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Medication Safety in Pregnancy: Risks, Research, and What You Need to Know

 


Is Medication Safety in Pregnancy a Myth?

Key Takeaways:

  • Over 90% of pregnant women take at least one prescription medication.

  • Yet, many medications lack sufficient human data on pregnancy risks.

  • Fears of birth defects often lead women to stop their treatment without consulting healthcare providers.

  • Budget cuts threaten future research on medication safety.

  • More studies and better data sharing could improve safety for both mothers and babies.


Understanding Medication Safety in Pregnancy: A Growing Concern

Pregnancy is a time of profound change, and for many women, managing health conditions with the right medications is crucial. In fact, studies show that more than 90% of pregnant women take at least one prescribed drug during their pregnancy. Yet, despite the widespread use of medications, there remains a surprising gap in our understanding of how these drugs affect unborn babies.

Between 2010 and 2019, nearly 300 new drugs were approved, but a staggering 90% of them lacked solid data on the risks they pose during pregnancy. This lack of clarity places both expectant mothers and their healthcare providers in a difficult position, often forcing them to make decisions with limited information.


Why Medication Safety in Pregnancy Remains Uncertain

The uncertainty surrounding medication safety in pregnancy dates back several decades. The infamous thalidomide disaster of the 1950s and 1960s, which caused thousands of birth defects, led to significant changes in drug safety protocols. In response, regulators advised that women of childbearing age be excluded from clinical trials. While this precaution helped protect pregnant women, it also created a major knowledge gap about the impact of medications on pregnancy.

Animal testing, while helpful, doesn’t always replicate human responses. As a result, when a new drug hits the market, there is often little to no data on its effects on pregnancy. Moreover, pharmaceutical companies rarely invest in additional pregnancy trials unless mandated by regulators—meaning that expectant mothers continue to face a lack of solid, reliable data.

A recent study found that roughly 80% of nearly 1,800 medications in use today have limited or no data on birth-defect risks. Researchers estimate that it takes an average of 27 years to collect enough data to confirm a drug's safety for pregnant women. During this time, doctors and patients must make decisions without fully understanding the potential risks.


The Consequences of Stopping Medications During Pregnancy

The fear of harm often drives pregnant women to stop taking medications. A study conducted in the U.S. found that over a third of pregnant women stopped their medication—often without consulting a doctor—due to concerns about birth defects. However, this action can sometimes do more harm than good.

For example, medications used to control seizures are known to have a risk of causing birth defects, yet abruptly stopping these medications can lead to dangerous, uncontrolled seizures—potentially threatening both the mother’s and baby’s lives. Similarly, women with severe depression may experience a relapse if they stop taking antidepressants, which can result in negative health outcomes for both mother and baby.

Managing high blood pressure is another critical issue during pregnancy. Without proper treatment, conditions like preeclampsia can develop, leading to organ damage and insufficient oxygen supply to the fetus. Untreated hypertension can also result in premature birth and poor fetal growth. In such cases, the risks of not taking medication often outweigh the potential harm from the medications themselves.


Funding Gaps Threaten Future Medication Safety Research

Addressing the challenges of medication safety in pregnancy requires sustained research and funding. In 2019, a task force called for increased support to study medication safety in pregnant women. Yet, federal funding has remained stagnant over the years, despite overall increases in the National Institutes of Health (NIH) budget. In 2025, NIH announced cuts to funding, reducing support for new research grants by nearly $5 billion. Proposed budget cuts for the CDC and FDA, two key organizations responsible for tracking medication safety, only add to the uncertainty.

Without adequate funding, it is difficult to conduct long-term studies or expand pregnancy registries that track the effects of medications on pregnant women. While these registries provide valuable data, they often enroll too few participants and typically compare only one drug against a placebo, rather than exploring a broader range of treatment options.


Improving Medication Safety Through Better Research

Despite these challenges, there are signs of progress. Federal agencies and research groups are beginning to create tools that accelerate the gathering of medication safety data for pregnant women. One such initiative is Mother to Baby, a resource that compiles current research on medications and their potential birth-defect risks. This resource helps both expectant mothers and healthcare providers make better-informed decisions.

Following the COVID-19 pandemic, the CDC renewed its commitment to fast-tracking pregnancy safety studies in response to new health threats. The FDA also funded a large-scale study involving nearly 6,000 women to assess the safety of gadolinium, a substance used in MRI scans. The study found no clear risk to the babies of women exposed to the substance during pregnancy.

However, more research is needed, particularly larger, more diverse study groups that can identify rare birth defects. Additionally, comparing different treatment options is vital to understanding what works best for pregnant women. Incorporating privacy protections into studies, especially in light of changing abortion laws, would also help reassure women who may be concerned about legal or social consequences.

Involving pregnant women in the design of these studies is another way to improve research outcomes. When women see that studies respect their needs and values, they are more likely to participate and share accurate information, which ultimately leads to more reliable data.


A Brighter Future for Medication Safety

To ensure the safety of medications used during pregnancy, we need more than just good intentions; we need long-term investment and collaboration. Adequate funding would enable scientists to study both new drugs and long-established medications. It would also support systems that track how medications impact real-world patients over time.

Expectant mothers deserve clear, reliable answers when it comes to continuing essential treatments. Doctors need solid evidence to guide their medical advice. By investing in better research now, we can safeguard both maternal and fetal health, ensuring that the future is healthier for families everywhere.


Frequently Asked Questions (FAQs)

What does medication safety in pregnancy mean?

Medication safety in pregnancy refers to understanding whether a drug poses risks to a developing baby and finding the best way to treat a mother's health condition without causing harm.

How can pregnant women find reliable drug information?

Pregnant women can consult expert resources, such as Mother to Baby, which review the latest research on medications and birth-defect risks. It’s crucial to rely on trusted sources to make informed decisions with healthcare providers.

Why do some women stop their medications when they learn they are pregnant?

Many women fear birth defects associated with certain medications. Without clear data, they may stop treatment, which can sometimes cause more harm to both mother and baby. Always consult with a healthcare provider before discontinuing any treatment.

What can improve future medication safety?

Increased research funding, expanding pregnancy registries, and creating larger, more diverse studies can fill knowledge gaps. Engaging pregnant women in study design and adding privacy protections would also enhance participation and data quality.

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