Challenges Faced by Pregnant Women Regarding Medication Safety Amid Research Funding Cuts

Recent discussions surrounding the safety of medications for pregnant women have intensified, particularly following a panel convened by the Food and Drug Administration (FDA) in July 2025. This panel raised concerns about the risks associated with commonly prescribed antidepressants during pregnancy, highlighting the broader issue of insufficient research on medication safety for expectant mothers and their children.

In the United States, it is estimated that an average pregnant woman takes four prescription medications, with over 90% using at least one. However, a significant gap exists in the conclusive evidence regarding the safety of these medications during pregnancy. Alarmingly, around one in five pregnant women are prescribed medications that, while potentially harmful, lack comprehensive studies confirming their risks.

Researchers specializing in maternal and child health have been diligently working to assess the safety of various medications during pregnancy. Their studies aim to identify drugs that may increase the risk of birth defects or pregnancy loss. Despite some progress, these efforts are currently threatened by ongoing cuts to medical research funding, jeopardizing the ability to determine the safest medical treatments for pregnant women.

A historical context helps explain the limited knowledge surrounding medication effects during pregnancy. In the 1960s, the prescription of thalidomide for morning sickness led to severe birth defects in thousands of infants. This tragedy prompted the FDA to recommend excluding women of childbearing age from early clinical trials, creating a long-standing ethical dilemma between protecting fetal health and addressing maternal medical needs. The complexities surrounding legal liability further deter drug manufacturers from conducting studies involving pregnant women.

When new drugs are approved, assessments of their potential to cause birth defects are often conducted only on animal models, which do not always correlate with human outcomes. Consequently, many new medications enter the market without any data on their effects during pregnancy. Even when concerns arise from animal studies, drugs can still receive approval, often with a requirement for post-marketing studies to evaluate their effects on pregnant individuals.

Statistics reveal a concerning trend: of the 290 drugs approved by the FDA from 2010 to 2019, a staggering 90% lack human data regarding their risks or benefits for pregnant patients. Furthermore, a significant portion of medications listed in the TERIS (Therapeutic Research in Pregnancy) database show either limited or no evidence regarding their impact on birth defects. Research indicates that it can take decades to ascertain whether a medication is safe for use during pregnancy.

This uncertainty leads many pregnant women to discontinue necessary treatments for chronic conditions. A study conducted in 2023 indicated that over one-third of women ceased their medications during pregnancy, with many doing so without consulting a healthcare provider. Concerns about the potential for birth defects were cited by over half of these women as the primary reason for their decision.

However, the implications of untreated chronic conditions can be severe for both mothers and their babies. For instance, medications prescribed for seizure disorders may pose risks for birth defects, yet the absence of these medications may result in increased seizure activity, which is associated with higher rates of fetal mortality. Similarly, women with severe depression who abruptly stop their antidepressants risk a return of depressive symptoms, which can negatively affect prenatal care and fetal development. Additionally, discontinuing medications for hypertension can lead to complications such as preeclampsia, placental abruption, preterm birth, and restricted fetal growth.

Despite the establishment of pregnancy registries by the FDA to track outcomes for expectant mothers taking specific medications, these registries face significant limitations. The recruitment process for pregnant participants is time-consuming, often resulting in small sample sizes that may not capture rare outcomes. Furthermore, these registries typically focus on single medications without considering alternative treatment options or the absence of treatment.

Recent legal and social dynamics, particularly following the 2022 Supreme Court decision in Dobbs v. Jackson, may further deter women from participating in pregnancy registries due to privacy concerns and potential legal repercussions.

In 2019, a task force emphasized the critical need for increased funding to address the lack of research on drug safety for pregnant and lactating women. Despite these recommendations, funding for women's health research has stagnated over the past decade, even as overall budgets for the National Institutes of Health (NIH) have increased. The current proposal to cut NIH funding by 40% poses additional threats to ongoing research efforts.

The National Institute of Child Health and Human Development serves as the primary source of funding for research on medication safety during pregnancy, yet its budget remains significantly smaller compared to other institutes. Grant applications are often broad in scope and take several years to complete, hindering timely assessments necessary for informed decision-making.

While recent studies have improved our understanding of medication safety during pregnancy, the landscape remains challenging. New medications are continually introduced, and existing medications lack adequate evidence for safe usage during pregnancy. Ongoing reductions in NIH funding and proposed budget cuts for the Centers for Disease Control and Prevention (CDC) and FDA threaten vital research initiatives aimed at ensuring the health of pregnant women and their children.