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Complete Summary

GUIDELINE TITLE

Use of antidepressants in nursing mothers.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

Academy of Breastfeeding Medicine protocols expire five years from the date of publication. Evidence-based revisions are made within five years or sooner if there are significant changes in evidence.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

  • Newborn/infant health and nutrition
  • Postpartum depression

GUIDELINE CATEGORY

Counseling
Evaluation
Management
Prevention
Risk Assessment
Screening
Treatment

CLINICAL SPECIALTY

Family Practice
Nursing
Nutrition
Obstetrics and Gynecology
Pediatrics
Psychiatry

INTENDED USERS

Advanced Practice Nurses
Allied Health Personnel
Dietitians
Nurses
Physician Assistants
Physicians

GUIDELINE OBJECTIVE(S)

To provide recommendations for screening, diagnosis, management and treatment of postpartum depression in nursing mothers

Note: The guideline developers recognize that this is a complex issue, and that there are many other factors that impact the care of women with postpartum depression, but which are beyond the scope of this protocol to discuss.

TARGET POPULATION

Nursing mothers and their newborn infants

INTERVENTIONS AND PRACTICES CONSIDERED

Screening/Diagnosis

  1. Identification of postpartum depression
  2. Use of validated screening tools (Edinburgh Postnatal  Depression Scale, Postpartum Depression Screening Scale)
  3. Ask mothers about:
    • Anxiety
    • Worries, fears
    • Concerns
    • Sleeping problems
    • Weight loss or gain
    • Difficulty breastfeeding
  4. Observe mother-baby interactions
  5. Differentiate between postpartum depression and "baby blues"

Evaluation/Risk Assessment

  1. Assessment of symptoms and clinical history
  2. Assessment of risks and benefits of:
    • Pharmacologic treatment of depression
    • Breastfeeding
    • Untreated depression
    • Medications to infants
  3. Choosing an antidepressant during breastfeeding
  4. Assessment of infants prior to pharmacologic treatment of mother

Management/Treatment

  1. Psychotherapy
  2. Pharmacologic treatment of depression, if indicated
    • Selective serotonin reuptake inhibitors
    • Selective serotonin and norepinephrine reuptake inhibitors
    • Tricyclic antidepressants/heterocyclics
    • Combination therapy
  3. Monitoring of response to treatment
  4. Patient education regarding risks and benefits of treatment

MAJOR OUTCOMES CONSIDERED

  • Detection of postpartum depression
  • Clinical response to pharmacologic treatment
  • Side effects of pharmacologic treatment to mother or infant
  • Infant growth

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

An initial search of relevant published articles written in English in the past 20 years in the fields of medicine, psychiatry, psychology, and basic biological science is undertaken for a particular topic. Once the articles are gathered, the papers are evaluated for scientific accuracy and significance.

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Levels of Evidence

I Evidence obtained from at least one properly randomized controlled trial

II-1 Evidence obtained from well-designed controlled trials without randomization

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

III Opinions of respected authorities, based on clinical experience, descriptive studies and case reports; or reports of expert committees

METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

An expert panel is identified and appointed to develop a draft protocol using evidence based methodology. An annotated bibliography (literature review), including salient gaps in the literature, are submitted by the expert panel to the Protocol Committee.

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

External Peer Review
Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Draft protocol is peer reviewed by individuals outside of lead author/expert panel, including specific review for international applicability. Protocol Committee's sub-group of international experts recommends appropriate international reviewers. Chair (co-chairs) institutes and facilitates process.  Reviews submitted to committee Chair (co-chairs).

Draft protocol is submitted to The Academy of Breastfeeding Medicine (ABM) Board for review and approval. Comments for revision will be accepted for three weeks following submission. Chair (co-chairs) and protocol author(s) amends protocol as needed.

Following all revisions, protocol has final review by original author(s) to make final suggestions and ascertain whether to maintain lead authorship.

Final protocol is submitted to the Board of Directors of ABM for approval.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Clinical Approach to Identifying Postpartum Depression

Postpartum depression is often missed by providers and mothers (Chaudron et al., 2004; Bagedahl-Strindlund & Monsen, 1998; Morris-Rush, Freda & Bernstein, 2003; Heneghan et al., 2000). The symptoms of depression—depressed mood, sleep disruption, weight loss, fatigue, difficulty concentrating, anxiety, loss of interest in usual activities— can be difficult for mothers and providers to distinguish from the normal experiences of new mothers. It is also important to differentiate mothers suffering from postpartum depression from those with postpartum blues as misdiagnosis of such mothers can lead to unnecessary treatment. To distinguish symptoms of depression from the "baby blues," the timing (>2 weeks in duration, all day nearly every day) and the severity (functional impairment) must be evaluated (American Psychiatric Association, 2000).

For many women, acknowledgement of feelings other than happiness following the birth of their infant can be devastating and embarrassing. If mothers have thoughts of harming themselves or their infant, they are often afraid to bring these issues to their obstetrician, family physician, pediatrician, midwife, child health nurse, or other healthcare professional for fear that they will be labeled "crazy" or that their children will be taken away. Therefore, many women will not bring up their concerns or even identify them as a problem unless providers ask specific questions or use a screening tool (see Table 1 below).

Table 1. Recommendations for Identifying Women with Postpartum Depression

  • The preferred method for identifying women with postpartum depression is the systematic use of a validated screening tool such as the Edinburgh Postnatal Depression Scale (Cox, Holden & Sagovsky, 1987) or the Postpartum Depression Screening Scale (Beck & Gable, 2000; Beck & Gable, "Comparative analysis," 2001; Beck & Gable, "Further validation," 2001) at the obstetrical postpartum visit and at well childcare visits in the postpartum year.
  • Ask mothers if they feel down or anxious. Many women with postpartum depression report anxiety as a primary symptom rather than depressed mood or anhedonia. Excessive worrying about the baby's or mother's health should be explored.
  • Ask mothers if they are having trouble sleeping even when they are exhausted and their child is sleeping (Chaudron et al., 2001) or if they are sleeping all the time and are unable to get out of bed.
  • Ask mothers if they are losing or gaining weight. Many women with postpartum depression report a poor appetite, but they eat because they need to keep their strength up or for nursing. Some mothers will gain weight.
  • Ask mothers directly but in an open, nonthreatening manner about thoughts or fears of harming their children. For example, "Many new mothers experience anxiety about their new infants. They may have thoughts that are unusual or frighten them such as fears that they may harm their baby. Does this ever happen to you?" (Wisner et al., 1999) Mothers who experience intrusive thoughts do not wish to harm their children and avoid the topics of their fears (i.e., a mother is afraid her baby will drown therefore will not bathe the baby and has her partner bathe the infant). It is important to distinguish the woman with postpartum depression whose intrusive thoughts or fears of harming the infant are incongruent with the mother's wish to keep her infant safe from the woman with postpartum psychosis who is delusional and who may have thoughts of harming her infant to "save the infant from the devil or a life of torment." Delusional mothers are at great risk of harming their infants or themselves and must be immediately evaluated by a psychiatrist (Spinelli, 2001).
  • Ask mothers if they have concerns or questions about adapting to a new baby.
  • Consider the mother's interactions with the infant, including the responsiveness of mom and baby.
  • Difficulty in breastfeeding, or not enjoying breastfeeding, may be a warning sign that should be further evaluated.

Clinical Approach to Treating Postpartum Depression

Once a woman is identified as suffering from postpartum depression, the choice of treatment must be considered. While no treatment is an option, it is not the preferred approach. Postpartum depression may last for months to years and can have long-term effects for the health and well-being of mothers and infants (Murray et al., 1996; Murray et al., 1999; Murray et al., 2003; Sinclair & Murray, 1998). In breastfeeding women with mild to moderate depression, the first-line treatment, if available, is psychotherapy. Psychotherapy can be an effective treatment for women with postpartum depression and carries no risks for the infants. Psychotherapy may also have the benefit of providing lasting changes in coping skills and adaptation to the new role of motherhood.

If psychotherapy is unavailable or unacceptable to the mother, or the symptoms are severe, antidepressants are an effective option. The approach to choosing an antidepressant is based on a variety of factors. No antidepressant is proven safer or more effective than another in the postpartum period or during lactation. The majority of drugs including all antidepressants are excreted in breastmilk. Data to inform clinical decisions are derived primarily from case reports or case series. Therefore, the initial treatment choice should be based on an informed clinical approach that takes into account the patient's previous treatments for depression, the targeted symptoms, family history of depression and their experiences with antidepressants, current and past medical disorders, current medications, allergies, side effects of the medications, and maternal wishes. An individualized risk-benefit analysis of the treatments must be conducted (see Table 2 in the original guideline document) (Burt et al., 2001).

Clinical Factors Affecting Antidepressant Choice

  • There is no algorithm for antidepressant treatment choices in postpartum or lactating women; however, articles by experts in the field provide clinical guidance (Burt et al., 2001; Hendrick, Burt & Altshuler, 1996).
  • Obtain a history of previous antidepressant treatment. In general, if a treatment was effective in the past and was tolerated, and there are no current contraindications, it is the likely first choice of treatment.
  • Obtain a family history of treatment of depression. An immediate family member's history may be indicative of the mother's treatment response.
  • Consider the primary symptoms that the medication will be targeting and the potential side effect profile of the antidepressant. For example, if the mother is particularly anxious, a medication that might heighten anxiety would not be the first choice. If the mother is experiencing hypersomnia, a medication with sedation as a side effect would not be the first choice. If a mother has somatic complaints such as nausea or diarrhea, a medication that may induce diarrhea would not be the first-line treatment.

Choosing an Antidepressant during Breastfeeding

When considering the use of any medication in a lactating woman, providers must consider the factors that influence infant serum levels, the most accurate measure of infant exposure. Factors affecting the passage of medication into breastmilk must be considered (route of administration, absorption rate, half-life and peak serum time, dissociation constant, volume of distribution, molecular size, degree of ionization, pH of plasma [7.4] and milk [6.8], solubility of the drug in water and in lipids, greater binding to plasma protein than to milk protein), factors affecting the amount of drug received by the infant (milk yield, colostrum vs. mature milk, concentration of the drug in the milk, how well the breast was emptied during the previous feeding), and an infant's ability to absorb, detoxify, and excrete the drug. Up-to-date information about medication use during lactation is available on TOXNET lactmed at http://toxnet.nlm.nih.gov. For information on specific antidepressants (i.e., selective serotonin reuptake inhibitors (SSRIs), selective serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)/heterocyclics) and herbal alternatives used to treat postpartum depression in women, see the original guideline document.

Recommendations for Antidepressant Treatment in Lactating Women

  • Current evidence suggests that the risks of untreated maternal depression can have serious and long-term effects on mothers and infants and that treatment may improve outcomes for mothers and infants. Therefore, treatment is strongly preferred.
  • However, it is important not to label mothers who are only suffering from mild cases of "baby blues" as "depressed." We must make a distinction. If symptoms are mild, there is no reason to initiate antidepressant medication treatment in the first 2 weeks postpartum.
  • When available and when symptoms are in the mild–moderate range, psychotherapy is the first line of treatment for lactating women as it carries no known risk for the infant. Mothers must be monitored and reevaluated. If they are not improving or their symptoms are worsening, antidepressant drug treatment must be considered.
  • Psychotherapy in addition to antidepressant medication is recommended for women with severe symptoms.
  • Women with moderate to severe symptoms may request only antidepressant drug treatment, and this must be considered as the benefits of treatment likely outweigh the risks of the medication to the mother or infant.
  • There is no widely accepted algorithm for antidepressant medication treatment of depression in lactating women. An individualized risk-benefit analysis must be conducted in each situation and take into account the mother's clinical history and response to treatment, the risks of untreated depression, the risks and benefits of breastfeeding, the benefits of treatment, the known and unknown risks of the medication to the infant, and the mother's wishes.
  • If a mother has no history of antidepressant treatments, an antidepressant, such as paroxetine or sertraline, that has evidence of lower levels in breastmilk and infant serum and few side effects is an appropriate first choice.
  • If mothers have been successfully treated with a particular SSRI, TCA, or SNRI in the past, the data regarding this particular antidepressant should be reviewed, and it should be considered as a first-line treatment if there are no contraindications.
  • Mothers should be provided the information regarding the known and unknown risks and benefits of the treatment to make an informed decision.
  • Mothers should be monitored carefully in the initial stages of treatment for changes in symptoms, including worsening of symptoms. Specifically, women with histories of bipolar disorder, which may be undiagnosed, are at increased risk of developing a mood episode of depression, mania, or psychosis in the postpartum period. While this is rare, mothers and partners should be made aware of the symptoms to watch for such as increased insomnia, delusions, hallucinations, racing thoughts, and talking/moving fast and contact their mental health provider immediately.
  • Infants should be evaluated prior to the initiation of a new medication during breastfeeding and monitored carefully by the pediatrician, including carefully following growth. Serum levels are not indicated on a regular basis without a clinical indication or concern.
  • Strategies that may be used to decrease infant exposure, but for which there is little evidence, include medication administration immediately after feedings and pumping and discarding the breastmilk obtained during the peak serum levels.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

REFERENCES SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

The recommendations were based primarily on a comprehensive review of the existing literature. In cases where the literature does not appear conclusive, recommendations were based on the consensus opinion of the group of experts.

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

  • Accurate and timely diagnosis and management of postpartum depression in nursing mothers
  • Appropriate consideration of all treatment options for nursing mothers experiencing depression but who wish to continue breastfeeding

POTENTIAL HARMS

  • Mothers should be monitored carefully in the initial stages of treatment for changes in symptoms, including worsening of symptoms. Specifically, women with histories of bipolar disorder, which may be undiagnosed, are at increased risk of developing a mood episode of depression, mania, or psychosis in the postpartum period. While this is rare, mothers and partners should be made aware of the symptoms to watch for such as increased insomnia, delusions, hallucinations, racing thoughts, and talking/moving fast and contact their mental health provider immediately.
  • Side effects of medications

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

  • Despite many publications of antidepressants and breastfeeding, the scientific literature lacks both the breadth and depth for clinicians and mothers to make confident decisions about individual medications. Multiple reviews of the literature broadly suggest tricyclic antidepressants (TCAs) and serotonin reuptake inhibitors are relatively safe, and all recommend individual risk-benefit assessments.
  • The literature suffers from a lack of any randomized clinical trials in lactating women for any class of antidepressant. The majority of studies are case reports or case series, and most have small samples sizes. Those studies that report larger samples (n ˃ 25) primarily report a variety of medications. Only six controlled studies (one retrospective, five prospective) were found that used a variety of controls—some control for depression, while others do not. None of the studies sufficiently controlled for level of depression. The majority of studies provide information about the amount of medication detected in breastmilk and maternal serum. Some studies also provide information about infant serum levels of medication. Few studies report infant behavioral outcomes.
  • A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

IMPLEMENTATION TOOLS

Foreign Language Translations

For information about availability, see the "Availability of Companion Documents" and "Patient Resources" fields below.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better
Staying Healthy

IOM DOMAIN

Effectiveness
Patient-centeredness
Safety

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2008

GUIDELINE DEVELOPER(S)

Academy of Breastfeeding Medicine - Professional Association

SOURCE(S) OF FUNDING

Academy of Breastfeeding Medicine

A grant from the Maternal and Child Health Bureau, U.S. Department of Health and Human Services

GUIDELINE COMMITTEE

Academy of Breastfeeding Medicine Protocol Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Caroline J. Chantry, MD, FABM, Co-Chairperson; Cynthia R. Howard, MD, MPH, FABM, Co-Chairperson; Ruth A. Lawrence, MD, FABM; Kathleen A. Marinelli, MD, FABM, Co-Chairperson; Nancy G. Powers, MD, FABM

Contributor: *Linda H. Chaudron, MD, MS; *Stephanie A.M. Giannandrea, BA

*Lead authors

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

Academy of Breastfeeding Medicine protocols expire five years from the date of publication. Evidence-based revisions are made within five years or sooner if there are significant changes in evidence.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the Academy of Breastfeeding Medicine Web site.

Print copies: Available from the Academy of Breastfeeding Medicine, 140 Huguenot Street, 3rd floor, New Rochelle, New York 10801.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI Institute on March 23, 2009. The information was verified by the guideline developer on September 10, 2009.

COPYRIGHT STATEMENT

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