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Recently, the Trump administration’s announcement connecting Tylenol use during pregnancy to autism in children has sparked renewed debate about how medications are tested for safety and efficacy in pregnant and breastfeeding women.
This group has been traditionally left out of clinical trials due to concerns about the safety of both the mother and the unborn child.
However, healthcare providers specializing in maternal health argue that this exclusion has led to a lack of research on which medications are truly harmful or beneficial during pregnancy.
“Without solid evidence, due to the exclusion of these groups from trials, we often have to rely on theoretical risks based on how a drug might work,” explained Dr. Sindhu Srinivas, an OB-GYN at Penn Medicine. “This leaves us with discussions that aren’t always informed by the best data.”
In recent years, experts in maternal-fetal medicine, obstetrics, pediatrics, mental health, and other fields have advocated for including more pregnant participants in drug trials to build confidence in medication use during pregnancy.
Srinivas emphasized the need to shift from automatically excluding pregnant women from studies to a research culture that protects them through informed participation.
“When considering trial enrollment, it involves a discussion and informed consent with the patient,” she noted. “Pregnant individuals should have the option to participate, just like anyone else, and make their own informed decisions.”
Research Gaps Due to Cautious Trial Exclusion
The exclusion of pregnant women from clinical trials has a long history, primarily driven by fears of potential risks. This caution intensified after incidents like the thalidomide tragedy.
In the 1950s and 1960s, thalidomide was widely used in Europe and Canada as a remedy for morning sickness and insomnia, despite not being tested on pregnant women.
Eventually, it was discovered that the drug caused severe birth defects in thousands of infants, leading to its market withdrawal and increased caution in drug testing for pregnant women.
While regulations have gradually eased some of these restrictions, Srinivas noted that the research on medication use during pregnancy remains limited, often relying on retrospective studies or data registries.
Many women need medications to manage mental health, chronic conditions, and pain, yet they face a cultural narrative suggesting all medication use during pregnancy is harmful.
“For patients with conditions like hypertension or diabetes, not taking medication during pregnancy can be detrimental to both the mother and the baby,” Srinivas explained.
This narrative can lead to feelings of guilt and the false belief that mothers must choose between their health and their child’s, when ideally, both should be prioritized.
“It’s a nuanced conversation about the severity of a condition and the risks of not taking medication,” she said. “It’s not a one-size-fits-all approach; it’s a personalized discussion with each patient.”
Advancing Inclusive Drug Research
Leading medical organizations, including the Society for Maternal and Fetal Medicine and the American College of Obstetricians and Gynecologists, advocate for the inclusion of pregnant and breastfeeding individuals in drug research when appropriate.
A 2016 federal law established the Task Force on Research Specific to Pregnant Women and Lactating Women to identify research gaps and provide future guidance.
The task force’s final report recommended removing the classification of pregnant women as a “vulnerable population” in research, developing treatments specifically for them, and expanding the workforce of specialists in obstetric and lactation therapies.
While progress has been made, Srinivas stressed the need for further education of healthcare providers and patients on the role of maternal-fetal specialists in decision-making before pregnancy.
“I’ve had many conversations with patients unsure about their options,” she said. “These are the individuals we aim to support, helping them make informed decisions for their health and their future.”
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