A panel that was convened in July 2025 by the Food and Drug Administration, led to controversy by giving doubts about the Safety of commonly used antidepressants during pregnancy. But it also brought the broader issue of how little is known about the safety of many medicines used during pregnancy, given the implications for both mother and child – and how too little this subject is.
In the US, the average pregnant patient takes Four prescription medicinesAnd more than 9 in 10 patients take at least one. But most medicines lack convincing evidence about their safety during pregnancy. Over 1 in 5 women Uses a drug during pregnancy that has some provisional evidence that it can cause damage, but for which convincing studies are missing.
We are Researchers in the health of mothers and children that the Security of medicines during pregnancy. In our work we identify medicines that can increase the risk of birth errors or pregnancy loss and compare the safety of various treatments.
Although progress has been slow, researchers and federal agencies have built up monitoring systems, databases and aids to speed up our understanding of medicines. However, these efforts are now in danger Continuous cuts on medical research financing- And with them, the knowledge base is to determine whether it is the safest choice for both mother and child to stick to a therapy or stopping it.
The pregnant women were set aside
A big reason why so little is known about the effects of medicines during pregnancy extends more than half a century. In the sixties, A medicine called thalidomide This was required on a large scale to treat morning sickness in pregnant women, caused serious birth defects in more than 10,000 children around the world. In response, the FDA recommended in 1977 Exception of women of fertile age From participating in clinical studies at an early stage that test new medicines.
From an ethical point of view, there is long -term tension between concerns about fetal damage and mother needs. Legal liability and added complexities when conducting studies in pregnant women serves as Extra barriers for medicines manufacturers.
When medicines are approved, studies are about whether they can cause birth errors usually done only in animalsAnd they often do not translate well into people. So when a new medicine comes on the market, nothing is known about how it influences people during pregnancy. Even if animal studies or the working method of the drug was concerned, the medicine can still be approved, although companies may be needed to carry out studies Observing its effects when it is taken during pregnancy.
Cause and effect
Of 290 medicines approved by the FDA between 2010 and 2019, 90 percent contains no human data About the risks or benefits for pregnant patients. About 80 percent of around 1,800 medicines in one National database called Teriswho summarizes the evidence about the risks of medicines during pregnancy, the lack or limited evidence about the risks for birth defects. Researchers have estimated that it takes 27 years To determine whether a medicine is safe to use during pregnancy.
As a result, much pregnant women stop treating their chronic diseases. Published in an American study in 2023, more than a third of women stopped taking a medicine during pregnancyAnd 36.5 percent of that did this without advice from a healthcare provider. More than half of the concern about birth or development defects as the reason.
Yet uncontrolled chronic diseases with his own toll on both the health of the mother and the baby comes. For example, some medicines used to treat attacks, it is known that they cause birth errors, but stopping it can increase the attacks themselves increase the risk of fetal death.
Women with severe or recurring depression who abruptly stop their antidepressants The risk of their depression that returnsWhat in turn is associated with an increased risk of substance use, insufficient prenatal care and other negative effects on the development of the fetus. Stop the use of drugs for treating high blood pressure Also causes adverse effects-Specific, a greater risk of pregnancy -related high blood pressure that organ damage can cause, called pre -eclampsia; called a condition Placenta -absencewhen the placenta comes off the womb wall too early; premature birth; and fetal growth restriction. An online source with the name Mother to babyMade by a network of experts at birth defects, offers an excellent summary of the available data on medicine safety during pregnancy.
In some cases, the FDA requires pharmaceutical companies to set up registers to follow the results of pregnancies that are exposed to certain medicines. These registers can be useful, but they have shortcomings. Recruiting pregnant patients, for example, takes time and significant efforts, resulting in small sample sizes that may not record rare birth defects. Also, registers usually follow a single medication and rarely contain comparisons with alternative treatment pensions – or not to have treatment.
What is more, following the 2022 Dobbs v. Jackson Women’s Health Organization Supreme Court Decision the constitutional right to abortion, Women can be reluctant To add their names to a pregnancy register or to provide information about prenatal detection of birth defects due to concerns about privacy and legal risks.
Decades of under -financing
In 2019, a Task Force Founded by the 21st -century healings act A large gap identified in knowledge about the safety and effectiveness of drugs in pregnant and reporting women and Recommended a boost in financing To fill it.
However, little has changed. An assessment from 2025 by the National Academies of Sciences, Engineering and Medicine pointed out that research financing for women’s health topics has remained flat over the past decadeWhile the general budget of the National Institutes of Health has increased steadily. The assessment ordered to double the NIH financing assigned to such research, but this seems unlikely in the light of the recent proposals Lower the total NIH budget by 40 percent.
The National Institute of Child Health and Human Development Funds the Most of the research into the safety of medicines during pregnancy About federal agencies, although the institute one considerably smaller budget Then most of his sister institutions such as the National Cancer Institute. The granted grants are usually wide and last four to five years to complete, but they allow the more extensive assessments that are needed to support informed decisions, taking into account the results for mother and child. For example, NIH funded researchers have made a clear link between Autism and prenatal use of ValcateA powerful teratogen that is used to treat epilepsy and various mental disorders.
The Centers for Disease Control and Prevention, as well as the FDA have also specifically financed pregnancy -related research. For example, following the COVID-19 epidemic, The CDC renewed its financing For studies that help accelerate pregnancy safety studies for treatments that can be used for new emerging infections. In response to emerging concerns about a substance called Gadolinium, which is often used during MRI procedures, the FDA has financed our own work A study of nearly 6,000 pregnant womenwhat found no increased risk.
For healthy pregnancies, more research is crucial
These efforts have laid a crucial foundation for evaluating the safety and effectiveness of medicines during pregnancy. But keeping pace with the release of new medicines and new ways they are used, and tackling the backlog of missing evidence that has been approved in the past millennium, remain a challenge.
Recently Terms of studies funded by NIH have focused on topics that probably relate to diversity, fairness and inclusion. But research into Safe and healthy pregnancies and on the health of mothers- for example on the Safety of COVID-19Gaccins while breastfeeding—Deet also affected.
The NIH has reduced new subsidy prices with almost $ 5 billion since the beginning of 2025, and the The chance of receiving NIH financing has plummeted. Proposed sweeping Budget reductions for the CDC and the FDA Leave their role in supporting research into healthy pregnancies that are equally uncertain.
In our opinion, removing or reducing continuous investments in healthy pregnancies is a danger to much needed efforts to reduce Excessive percentages of stillborn as well as infant And mother- deaths.
This article has been re -published from The conversation Under a Creative Commons license. Read the Original article Through Almut WintersteinDistinguished Professor or Pharmaceutical Outcomes & Policy, University of Florida And Sonja RasmussenProfessor of Genetic Medicine, Johns Hopkins University.
Almut Winterstein consults about medication -safety problems with Merck, Syneos, Lykos and Novo Nordisk. She receives financing for pregnancy -related research from NIH, CDC, FDA and the Gates Foundation.
Sonja Rasmussen receives financing from Harmony Biosciences, Axsome Therapeutics, Biohaven (taken over by Pfizer), Lundbeck, Novo Nordisk and Myovant Sciences to serve in scientific advisory committees for pregnancy register. She also receives or has received financing from NIH, CDC and FDA.
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