Prescription and over-the-counter medication use during pregnancy and lactation is exceedingly common. There are many available resources to gather information and guide patient counseling. These include primary literature, online resources, professional society recommendations, and drug labels. One must consider both disease and drug characteristics when making decisions on medication use during pregnancy and lactation. Providers can then use this information to balance the risks of fetal or neonatal exposure against the potential benefits of maternal treatment and the risks of untreated disease.
Clinical management of medications in pregnancy and lactation
An estimated 94% of women use at least 1 medication while pregnant or lactating, with nearly 70% taking a medication in the first trimester of pregnancy during organogenesis. Many of these medications have not been adequately studied in human pregnancy and have an undetermined risk for birth defects or adverse fetal outcomes. As the prevalence of medication use continues to rise, clinicians in obstetrics and primary care alike face a significant challenge to appropriately counsel patients on the safety and implications of medication use during pregnancy and in the postpartum period.
The importance of this topic was highlighted in a recent workshop on medications in pregnancy and lactation that included representatives from the Society for Maternal-Fetal Medicine (SMFM), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the American Academy of Pediatrics (AAP), and the American College of Obstetricians and Gynecologists (ACOG). This workshop was held concurrently with the annual meeting of SMFM in San Diego, California, on February 3–4, 2015.
The purpose of this document is to highlight our suggested best available resources and to provide a clinical approach for decisions regarding medication use during pregnancy and lactation. This approach incorporates knowledge about the patient’s disease and its impact on pregnancy, both when treated and when untreated; efficacy and safety of treatment options; and potential impact of pregnancy on those treatments.
As a framework for this discussion, imagine receiving a phone call from a long-time patient. She is 30 years old and has a long-standing history of depression that has recently been well controlled on citalopram, and she has just had a positive pregnancy test. The patient wonders if she should stop taking the citalopram. This situation is exceedingly common, as nearly one-third of all pregnant patients are exposed to psychotropic medications. It presents the primary dilemma clinicians face regarding medication use during pregnancy and lactation: the need to balance the risks of fetal or neonatal exposure against the potential benefits of maternal treatment and the risks of untreated disease. Decisions regarding medication cessation, continuation, or dosage adjustments must be shared and can require a multidisciplinary team to design a treatment plan. For psychotropic medications, this typically involves the patient, provider, mental health provider, pediatrician, and available community support services. The case presented here is an example for discussion of available sources of information, but the information discussed could be considered for all medications used during pregnancy and lactation.
Information on medication safety
There are several resources available to providers to evaluate medication safety. We will discuss some of the available electronic resources, the usage and limitations of the drug label, and resources available from ACOG and AAP to provide information about medications. Additional electronic resources available as applications for the iPhone or Android phone, as well as additional telephone-based resources, can be seen in the Table .
| Resource | How to access | Fees associated/availability | Features |
|---|---|---|---|
| Select telephone resources | |||
| Infant Risk Center | 1-806-352-2519 www.infantrisk.com | Free/ M–F 8 am–5 pm CST |
|
| MotherToBaby | 1-866-626-OTIS www.mothertobaby.org | Free, hours vary by state |
|
| Select iPhone and Android applications | |||
| InfantRisk Center | www.infantrisk.com | Application is $9.99 |
|
| REPROTOX | www.reprotox.org | Application is free, requires individual and institutional subscriptions available at a nominal fee, free for those in training |
|
| LactMed | http://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm | Application is free |
|
Primary literature is often a good place to begin the evaluation of any medication used in pregnancy and lactation. This is most commonly accessed via MEDLINE, which is maintained by the National Library of Medicine and is typically searched via PubMed or other platforms, including Ovid, ProQuest, Embase, and Web of Science. Such searches can be limited to human data, clinical trials, or meta-analyses to narrow the scope of the search. Although the method of narrowing a search depends on the platform used, generally one can customize a search by limiting the species to humans and the article types to those suggested above. In PubMed, these customizable options appear on the left side of the search screen. There are cases where the data are less mature in the primary literature and the need for research is ongoing, and this usually becomes evident by performing a search of MEDLINE.
Providers may also consider the use of available online databases with information regarding medication use during pregnancy. One such source is REPROTOX, an online database of summaries regarding drugs and known toxic effects, which is owned by a nonprofit foundation and accessible at www.reprotox.org . Individual and institutional group subscriptions are available at a nominal fee and are generally free for those in training. REPROTOX provides a brief summary of the available primary literature on a medication, and then provides details on available animal and human studies with citations. It also provides details regarding the impact of medication use during lactation for most agents.
For more detailed information on medication use during lactation, providers can access LactMed at http://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm . LactMed is a peer-reviewed, free database that is maintained by the National Library of Medicine and updated monthly. It provides information on medications that may be used during lactation and on drug levels in breast milk and infant blood, and reviews possible adverse effects in nursing infants. Additionally, LactMed reviews the drug effect on milk supply and lactation success. LactMed suggests therapeutic alternatives to drugs that may be harmful and provides summaries, details, and citations of available studies on medications.
Another source of information on medication safety is the drug label. Since 1979, the US Food and Drug Administration (FDA) has provided regulation for drug labeling for pregnancy and lactation, with the use of a categorical system to guide health care providers regarding the risks and benefits of medications. The system consists of 5 letter categories (A, B, C, D, and X), which designate drugs as ranging from no evidence of risk, as demonstrated by adequate and well-controlled studies (A), to animal and human studies showing clear evidence of fetal risk, with the risk of drug use outweighing any possible benefit (X). There is a long history of criticism of the drug labeling system based on the absence of information on the nature, severity, timing, incidence, and treatability of fetal injury, as well as the inclusion of drugs with a wide range of risks in the same category.
In part owing to these concerns, the FDA passed a rule for new labeling requirements starting July 1, 2015. The new label removes the letter-based system and provides information about medications regarding patients in 3 categories: pregnancy, lactation, and females and males of reproductive potential. The label will provide general information, including contact information for a pregnancy registry where available, followed by a fetal risk summary, which details the likelihood that drugs increase the risk of developmental abnormalities. The label also provides specific clinical considerations, including effects of dose, timing, and duration of exposure as well as data from human and animal studies. The label will provide details of any clinical trials and postmarketing data available. The FDA will phase out the old category system. New medications approved after June 2015 are not assigned a safety category, and drugs previously approved after June 30, 2001 have 3 years to submit updated labeling information. Overall, these changes are designed to give information beyond just the category of drug. The new label should encourage providers to use a range of information combined with considerations of risks, benefits, and patient-specific counseling to make decisions regarding medication usage.
There are also resources available from ACOG and the AAP regarding medications in pregnancy and lactation. ACOG has several publications that are available to members via www.acog.org and are otherwise available via MEDLINE. For instance, there are practice bulletins and committee opinions addressing the use of psychiatric, diabetic, analgesic, asthma, thyroid, antihypertensive, and antiemetic medications during pregnancy. These documents provide not only the rationale for using certain drugs and an assessment of the safety data but also a recommendation about use in pregnancy. The AAP recommends the use of the LactMed resource and routinely publishes clinical reports on the transfer of medications into human breast milk. The most recent publication includes information on antidepressants, anxiolytics, antipsychotics, drugs for smoking cessation and substance abuse, diagnostic imaging, vaccines, and herbal products used during lactation. The AAP publications are available via the AAP website or MEDLINE.
Information on medication safety
There are several resources available to providers to evaluate medication safety. We will discuss some of the available electronic resources, the usage and limitations of the drug label, and resources available from ACOG and AAP to provide information about medications. Additional electronic resources available as applications for the iPhone or Android phone, as well as additional telephone-based resources, can be seen in the Table .
| Resource | How to access | Fees associated/availability | Features |
|---|---|---|---|
| Select telephone resources | |||
| Infant Risk Center | 1-806-352-2519 www.infantrisk.com | Free/ M–F 8 am–5 pm CST |
|
| MotherToBaby | 1-866-626-OTIS www.mothertobaby.org | Free, hours vary by state |
|
| Select iPhone and Android applications | |||
| InfantRisk Center | www.infantrisk.com | Application is $9.99 |
|
| REPROTOX | www.reprotox.org | Application is free, requires individual and institutional subscriptions available at a nominal fee, free for those in training |
|
| LactMed | http://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm | Application is free |
|
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