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Guideline Summary NGC-6421
Guideline T itle
Use of psychiatric medications during pregnancy and lactation.
American College of O bstetricians and Gynecologists (ACO G). Use of psychiatric medications during pregnancy andlactation. W ashington (DC): American College of O bstetricians and Gynecologists (ACO G); 2008 Apr. 20 p. (ACO G practicebulletin; no. 92). [245 references] This is the current release of the guideline.
The American College of O bstetricians and Gynecologists (ACO G) reaffirmed the currency of this guideline in 2012.
Psychiatric illnesses during pregnancy and lactation: Anxiety disorders Major depression Bipolar disorder O bstetrics and Gynecology Guideline O bjective(s)
To aid practitioners in making decisions about appropriate obstetric and gynecologic care To present current evidence on the risks and benefits of treatment for certain psychiatric illnesses during pregnancy T arget Population
Pregnant and breastfeeding women with psychiatric illnesses Interventions and Practices Considered
1. Treatment of depression during pregnancy and lactation* Selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, sertraline, citalopram and paroxetine) Tricyclic antidepressants (TCAs) Atypical antidepressants (e.g., bupropion, duloxetine, mirtazapine, nefazodone, venlafaxine) Structured psychotherapy such as interpersonal psychotherapy or cognitive behavioral therapy Electroconvulsive therapy 2. Treatment of bipolar disorders during pregnancy and lactation* Lithium (including close monitoring of lithium levels) Anticonvulsants including valproate, carbamazepine and lamotrigine Prenatal surveillance for congenital anomalies by maternal serum alpha-fetoprotein level testing, fetal echocardiography or a detailed ultrasound examination of the fetal anatomy 3. Treatment of anxiety disorders during pregnancy and lactation* Benzodiazepines (alprazolam, chlordiazepoxide, diazepam) 4. Treatment of schizophrenia during pregnancy and lactation* Atypical antipsychotic medications (e.g., clozapine, olanzapine, risperidone) Typical antipsychotic medications (e.g., haloperidol, thioridazine, chlorpromazine) *Note: Psychotropic medications have potentially teratogenic and adverse neonatal effects. The benefits of their use during pregnancy and
lactation must be balanced against risks. See the "Major Recommendations" section of this summary and the original guideline document for
context.
Major O utcomes Considered
Effectiveness of psychiatric medications during pregnancy and lactation Teratogenic events, perinatal syndromes or neonatal toxicity related to use of psychiatric medications during Postnatal deaths Methods Used to Collect/Select the 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
2008 O riginal Guideline
The MEDLINE database, the Cochrane Library, and the American College of O bstetricians and Gynecologists' (ACO G's) owninternal resources and documents were used to conduct a literature search to locate relevant articles published betweenJanuary 1985 and June 2007. The search was restricted to articles published in the English language. Priority was given toarticles reporting results of original research, although review articles and commentaries also were consulted. Abstracts ofresearch presented at symposia and scientific conferences were not considered adequate for inclusion in this document.
Guidelines published by organizations or institutions such as the National Institutes of Health and the American College ofO bstetricians and Gynecologists were reviewed, and additional studies were located by reviewing bibliographies ofidentified articles.
2012 R eaffirmation
The NCBI database was searched from 2008 to 2012. Committee members conducted a literature search with theassistance from the ACO G Resource Center staff who routinely perform the Practice Bulletin literature searches.
Number of Source Documents
Methods Used to Assess the Q uality and Strength of the Evidence
W eighting According to a Rating Scheme (Scheme Given) R ating Scheme for the Strength of the Evidence
Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services TaskForce.
I Evidence obtained from at least one properly designed 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 also could be regarded as this type of evidence.
III O pinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses Systematic Review Description of the Methods Used to Analyze the Evidence
Methods Used to Formulate the R ecommendations
Description of Methods Used to Formulate the R ecommendations
2008 O riginal Guideline
Analysis of available evidence was given priority in formulating recommendations. W hen reliable research was notavailable, expert opinions from obstetrician-gynecologists were used. See also the "Rating Scheme for the Strength ofRecommendations" field regarding Grade C recommendations.
2012 R eaffirmation
The Committee on Practice Bulletins - O bstetrics met in O ctober 2012 and reaffirmed this document. A committee memberreviewed the document and new literature on the topic. The document was then reviewed by the committee and thecommittee agreed that it is current and accurate.
R ating Scheme for the Strength of the R ecommendations
Based on the highest level of evidence found in the data, recommendations are provided and graded according to thefollowing categories: Level A - Recommendations are based on good and consistent scientific evidence.
Level B - Recommendations are based on limited or inconsistent scientific evidence.
Level C - Recommendations are based primarily on consensus and expert opinion.
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Internal Peer Review Description of Method of Guideline Validation
Practice Bulletins are validated by two internal clinical review panels composed of practicing obstetrician-gynecologistsgeneralists and sub-specialists. The final guidelines are also reviewed and approved by the American College ofO bstetricians and Gynecologists (ACO G) Executive Board.
Major R ecommendations
The grades of evidence (I-III) and levels of recommendations (A-C) are defined at the end of "Major Recommendations." T he follow ing recommendations and conclusions are based on good and consistent scientific evidence (Level A):
Lithium exposure in pregnancy may be associated with a small increase in congenital cardiac malformations, with a risk ratio of 1.2 to 7.7.
Valproate exposure in pregnancy is associated with an increased risk of fetal anomalies, including neural tube defects, fetal valproate syndrome, and long term adverse neurocognitive effects. It should be avoided in pregnancy,if possible, especially during the first trimester.
Carbamazepine exposure in pregnancy is associated with fetal carbamazepine syndrome. It should be avoided in pregnancy, if possible, especially during the first trimester.
Maternal benzodiazepine use shortly before delivery is associated with floppy infant syndrome.
T he follow ing recommendations and conclusions are based on limited or inconsistent scientific evidence (Level B):
Paroxetine use in pregnant women and women planning pregnancy should be avoided, if possible. Fetal echocardiography should be considered for women who are exposed to paroxetine in early pregnancy.
Prenatal benzodiazepine exposure increased the risk of oral cleft, although the absolute risk increased by 0.01%.
Lamotrigine is a potential maintenance therapy option for pregnant women with bipolar disorder because of its protective effects against bipolar depression, general tolerability, and a growing reproductive safety profile relative toalternative mood stabilizers.
Maternal psychiatric illness, if inadequately treated or untreated, may result in poor compliance with prenatal care, inadequate nutrition, exposure to additional medication or herbal remedies, increased alcohol and tobacco use,deficits in mother–infant bonding, and disruptions within the family environment.
T he follow ing recommendations and conclusions are based primarily on consensus and expert opinion (Level C):
W henever possible, multidisciplinary management involving the patient's obstetrician, mental health clinician, primary health care provider, and pediatrician is recommended to facilitate care.
Use of a single medication at a higher dose is favored over the use of multiple medications for the treatment of psychiatric illness during pregnancy.
The physiologic alterations of pregnancy may affect the absorption, distribution, metabolism, and elimination of lithium, and close monitoring of lithium levels during pregnancy and postpartum is recommended.
For women who breastfeed, measuring serum levels in the neonate is not recommended.
Treatment with all selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors or both during pregnancy should be individualized.
Fetal assessment with fetal echocardiogram should be considered in pregnant women exposed to lithium in the first trimester.
Grades of Evidence
I Evidence obtained from at least one properly designed 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 also could be regarded as this type of evidence.
III O pinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.
Levels of R ecommendations
Level A - Recommendations are based on good and consistent scientific evidence.
Level B - Recommendations are based on limited or inconsistent scientific evidence.
Level C - Recommendations are based primarily on consensus and expert opinion.
Evidence Supporting the Recommendations T ype of Evidence Supporting the R ecommendations
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
Benefits/Harms of Implementing the Guideline Recommendations Appropriate clinical management of psychiatric illness during pregnancy and lactation, which incorporates an appraisal ofthe clinical consequence of offspring exposure to medications, the potential effect of untreated maternal psychiatricillness, and the available alternative therapies Advising a pregnant or breastfeeding woman to discontinue medication exchanges the fetal or neonatal risks of medicationexposure for the risks of untreated maternal illness. Maternal psychiatric illness, if inadequately treated or untreated, mayresult in poor compliance with prenatal care, inadequate nutrition, exposure to additional medication or herbal remedies,increased alcohol and tobacco use, deficits in mother–infant bonding, and disruptions within the family environment (seeTable 1 in the original guideline document). All psychotropic medications studied to date cross the placenta (1), arepresent in amniotic fluid (2), and can enter human breast milk (3). For known teratogens, knowledge of gestational age ishelpful in the decision about drug therapy because the major risk of teratogenesis is during embryogenesis (i.e., duringthe third through the eighth week of gestation). The U.S. Food and Drug Administration (FDA) has provided a system forcategorizing individual medications (see Table 2 of the original guideline document), although this system hasconsiderable limitations. Categories of risk for neonates from drugs used while breastfeeding are also shown in Table 2 ofthe original guideline.
See the "Major Recommendations" section of this summary and the original guideline document for a detailed discussion ofrisks associated with psychotropic medication use during pregnancy and lactation.
Refer to Table 2 in the original guideline document for a list of psychotropic drugs that are contraindicated in pregnancyand lactation.
Qualifying Statements Q ualifying Statements
These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practicemay be warranted based on the needs of the individual patient, resources, and limitations unique to the institution or typeof practice.
Implementation of the Guideline Description of Implementation Strategy
An implementation strategy was not provided.
Implementation T ools
Foreign Language Translations Patient Resources For information about availability, see the Availability of Companion Documents and Patient Resources fields below.
Institute of Medicine (IOM) National Healthcare Quality Report Categories IO M Care Need
IO M Domain
Identifying Information and Availability American College of O bstetricians and Gynecologists (ACO G). Use of psychiatric medications during pregnancy andlactation. W ashington (DC): American College of O bstetricians and Gynecologists (ACO G); 2008 Apr. 20 p. (ACO G practicebulletin; no. 92). [245 references] Not applicable: The guideline was not adapted from another source.
Date R eleased
2008 Apr (reaffirmed 2012) American College of O bstetricians and Gynecologists - Medical Specialty Society Source(s) of Funding
American College of O bstetricians and Gynecologists (ACO G) American College of O bstetricians and Gynecologists (ACO G) Committee on Practice Bulletins - O bstetrics Composition of Group T hat Authored the Guideline
Financial Disclosures/Conflicts of Interest
This is the current release of the guideline.
The American College of O bstetricians and Gynecologists (ACO G) reaffirmed the currency of this guideline in 2012.
Electronic copies: None available.
Print copies: Available for purchase from the American College of O bstetricians and Gynecologists (ACO G) DistributionCenter, PO Box 933104, Atlanta, GA 31193-3104; telephone, 800-762-2264, ext. 192; e-mail: . The ACO GBookstore is available online at the .
Availability of Companion Documents
Patient R esources
The following are available: Depression. Atlanta (GA): American College of O bstetricians and Gynecologists (ACO G); 2008. Available from the . Copies are also available in Spanish.
Postpartum depression. Atlanta (GA): American College of O bstetricians and Gynecologists (ACO G); 1999.
Available from the .
Print copies: Available for purchase from the American College of O bstetricians and Gynecologists (ACO G) DistributionCenter, PO Box 933104, Atlanta, GA 31193-3104; telephone, 800-762-2264, ext. 192; e-mail: . The ACO GBookstore is available online at the .
Please note: This patient information is intended to provide health professionals with information to share with their patients to help thembetter understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC toprovide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then toconsult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to theirpersonal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included onNGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not itaccurately reflects the original guideline's content.
NGC Status
This NGC summary was completed by ECRI Institute on July 21, 2008. The information was verified by the guidelinedeveloper on August 11, 2008. This summary was updated by ECRI Institute on May 1, 2009 following the U.S. Food andDrug Administration advisory on antiepileptic drugs. This summary was updated by ECRI Institute on July 20, 2009following the U.S. Food and Drug Administration advisory on Varenicline and Bupropion. This summary was updated byECRI Institute on January 8, 2010 following the U.S. Food and Drug Administration advisory on Valproate sodium. Thissummary was updated by ECRI Institute on March 18, 2010, following the U.S. Food and Drug Administration advisory onZyprexa (olanzapine). This summary was updated by ECRI Institute on September 15, 2010 following the U.S. Food andDrug Administration advisory on Lamictal (lamotrigine). This summary was updated by ECRI Institute on May 20, 2011following the U.S. Food and Drug Administration advisory on antipsychotic drugs. This summary was updated by ECRI Institute on September 12, 2011 following the U.S. Food and Drug Administration advisory on Celexa (citalopramhydrobromide). This summary was updated by ECRI Institute on April 16, 2012 following the updated U.S. Food and DrugAdministration advisory on Celexa (citalopram hydrobromide). This summary was updated by ECRI Institute on July 10,2013 following the U.S. Food and Drug Administration advisory on Valproate. The currency of the guideline was reaffirmedby the developer in 2012 and this summary was updated by ECRI Institute on March 7, 2014.
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines representedon this site.
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