A panel convened by the Food and Drug Administration (FDA) in July 2025 has raised concerns regarding the safety of commonly used antidepressants during pregnancy. This revelation has highlighted a more significant issue: the alarming lack of safety data on many medications taken by pregnant women. With over 90% of expectant mothers using at least one medication, the implications of this knowledge gap are profound for both maternal and fetal health.
The average pregnant patient in the United States takes approximately four prescription medications, yet most lack conclusive evidence regarding their safety during pregnancy. Research indicates that about one in five women uses medications that may carry risks of harm, but definitive studies proving this are scarce. As researchers specializing in maternal and child health, we focus on evaluating medication safety during pregnancy, identifying potential risks for birth defects, and comparing the safety of various treatments.
Unfortunately, ongoing cuts to medical research funding threaten to undermine these efforts, jeopardizing the essential knowledge needed to determine whether continuing a treatment or discontinuing it is the safest option for mothers and their children.
The Historical Context of Medication Safety in Pregnancy
The roots of this situation can be traced back to the 1960s when the drug thalidomide was prescribed to pregnant women for morning sickness, leading to severe birth defects in over 10,000 children worldwide. In response to this public health crisis, the FDA recommended in 1977 that women of childbearing age be excluded from early-stage clinical trials for new medications.
This exclusion has created a persistent ethical dilemma between the need to protect fetal health and the necessity of addressing maternal health needs. Legal liabilities and the complexities involved in studying pregnant women further hinder drug manufacturers’ willingness to conduct essential research. As a result, drugs approved for use often lack sufficient testing on their effects during pregnancy.
Research shows that of the 290 drugs approved by the FDA between 2010 and 2019, 90% contained no human data on risks or benefits for pregnant patients. Moreover, approximately 80% of the 1,800 medications listed in a national database known as TERIS either lack or have limited evidence regarding their risks for birth defects. This data deficiency contributes to a troubling trend: it can take up to 27 years to confirm whether a medication is safe for use during pregnancy.
Consequently, many pregnant women are forced to discontinue treatment for chronic conditions. A study published in the U.S. in 2023 indicated that over one-third of women stopped taking medications during pregnancy, with 36.5% doing so without consulting a healthcare provider. Concerns about potential birth or developmental defects were cited by more than half of these women as their reason for discontinuation.
Yet, uncontrolled chronic diseases can pose significant risks to both the mother and the unborn child. For example, some medications used to manage seizures are known to cause birth defects, but discontinuing them can lead to increased seizure activity, which raises the risk of fetal death. Similarly, women with severe or recurrent depression who abruptly stop taking antidepressants may face a resurgence of depressive symptoms, which is linked to negative outcomes for fetal development.
The Threat of Research Funding Cuts
Efforts to establish better monitoring systems and databases for studying medication safety during pregnancy have been hampered by persistent underfunding. A 2019 task force created under the 21st Century Cures Act identified significant gaps in knowledge regarding drug safety for pregnant and lactating women and called for increased funding to address these issues. However, a review published in March 2025 by the National Academies of Sciences, Engineering and Medicine revealed that funding for women’s health research has stagnated over the past decade, even as overall budgets for organizations like the National Institutes of Health (NIH) have increased.
Despite recommendations to double NIH funding for women’s health, proposed budget cuts threaten to diminish the already limited resources available for critical research. The National Institute of Child Health and Human Development, which funds much of the research on medication safety during pregnancy, operates with a budget significantly smaller than that of other institutes, such as the National Cancer Institute.
Furthermore, with nearly US$5 billion in new grant awards cut since early 2025, the chances of receiving NIH funding have drastically decreased. Proposed budget cuts to the Centers for Disease Control and Prevention (CDC) and the FDA further jeopardize ongoing research initiatives.
In light of these challenges, the consequences of reducing investments in maternal health are severe. Such cuts endanger efforts to address excessive rates of stillbirths and maternal and infant mortality. The need for comprehensive research on medication safety during pregnancy has never been clearer, particularly in a climate where emerging treatments and medical practices evolve rapidly.
As we navigate these complexities, initiatives like Mother to Baby, which provides detailed summaries of medication safety during pregnancy, remain vital. Additionally, while the FDA has mandated some drug companies to create registries tracking pregnancy outcomes for specific medications, these efforts often yield small sample sizes and limited data that may not capture rare birth defects.
The implications of the 2022 Dobbs v. Jackson Supreme Court decision, which overturned the constitutional right to abortion, have also cast a shadow over research efforts. Women may hesitate to participate in pregnancy registries or share information about prenatal detection of birth defects due to concerns about privacy and legal repercussions.
Moving forward, it is crucial that stakeholders invest in robust research initiatives to ensure that pregnant women receive safe and effective treatments. The health of mothers and their children depends on a commitment to understanding the complexities of medication use during pregnancy and addressing the gaps in knowledge that have persisted for decades.
