.0 mEq/L are recommended for optimal relapse prevention.^15,22

Supratherapeutic or Toxic Levels

Lithium serum levels can also become supratherapeutic or even toxic in the third trimester and postpartum period due to medical conditions that may arise at this time.^15,40 Medical conditions common in pregnancy, including morning sickness, hyperemesis gravidarum (severe nausea and vomiting), dehydration, impaired renal function, and preeclampsia, can increase the likelihood of developing toxic lithium levels.¹⁵

Lithium and Muscle Relaxants

Lithium potentiates succinylcholine, pancuronium bromide, and other muscle relaxants; therefore, care should be taken during the delivery process.⁴¹ Regional anesthesia is considered safe with concurrent lithium use.^15,42

Laboratory Testing and Monitoring

Due to the pharmacokinetic changes associated with pregnancy, serum lithium levels should be checked more frequently during the perinatal period. Drawing trough lithium levels as close as possible to 12 hours after dosing is the established method for measuring serum lithium concentrations.⁴³

Most experts recommend close monitoring of lithium levels and renal function labs – every 3 weeks was suggested – until 34 weeks of pregnancy and then weekly until delivery.¹⁵ More frequent monitoring may be necessary if dehydration, pre-eclampsia, or other illnesses that affect renal function develop.²² Additionally, if lithium dosage adjustments are made, another serum lithium level should be obtained in 1 week.²² Lithium levels should be checked within 24 hours after delivery and up to twice weekly for the first 2 weeks postpartum.^15,22,40 Lithium level, thyroid-stimulating hormone (TSH), and free thyroxine (T4) levels can be obtained from an umbilical cord blood sample.¹⁵

Lithium Clinical Pearl

Lithium requires a trough-level lab draw right BEFORE the next dose, which is typically 12 hours after the last dose.^43,44

Therapeutic plasma concentration levels for postpartum women are 0.8-1.0 mEq/L⁴⁴

Lithium Dosing Adjustments During Pregnancy

Most experts agree that maintaining a therapeutic serum lithium level and symptomological management should dictate the dosing of lithium during the perinatal period while carefully weighing the associated maternal and fetal risks.

The American College of Obstetricians and Gynecologists and other experts recommend that lithium be dosed twice daily during pregnancy to avoid high peak concentrations.³⁴ Sustained-release formulations of lithium could be utilized as alternatives to twice-daily dosing of immediate-release lithium.⁴⁰

The American College of Obstetricians and Gynecologists noted that holding lithium doses at the onset of labor or 24-48 hours before a scheduled birth may reduce the risk of adverse neonatal events.³⁴ Lithium should be resumed on the first evening after delivery if clinically indicated.¹⁵ This is important since the first month postpartum represents a high-risk time for maternal relapse of bipolar disorder symptoms.²

Lithium Adverse Events and Poisoning

Lithium has a relatively narrow therapeutic window, such that a small change in serum lithium concentration can result in subtherapeutic effects, intoxication, or poisoning.^9,45,46 As such, the prescribing information contains a warning for lithium toxicity: “Lithium toxicity is closely related to serum lithium concentrations and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment.”⁹
Lithium use at therapeutic levels can lead to adverse events.^47,48 For example, serum lithium levels >0.8 mEq/l are associated with higher rates of diarrhea.⁴⁷ Lithium use at therapeutic levels can also cause T‐wave depressions and sinus node dysfunction, which is often tied to the duration of lithium treatment; however, these medical events are usually benign and asymptomatic.⁴³ Symptoms from mild to moderate toxic lithium effects may appear at levels as low as 1.5 mEq/L.⁴⁹
At toxic levels, >1.5 mEq/L, lithium “can cause sinoatrial block, intraventricular conduction delay, ST depressions/elevations, the Brugada pattern, atrioventricular conduction delays, QTc prolongation, and changes in the QTdR,” which may cause ventricular instability, cardiac arrhythmias, and sudden cardiac death.⁴³
Unintentional chronic lithium overdose is the most common cause of lithium toxicity.⁴⁵ It is typically due to impaired kidney function from lithium-induced nephrogenic diabetes insipidus or intercurrent illnesses. Additionally, lithium itself can cause damage to the kidneys.^45,50

Lithium can rarely precipitate serotonin syndrome, a potentially life-threatening condition.⁹ The risk is increased with the concomitant use of other serotonergic drugs (including selective serotonin reuptake inhibitors, serotonin, and norepinephrine reuptake inhibitors.⁹ The risk is also increased with triptans, tricyclic antidepressants, fentanyl, tramadol, buspirone, and with drugs that impair the metabolism of serotonin, i.e., MAO Inhibitors.⁹ Serotonin syndrome signs and symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), or autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia).⁹ Neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) may also result from serotonin syndrome.⁹

In the context of a pregnant patient, shifts in fluid balance can lead to increased risks for maternal and infant lithium toxicity.³⁷ For pharmacy staff in a hospital setting, laboratory monitoring can reveal these issues. It is essential that kidney and heart functions be monitored to detect and avoid chronic lithium overdose.
In the event of lithium poisoning, the Extracorporeal Treatments in Poisoning (EXTRIP) Workgroup has developed evidence-based recommendations for the use of extracorporeal treatments for lithium poisoning.⁵⁰ Extracorporeal treatments should be used in patients with severe lithium toxicity.⁵⁰
If poisoning, teratogenicity, or other serious adverse events are identified, confirm that the institutional or practice setting leadership is aware, and consider reporting to MedWatch at this link:⁵¹ https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

Lithium and Breastfeeding

Breastfeeding while on lithium is generally not advisable. Lithium is excreted into breast milk.^13,35,36 Up to one-half of a mother’s lithium levels will be present in breast milk. A breastfeeding infant can ingest approximately one-half of that, which means an infant will take in about one-fourth of the mother’s lithium levels.³⁵ Infants have lower GFR than adults, which increases the risk of infant lithium toxicity.¹³

A mother may decide to stop taking lithium if she wants to breastfeed. This may be an instance where the mother may want to look at alternative medications that can treat her mental health condition and allow her to breastfeed her infant.³⁵

However, not all researchers agree on the topic.^44,52,53 Some researchers have concluded that there is a lack of evidence showing severe negative effects on breastfed infants exposed to lithium.⁴⁴ This suggests lithium could be a viable option for a breastfeeding mother being treated for bipolar disorder.⁴⁴ A Swedish study that monitored the outcomes of 30 infants exposed to lithium through breastmilk concluded that it can be considered safe under strict monitoring.⁵² The authors found that serum lithium levels in the infants were higher than expected during the first few weeks but then stabilized to barely detectable levels.⁵² Poor weight gain was the only adverse effect noted in the study.⁵²

If the mother breastfeeds while taking lithium, it should be done in close collaboration with the infant’s pediatrician.⁵³ The infant’s serum lithium level, renal function, and thyroid function should be monitored during the exposure.⁵³

The American College of Obstetricians and Gynecologists

(ACOG) Guidelines

The American College of Obstetricians and Gynecologists (ACOG) 2023 guidelines on the treatment and management of mental health during pregnancy and the postpartum period include the following recommendations:³⁴

ACOG recommends against discontinuing mood stabilizers, except for valproate, during pregnancy due to the risk of recurrence or exacerbation of mood symptoms.

ACOG recommends that pregnant patients taking lithium in the first trimester receive a detailed ultrasound examination in the second trimester.

It is imperative that lithium dosing be monitored during pregnancy and postpartum.

Alternative Drugs During Pregnancy

Lamotrigine is an anticonvulsant. It is FDA-approved for the maintenance treatment of bipolar disorder, but not for the treatment of acute depression episodes or for peripartum usage. Treatment of acute manic or mixed episodes is not recommended. The effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.⁵⁴ It is widely considered non-teratogenic and is often used as a safe alternative to lithium in pregnancy.^2,55

Wesseloo, Liu, et al. (2017) conducted a cohort study comparing lamotrigine to lithium.⁵⁵ They found that lamotrigine is as effective as lithium for treating severe postpartum episodes; however, this study had a small sample size.⁵⁵ When lamotrigine is used, its pharmacokinetic changes may alter its efficacy, which may require modifying dosing in pregnant patients.^2,55,59

Second-generation antipsychotics are used to treat affective disorders during pregnancy; however, the use of SGAs is controversial in this population group, and more research is needed.^2,52 When used, they are primarily used as adjuvant medications to enhance the effectiveness of a primary drug.^2,52 These include aripiprazole, olanzapine, and quetiapine.^16,57 Nevertheless, SGAs are not universal treatments for all pregnant women with bipolar disorder, and the risk of adverse events associated with these drugs must be considered.^2,52,56,58 Patients with pre-existing metabolic dysfunction should consider aripiprazole rather than quetiapine or olanzapine, which have a higher risk of metabolic adverse effects.²

Valproate is not recommended during any trimester of pregnancy due to the well-established risk of teratogenicity and neurodevelopmental adverse effects.^2,34 Similarly, carbamazepine and oxcarbazepine should be avoided, especially during the first trimester.^2,34

Healthcare professionals and patients should carefully weigh the risks and benefits and make informed decisions when choosing a treatment option.³

Treating Sleep Deprivation

Sleep deprivation in the postpartum period is a significant risk.² Breastfeeding may also contribute to poor sleep.² Sleep deprivation may increase the risk of a postpartum psychosis episode in postpartum patients with bipolar disorder.² Strategies to assist women in ensuring adequate sleep and a stable circadian rhythm during the postpartum period are often essential to treating a patient's bipolar disorder effectively.² Nonpharmacological approaches to treating insomnia should be considered as the first-line treatment option. Cognitive behavior therapy for insomnia (CBT-I) may be effective and can be incorporated into a treatment plan.² Sleep medications, such as benzodiazepines and Z-drugs, are not evidence-based treatments for bipolar disorder, but they are widely used and require complex management during the postpartum period, and close attention to the potential adverse effects these drugs may cause.² Common examples of Z-drugs are zolpidem, eszopiclone, zaleplon, and zopiclone.⁵⁹

Lithium Use During Pregnancy: Case Reports
Case Report I

A 25-year-old pregnant woman was hospitalized due to suspicion of lithium toxicity at 28 weeks gestation.⁶⁰ Serum lithium was 2.1 mEq/L and increased to 5.0 mEq/L over the next 6 hours despite intravenous fluid administration. As the mother underwent hemodialysis, the gynecologist determined that a cesarean section was necessary. The baby had an Apgar score of 2 and died. The autopsy found that the cord blood lithium level was 4.8 mEq/L in an otherwise normally developed baby.⁶⁰ In this case report, we see the potentially devastating consequences of lithium exposure in the perinatal period.⁶⁰

Case Report II

A case report from the Journal of Brazilian Psychiatry demonstrates the importance of considering the risks and benefits of lithium use during pregnancy.⁶¹ In this report, a 32-year-old female of Hispanic ethnicity had an established diagnosis of bipolar I disorder. Reportedly, she had a 9-year history of illness with 4 severe manic episodes, which had led to lengthy hospitalizations. She had been stabilized on 1500 mg daily of lithium.⁶¹

The patient desired to become pregnant. With her psychiatrist, the patient considered the risks and benefits of lithium continuation during pregnancy. Utilizing a decision tree, she and the psychiatrist agreed to continue the lithium throughout the pregnancy. The case concludes with the successful delivery of a healthy baby and the continued psychiatric stability of the patient.⁶¹ This case study highlights the safe and effective use of lithium during pregnancy after careful consideration between a patient and her psychiatrist.⁶¹

Case Report III

A 40-year-old woman with a history of bipolar disorder sought clinical consultation as she was planning a pregnancy.⁶² She had been stabilized on olanzapine and lithium 1200 mg daily for 10 years. After consultation with her psychiatrist, family doctor, and gynecologist, the olanzapine was stopped, and lithium was tapered.⁶² A few months after the lithium taper began, while still on 300 mg daily, she developed a manic episode. Lithium was titrated, and olanzapine was restarted, effectively treating the mania.⁶² In this case report, we see that despite a lengthy period of stabilization, an attempt to discontinue lithium as part of reproductive planning led to a relapse into mania.⁶²

Key Points

There are key points that pharmacists and other clinicians need to consider in women with a diagnosis of bipolar disorder before and during pregnancy, at the time of childbirth, and after the delivery of their newborn child.

Before Pregnancy:

Shared decision-making should weigh the risks and benefits of lithium continuation or discontinuation, and with close collaboration between psychiatric and obstetric services^15,21

Begin folate supplementation^33,34,37,38

During Pregnancy:

Use the lowest effective lithium dosage while maintaining therapeutic serum levels²²

Dosing greater than 900 mg daily has the greatest risk of cardiac malformations¹⁷

In the 1st and 2nd trimesters, lithium levels decrease (without dose adjustments)^15,40

In the 3rd trimester, lithium levels increase (without dose adjustments)^15,40

Monitor serum lithium levels during pregnancy¹⁵

Monitor fetal cardiac development during pregnancy using fetal echocardiography or ultrasound^17,26

Dehydration secondary to morning sickness and other common conditions of pregnancy can result in rapid, severe increases in serum lithium levels²²

Delivery:

Continue monitoring because shifts in fluid balance have led to increased risks for maternal and infant lithium toxicity^13,48

Withholding lithium for 24-48 hours prior to delivery improves neonatal outcomes³⁴

After Delivery:

Monitor the infant’s serum lithium level, renal function, and thyroid function during the exposure⁵³

Resume preconception dosing if clinically indicated¹⁵

The first month postpartum represents a high-risk time for maternal relapse²

Breastfeeding while on lithium is generally not recommended^13,35,36

Patient Education:⁹

Emphasize the importance of adherence to prescribed dosing

Emphasize avoiding dose adjustment unless directed by the prescriber

Inform the patient that regular blood draws will be needed

Tell the patients never to double the dose if they miss a dose

Tell the patient to immediately contact the prescriber if diarrhea, vomiting, tremor, lack of muscle coordination, drowsiness, abnormal heart rhythm, or muscular weakness occurs

Inform the patient of the importance of maintaining a normal diet, staying hydrated, and not changing their intake of salt without telling the prescriber

Advise the patient NOT to start or stop any medicines while taking lithium without talking to the healthcare provider first

Keep a list of medicines to show the healthcare provider and pharmacist when prescribing or purchasing any new medicine

Summary

Lithium has been an effective treatment for bipolar disorder for more than 70 years. The efficacy of lithium in treating mothers during pregnancy and the postpartum period has been confirmed: Lithium has been identified as an effective treatment to control symptoms of bipolar disorder and prevent a relapse of symptoms. Childbearing women with bipolar disorder have a high risk of recurrent episodes in the perinatal period. Lithium is one of the medications available to childbearing women with bipolar disorder. Lithium is less likely to have adverse effects on the fetus than other drugs that are used to treat bipolar disorder.

Despite its clinical efficacy and overall safety, the medicinal use of lithium during pregnancy and the perinatal timeline presents serious challenges to clinicians and patients. Continuing the use of lithium during pregnancy and the perinatal timeline may carry teratogenic risks for the fetus, and it may raise the risk of a miscarriage. This means that a woman who is prescribed lithium to treat a psychiatric disorder needs to consider the teratogenic risks lithium may pose to the fetus. She must also consider the risk that continued lithium use during this time may be associated with a higher risk of a miscarriage. Nevertheless, there appears to be no need at this time to alter clinical guidelines for lithium use during pregnancy, but dosing adjustments may need to be made to address the fluctuations in serum lithium levels that can occur during pregnancy.

Women with bipolar disorder should coordinate with their healthcare providers prior to conception in order to weigh the risks, benefits, and evidence-based recommendations for treatment with lithium during pregnancy. Breastfeeding while on lithium is generally not advisable, as lithium is excreted into breast milk. However, some research suggests that breastfeeding while on lithium is safe under close monitoring.

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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.

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