Use of prescription medications potentially harmful during pregnancy among women of reproductive age by pregnancy status and contraceptive use in the United States, 2009–2020

Abstract

Background

Despite recent changes in the labeling of safety risks for prescription medications during pregnancy, information on the use of prescription medications potentially harmful or teratogenic among women of reproductive age is not known. In this study, we examine trends in the use of prescription medications potentially harmful during pregnancy based on pregnancy status and the use of contraceptives in the U.S.

Methods

We conducted a repeated cross-sectional analysis using five cycles of the National Health and Nutrition Examination Survey (NHANES), 2009–2010 through 2017–2020. Our sample included women aged 20–44 years who reported prescription medication use in the past 30 days. Medications were classified using Micromedex into three fetal risk categories: (1) contraindicated during pregnancy, (2) fetal harm has been demonstrated, and (3) may cause fetal harm. We estimated weighted prevalence of any prescription medication use and use of ≥ 1 potentially harmful medication by pregnancy status (pregnant vs. non-pregnant) and contraceptive use among non-pregnant women. Trends were examined overall, by fetal risk severity, therapeutic class, and specific medications.

Results

Among pregnant women aged 20–44 years, the prevalence of any prescription medication use increased from 28.5% to 37.1% (P<0.05) between 2009 and 2014 and 2015–2020, respectively, while no significant change was observed among non-pregnant women, regardless of contraceptive use. Use of at least one potentially harmful medication remained common among pregnant women (14.6% to 14.5%) and among non-pregnant women, including those not using contraceptives (27.4% to 27.1%). Importantly, the use of two or more potentially harmful medications increased among pregnant women from 1.5% to 5.0% (P<0.05). Antidepressants were the most frequently used potentially harmful medications across women of reproductive age; among pregnant women, antidepressant use increased from 2.6% to 7.1% (P = 0.12), driven largely by sertraline use, which increased from 0% to 5.4%.

Conclusions

Prescription medications with potential fetal risk are commonly used among women of reproductive age, including pregnant and non-pregnant women who are not using contraceptives, especially antidepressants. These findings highlight the need for continued monitoring of maternal mental health treatment and increased awareness of medication safety during pregnancy.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1186/s12978-026-02409-7.

Background

Despite potential safety concerns, the use of prescriptions medications during pregnancy in the United States is common [1–6]. National studies showed that a large number of pregnant women take prescription medications to treat both chronic and acute conditions [1–4]. Mansour et al. found that anti-infectives, analgesics, psychotropics, antidiabetics, anti-asthmatics, and levothyroxine are the most commonly dispensed medications during pregnancy by analyzing across three nationally representative or large claims-based datasets [5]. Additionally, Chang et al. reported medication usage stratified by pregnant women and non-pregnant women. The proportion of pregnant women utilizing multiple medications increased from 2.8% in 1999–2000 to 10.0% in 2015-2016 [6]. Even though these studies have investigated the use of potentially harmful medications among pregnant women, no study has compared the exposure to multiple potentially harmful medications between pregnant and non-pregnant women of child-bearing potential simultaneously, further stratified to hormonal contraception use among non-pregnant women. Despite the overall decline in unintended pregnancies, 41.6% of pregnancies in the US are unintended and consequently may expose the unborn to harmful medications [7, 8].

Historically, the U.S. Food and Drug Administration (FDA) used a letter-based categorization system (A, B, C, D, X) to communicate the risks of drugs during pregnancy between 1979 and 2015 [9, 10]. However, this system was widely criticized for misleading clinicians to treat classifications as graded safety levels, and was absent of specific information critical to providers making decisions for their pregnant or lactating patients, or for women of childbearing age. To address this limitation, the FDA introduced the Pregnancy and Lactation Labeling Rule (PLLR) in 2015, eliminating lettered categories and changing to narrative summaries [9, 11]. The PLLR is intended to provide clearer information about known risks and include relevant pregnancy, lactation, and reproductive potential data. However, some clinicians expressed concerns that qualitative risk descriptions are more difficult to interpret and implement than the previous letter system [12]. One study assessed drug labeling for compliance with the PLLR and found that newly approved drugs subject to the PLLR were generally compliant, although human pregnancy data were available for only 10.7% of new drugs. Among drugs approved before full PLLR implementation, 32.6% of drugs approved from 2010 to 2015 had not adopted the new labeling format by 2019 [13]. Also, as Roca noted, PLLR is limited by a fundamental lack of human data, emphasizing the need for additional post-approval safety data to inform drug labels [14].

Research on medication safety in pregnancy has mainly focused on teratogenic medications. Sarayani et al. used claims data to assess teratogenic exposures and found that 1.71% to 4.94% of pregnancies were exposed to definite or potentially teratogenic drugs, depending on the exposure window and risk definition [15]. Winterstein et al. (2024) found that 5.8% of pregnancies with livebirths had prenatal exposure to teratogenic medications during relevant risk windows [16]. However, the scope of these studies excluded the drugs that generally do not cause major congenital malformations but may still be harmful to fetal and postnatal function and development. For example, opioids, benzodiazepines, antidepressants, beta-blockers, hormonal drugs, misoprostol, and methotrexate were excluded from Winterstein’s list of teratogens [17–20].

Given all these circumstances, this study aims to address an under-researched area. By assessing the use of potentially harmful medications among pregnant and non-pregnant women aged 20 to 44 in the United States and evaluating the data based on hormonal contraceptive use, we seek to gain a better understanding of the changes in utilization of potentially harmful medications in women of childbearing potential.

Materials and methods

We utilized data from the National Health and Nutrition Examination Survey (NHANES) from 2009 to 2020, which includes the cross-sectional surveys from the 2009–2010 through 2017–2020 NHANES cycles [21]. NHANES employs a stratified, multistage probability design to provide nationally representative estimates for the U.S. community-dwelling population. The Centers for Disease Control and Prevention (CDC) combined cycles 2017–2018 and 2019–2020 to ensure nationally representative estimates, as NHANES suspended data collection in March 2020 due to the COVID-19 pandemic. The detailed description of the data can be found elsewhere [21].

The analysis sample comprised women of reproductive age (20–44 years) who completed a self-reported pregnancy status questionnaire at the Mobile Examination Center (MEC). And the cutoff of age is because pregnancy status in the NHANES data is reported only for women aged 20–44. During the household interview, information on prescription medications taken within the most recent 30 days was collected. NHANES obtained written informed consent from all participants. This study was exempt from human subjects’ approval by the institutional review board at the University of Southern California.

Using the publicly available NHANES data, we excluded the participants who did not respond to the prescription drug use questionnaire, had undergone hysterectomy, or oophorectomy. We categorized the analysis sample into three groups: pregnant, non-pregnant not using hormonal contraception, and non-pregnant using hormonal contraception.

During the NHANES household interview, participants reported prescription medications taken within the prior 30 days. Medication names were coded and linked by generic names to a proprietary database (Lexicon Plus^®; Cerner Multum, Inc.) of all prescription and some nonprescription medication products available in the U.S. market [22]. Medications were evaluated at the ingredient level.

For this study, we used the Micromedex Pregnancy Risk Category definitions to identify potentially harmful medications for the three groups of women studied. Micromedex^® is a proprietary, evidence-based clinical decision support tool [23]. The Micromedex Pregnancy Risk Categories are determined by independent clinical review of peer-reviewed scientific literature, clinical guidelines, and other primary sources, and include: fetal risk is minimal; fetal risk cannot be ruled out; may cause fetal harm; fetal harm has been demonstrated; and contraindicated [24]. Because these categories differ in evidentiary certainty and clinical implication, we provide a brief interpretation of each category (appendix eTable 1). We further identified medications with a Boxed-Warning for use during pregnancy or where a Risk Evaluation and Mitigation Strategy (REMS) is proposed to prevent fetal exposure. We first utilized hormonal contraceptive (HC) usage to stratify non-pregnant women into hormonal contraception users and non-users. After this stratification, HCs, medications exclusively used for fertility treatments (clomiphene and menotropins), and misoprostol were excluded from the potentially harmful medication exposure outcome. We focused the data analysis on the potentially harmful medication categories of: may cause fetal harm, where fetal harm has been demonstrated, or are contraindicated for use during pregnancy. Use of any medication and potentially harmful medications in pregnancy were categorized as none, any use (≥ 1), and concurrent use (≥ 2).

Descriptive statistics were used to estimate the weighted prevalence of medication use among participants of childbearing age in the prior 30 days for each NHANES cycle examined. We evaluated the changes in commonly used medications that are potentially harmful among pregnant and non-pregnant women, stratified by hormonal contraception use. P values were calculated using logistic regression with survey cycles modeled as a dichotomous variable (2009–2014 vs. 2015–2020). Two-sided P < 0.05 was considered statistically significant. All analyses were conducted using Stata Statistical Software: Release 16 (StataCorp LP) [25].

The study was conducted using publicly available, de-identified data and was therefore exempt from institutional review board approval. Informed consent was obtained by the NHANES and all analyses were conducted in accordance with relevant guidelines.

Results

During the periods 2009 to 2014 and 2015 to 2020, the proportion of pregnant women aged 20–44 in the United States who reported using any prescription medication in the previous 30 days increased from 28.5% to 37.1%, as shown in Fig. 1A. While the prevalence of use of at least one potentially harmful medication remained stable, the prevalence of use of two or more potentially harmful medications increased from 1.5% to 5.0%, as shown in Table 1. According to Fig. 1B, the most significant increase was in the category “fetal risk cannot be ruled out”. In addition, the use of medication in the category “fetal harm has been demonstrated” remained high, around one in ten pregnant women exposed to such medications. Among non-pregnant women who did not report using hormonal contraceptives (HC), the overall prevalence of using any medication remained relatively stable across the two periods, as shown in Fig. 1A. According to Table 1, approximately 37.0% of them reported using any medication, while 27.0% reported using at least one potentially harmful medication, and 12.0% reported use of two or more harmful medications. As shown in Fig. 1B, over one in five used a medication where “fetal harm has been demonstrated”, and nearly 5.0% used a contraindicated medication. Lastly, the changes in using potentially harmful medications were also evident for non-pregnant women who reported using hormonal contraception. Their prevalence of using at least one medication remained stable over time, but the prevalence of using two or more potentially harmful medications increased from 11.1% to 14.3% as shown in Fig. 1A. Importantly, use of contraindicated medications increased significantly from 1.6% to 5.3% (P = 0.03), as shown in Table 1. More than one in five women in this group used medications that are harmful to the fetus.

Fig. 1.

Trends in the use of medications among pregnant and non-pregnant women aged 20-44 years in the U.S., 2009-2020. Abbreviations: HC, hormonal contraceptive. a Data, from the National Health and Nutrition Examination Survey (NHANES), include prevalence estimates weighted to represent medication use among women aged 20 to 44 years. b Potentially harmful medications include contraindicated for use during pregnancy; fetal harm has been demonstrated; may cause fetal harm

Table 1.

Trends in the use of medications among pregnant and non-pregnant women aged 20–44 years in the U.S., 2009–2020

	Weighted Prevalence, %a
			Non-Pregnant
	Pregnant		No HC Use		HC Use
	2009–2014	2015–2020	2009–2014	2015–2020	2009–2014	2015–2020
Overall, Unweighted No.	190	156	3,216	2,591	364	312
Any Medication Use, %	28.5	37.1*	37.5	36.2	40.5	39.6
≥ 1 Harmful Medicationb	14.6	14.5	27.4	27.1	27.9	28.6
Contraindicated	2.9	3.4	4.4	4.7	1.6	5.3 *
Fetal harm has been demonstrated	10.4	11.2	21.3	21.5	21.4	21.4
May cause fetal harm	2.0	3.5	10.4	9.9	11.9	14.0
Fetal risk cannot be ruled out	18.6	22.8	21.8	20.1	20.2	21.8
Fetal risk is minimal	7.1	8.8	5.1	4.8	5.6	10.3
≥ 2 Harmful Medicationsb	1.5	5.0	12.5	11.7	11.1	14.3

Abbreviations: HC hormonal contraceptive

P values indicate statistically significant difference in prevalence between 2009–2014 and 2015–2020; * <0.05

^a Prevalence estimates are weighted to account for differential probabilities of selection and survey nonresponse

^b Harmful medications include: contraindicated, fetal harm has been demonstrated, or may cause fetal harm

Based on hormonal contraceptive (HC) use and the survey period (2009–2014 vs. 2015–2020), weighted prevalence estimates for selected potentially harmful medications reported among pregnant and non-pregnant women indicated that medications frequently used during pregnancy include antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, anti-asthmatics, opioid analgesics, corticosteroids, and hormones. As shown in Table 2, from 2009 to 2014 to 2015–2020 and among pregnant women, the weighted prevalence of opioid analgesics decreased from 4.6% to 1.0%, anti-asthmatics changed from 2.4% to 2.6%, and antidepressants increased from 2.6% to 7.1%. In addition, the weighted prevalence of sertraline, classified by Micromedex under “fetal harm has been demonstrated”, increased to 5.4% in 2015–2020. Metronidazole and hydroxyprogesterone were categorized as “contraindicated for use during pregnancy”; among pregnant women, metronidazole use was observed in 2015–2020 (0.4%), and hydroxyprogesterone use increased from 0.4% to 1.0% (P = 0.51).

Table 2.

Potentially harmful medications used by pregnant and non-pregnant women aged 20–44 years in the U.S., 2009–2020

	Weighted Prevalence, %a
				Non-Pregnant
	Pregnant			No HC Use			HC Use
	2009-14	2015-20	P	2009-14	2015-20	P	2009-14	2015-20	P
Antidepressants	2.6	7.1	0.12	9.8	10.0	0.88	11.7	11.4	0.91
Sertralineb	0	5.4	---	2.4	2.6	0.77	2.3	1.9	0.71
Bupropionb	1.4	0.9	0.71	1.9	1.7	0.62	1.3	4.5	0.10
Citalopramb	---	0.8	---	1.7	1.0	0.08	1.5	2.3	0.44
Paroxetinec, d	0.3	---	---	0.5	0.5	0.91	0.8	0.5	0.70
ASH	1.1	---	---	4.7	4.5	0.79	4.0	3.9	0.98
Alprazolamb	---	---	---	1.4	1.4	0.99	2.4	---	---
Clonazepamb	0.7	---	---	0.9	0.6	0.22	0.3	2.3	0.04
Hydroxyzinec	---	---	---	0.3	0.8	0.02	---	1.2	---
NSAIDs	0.4	0.7	0.55	4.1	4.2	0.90	2.7	4.6	0.27
Ibuprofenb	0.4	0.2	0.75	1.9	2.8	0.05	1.0	1.1	0.79
Diclofenacb	---	0.5	---	0.2	0.2	0.98	0.5	0.2	0.48
Anticonvulsants	0.8	0.8	0.98	2.4	3.2	0.16	1.7	3.9	0.18
Pregabalind	---	---	---	0.2	0.1	0.26	---	0.2	---
Gabapentind	---	---	---	0.5	1.5	0.004	0.1	0.2	0.78
Oxcarbazepineb	---	0.8	---	0.0	0.2	0.06	---	1.6	---
Divalproex Sodiumc, e	---	---	---	0.2	0.3	0.64	0.5	0.7	0.77
Asthma Medications	2.4	2.6	0.91	2.7	2.9	0.84	7.0	6.3	0.75
Montelukastb	1.9	2.3	0.88	0.9	1.3	0.31	2.5	1.5	0.40
Fluticasoned	0.5	0.4	0.85	1.5	1.4	0.64	2.9	3.7	0.63
Salmeterold	---	0.4	---	0.8	0.3	0.05	0.2	---	---
Opioid Analgesicse	4.6	1.0	0.15	5.1	2.7	0.001	2.1	2.7	0.68
Hydrocodoneb, e	1.5	---	---	2.8	1.5	0.03	1.4	0.7	0.39
Tramadolb, e	1.4	1.0	0.82	0.9	0.6	0.30	0.7	0.2	0.36
Codeineb, e	1.1	---	---	0.3	0.3	0.96	---	0.4	---
Oxycodoneb, e	0.7	---	---	1.3	0.5	0.005	---	1.8	---
CNS Stimulants	---	---	---	2.4	2.3	0.86	0.9	5.2	0.02
Dextroamphetamined	---	---	---	1.2	1.1	0.92	0.6	4.2	0.06
Amphetamined	---	---	---	1.2	1.0	0.81	0.6	3.2	0.12
ACE Inhibitorse	---	---	---	2.5	2.2	0.51	1.2	0.6	0.39
Lisinoprilb, e	---	---	---	2.1	2.2	0.84	1.2	0.6	0.39
Benazeprilb, e	---	---	---	0.3	---	---	---	---	---
Corticosteroids	1.3	0.5	0.50	1.1	2.2	0.01	3.5	1.7	0.23
Prednisoneb	0.2	---	---	0.6	1.1	0.14	0.9	0.6	0.67
Budesonided	1.1	---	---	0.1	0.4	0.01	0.3	---	---
Methylprednisoloneb	---	0.5	---	0.1	0.2	0.06	1.2	---	---
Antipsychotics	---	0.9	---	1.1	1.3	0.71	1.2	0.9	0.78
Quetiapined	---	---	---	0.4	0.4	0.91	0.6	0.5	0.84
Lithiumb	---	---	---	0.1	0.3	0.27	0.3	---	---
Risperidoned	---	0.9	---	0.1	0.2	0.93	---	---	---
Anti-infectives	---	0.9	---	1.1	1.1	0.97	0.4	0.5	0.95
Doxycyclined	---	0.5	---	0.6	0.8	0.60	0.1	0.5	0.28
Metronidazolec	---	0.4	---	0.5	0.4	0.75	0.3	---	---
Antineoplastics	---	---	---	0.7	1.3	0.06	0.1	2.9	0.004
Medroxyprogesteronec	---	---	---	0.4	0.5	0.64	---	---	---
Tamoxifenb	---	---	---	0.0	0.3	0.02	---	---	---
Tretinoinb, e	---	---	---	0.2	0.3	0.67	---	0.5	---
Methotrexatec, e	---	---	---	0.0	0.1	0.21	---	1.5	---
Isotretinoinc, e,f	---	---	---	---	---	---	---	0.9	---
Hormones	1.6	1.6	0.98	0.6	1.1	0.22	---	0.6	---
Estradiolc	---	---	---	0.3	0.7	0.37	---	0.6	---
Methimazoled	0.3	---	---	0.1	0.1	0.53	---	---	---
Progesteronec	0.9	0.6	0.73	0.2	0.1	0.67	---	---	---
Hydroxyprogesteronec	0.4	1.0	0.51	---	---	---	---	---	---

Abbreviations: HC hormonal contraceptive, ASH anxiolytics, sedatives, hypnotics, NSAIDs non-steroidal anti-inflammatory drugs, CNS central nervous system, ACE angiotensin-converting enzyme 

P values indicate statistically significant difference in prevalence between 2009–2014 and 2015–2020

^a Prevalence estimates are weighted to account for differential probabilities of selection and survey nonresponse

^b Fetal harm has been demonstrated

^c Contraindicated for use during pregnancy

^d May cause fetal harm

^e Boxed-Warning for fetal harm

^f Risk Evaluation and Mitigation Strategy (REMS) to prevent fetal exposure

Among non-pregnant women not using hormonal contraception, antidepressants had the highest weighted prevalence, and usage remained stable from 9.8% to 10.0% (P = 0.88). Antidepressants were mainly under the category “fetal harm has been demonstrated” or “contraindicated for use during pregnancy”. There was a significant increase in hydroxyzine usage, which is contraindicated for use during pregnancy, from 0.3% to 0.8% (P = 0.02). Gabapentin use increased from 0.5% to 1.5% (P = 0.004). In contrast, there was a decrease in the use of opioid analgesics (P = 0.001), hydrocodone use decreased from 2.8% to 1.5% (P = 0.03), and oxycodone use declined from 1.3% to 0.5% (P = 0.005). Changes in medication classes were generally similar from 2009 to 2014 to 2015–2020 among non-pregnant women reporting the use of hormonal contraception. However, some significant differences in magnitude were observed. Anxiolytics, Sedatives, Hypnotics (ASH) use remained prevalent, with clonazepam increasing from 0.3% to 2.3% (P = 0.04). The prevalence of using Central Nervous System (CNS) stimulants increased significantly from 0.9% to 5.2% (P = 0.02). Dextroamphetamine and amphetamine were all under the category “may cause fetal harm”, and the weighted prevalence increased from 0.6% to 4.2% (P = 0.06) and from 0.6% to 3.2% (P = 0.12), separately.

Discussion

This study provides an up-to-date assessment of potentially harmful medication use among women aged 20 to 44 using the most recent nationally representative data [21]. Despite the increases in quality information drawn from the greater number of prospective international registries [26], online information support [27], and ongoing mitigation efforts, the use of medications with risk to the fetus and adverse pregnancy outcomes remains unacceptably high and is still an important public health problem. We found that about three in twenty pregnant women use at least one potentially harmful medication during pregnancy. In addition, one in ten used a medication that has fetal harm demonstrated. While the trend of using at least one harmful medication remained stable among pregnant women between 2009 and 2014 and 2015–2020, the change in using at least two harmful medications tripled. The greatest increase was in the category “fetal risk cannot be ruled out”, and the use of some contraindicated medications also increased. These findings reflect population-level medication exposure patterns based on established pregnancy risk categories, rather than fetal or neonatal outcomes.

The prevalence and patterns of potentially harmful medication use observed in our study are consistent with previous national studies on prescription use during pregnancy but also extend. Consistent with the findings from Palmsten et al., we found that codeine and hydrocodone are the most common medications, excluding fertility treatments [28]. In addition, Cooper et al. found that the use of antidepressants, especially sertraline, increased significantly [29]; our results aligned with this finding. We discovered that antidepressants are one of the most prevalent exposures with established fetal risk in our study. This is consistent with a recent report identifying antidepressants as the most frequent cause of maternal drug-associated neonatal congenital anomalies using data from the FDA Adverse Event Reporting System [30]. With third trimester use, Selective Serotonin Reuptake Inhibitors (SSRIs), particularly at higher maternal doses, are recognized to cause neonatal adaptation syndrome, featuring central nervous system signs referable to serotonin excess in the newborn [31]. Maternal dose optimization is needed to provide efficacy and avoid postnatal functional complications [32]. Clinicians should consider cumulative risk from concurrently prescribed potentially harmful medications, even when they are not classified as teratogenic.

The persistence of potentially harmful medication use underscores the limitations of the Pregnancy and Lactation Labeling Rule (PLLR). Although PLLR replaced alphabetical pregnancy risk categories with literature-based narratives in 2015, the system remains incomplete with many labels lacking high-quality human pregnancy data. This, and the lack of a patient-specific evidence-based decision support, may enhance communication difficulties of information about the teratogenic and other malformation and functional risks of medications during pregnancy to providers and patients [13, 14]. Therefore, future research should integrate indicators for Boxed-Warnings and teratogenicity into medication risk classifications. For example, Winterstein et al. identified 137 definite teratogenic agents, while Sarayani et al. documented 141 definite teratogens (12 with current or discontinued REMS) and 65 potential teratogens [15, 16]. These lists could be used with population-level utilization data together to refine risk estimates. Numerous maternal therapeutic agents are often omitted from lists assessing fetal risk that confine the focus to teratogenicity. Drugs such as opioids (neonatal abstinence) [33], beta-blockers (intrauterine growth restriction) [34], ergot alkaloids (low birthweight and preterm birth) [35] and SSRIs (as discussed above) that have additional consequences during the second and third trimesters should be retained in the analysis list given the relevance to maternal, fetal, and neonatal health.

However, we recognize some limitations. The cross-sectional measure of self-reported drug use 30 days prior to the survey (with drug names verified during the interview) may underestimate true exposure during pregnancy as some women may have stopped using high-risk medications after realizing they were pregnant or may have been exposed before pregnancy. We were unable to distinguish whether the reported drugs were taken before or after women realized they were pregnant [36–38]. Thus, our “pregnant” group may not adequately represent early pregnancy exposures that ended before the survey, while the “non-pregnant” group may include some very early, undetected pregnancies. However, computing usage based on pharmacy claims data may have similar or greater limitations in this regard. Additionally, maternal dosages of purported higher risk medications were not examined. An increasing number of studies point to maternal dose magnitude as a factor in major congenital malformation and other fetal/neonatal adverse effects (e.g., beta-blockers, antiseizure medications, lithium) [34, 39, 40]. We also did not assess paternal medication exposures before conception that may affect subsequent pregnancy outcomes.

Conclusions

We examined medication usage by non-pregnant women in the United States by hormonal contraception consumption. Among non-pregnant women using hormonal contraception, there is a significant increase in contraindicated medication use; especially concerning for the increase in usage of two or more of these medications. This may reflect patient confidence in the performance of the contraceptive in preventing pregnancy and providing a sense of safety in the use of medications that would otherwise be restricted during pregnancy. This reinforces the need for counseling and close follow-up for all women of childbearing potential regarding their health, contraception and medication use, and recommendations for the safest alternatives when drug therapy is required. We strongly suggest further research focus on subgrouping pregnant women, non-pregnant women not using contraception, and non-pregnant women using contraception when assessing drug use burden and patterns in examining fetal and neonatal categorical risk, and within the development of mitigation and counseling strategies.

Abbreviations

REMS

Risk Evaluation and Mitigation Strategies

FDA

U.S. Food and Drug Administration

PLLR

Pregnancy and Lactation Labeling Rule

NHANES

National Health and Nutrition Examination Survey

CDC

Centers for Disease Control and Prevention

MEC

Mobile Examination Center

HC

Hormonal Contraceptives

NSAIDs

Non-steroidal Anti-inflammatory Drugs

ASH

Anxiolytics, Sedatives, Hypnotics

CNS

Central Nervous System

ACE

Angiotensin-Converting Enzyme

SSRIs

Selective Serotonin Reuptake Inhibitors

Authors’ contributions

Dima M Qato conceptualized the study, Katharine Ozenberger and Qingrong Li conducted the data analysis. Qingrong Li and Katharine Ozenberger drafted the manuscript. Dima Mazen Qato and Irving Steinberg critically revised the manuscript. All authors read and approved the final version.

Funding

This research received no specific funding agency.

Data availability

The datasets analyzed during the current study are publicly available from the National Health and Nutrition Examination Survey (NHANES) conducted by the Centers for Disease Control and Prevention.

Declarations

Ethics approval and consent to participate

The study was conducted using publicly available, de-identified data and was therefore exempt from institutional review board approval. Informed consent was obtained by the NHANES and all analyses were conducted in accordance with relevant guidelines.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.