Taking Medication While Pregnant: Too Many Questions
“Should I take my medication while pregnant?” Many expecting women have to ask this question, because certain medications can harm fetuses in the womb. These potentially harmful drugs came to public attention after the thalidomide scare of the 1960s when they found that a newly developed drug for alleviating morning sickness actually caused significant birth defects in newborns. As a result, the U.S. Food and Drug Administration (FDA) adopted more secure regulations before drugs can be sold to the public. It also became widely accepted to exclude pregnant women from clinical trials to ensure the safety of both mother and child. A recent example is that pregnant women were not included in the initial COVID-19 vaccine trials.
However, according to a recent publication from the FDA, these policies have caused an enormous lack of data on the safety of drugs during pregnancy. In many situations, pregnant women and their doctors can only “weigh the benefits and risks” of taking certain medications without having access to credible or verifiable findings. As a result, pregnant women with medical conditions must make a tough choice: Either keep taking their medication, which could potentially harm their child, or stop taking their medication, thus leaving their medical condition untreated, which could harm both them and their child.
The most prevalent examples of this dilemma are psychotropic drugs, which treat mental disorders like anxiety, sleep, depression, and bipolar disorders. A comprehensive review published in 2019 suggests that women are at increased risk of suffering episodes of these disorders during pregnancy. For example, depression is the most common maternal disorder, and 25–30% of pregnant women get bipolar episodes, which correlates with low birth weight, preterm birth, and other complications. Therefore, pregnant women who already had these conditions before their pregnancy are at risk of worsening symptoms. However, despite this, with regards to the drugs that treat these disorders, few reliable studies have tested their safety in pregnant women.
However, according to a recent publication from the FDA, these policies have caused an enormous lack of data on the safety of drugs during pregnancy. In many situations, pregnant women and their doctors can only “weigh the benefits and risks” of taking certain medications without having access to credible or verifiable findings. As a result, pregnant women with medical conditions must make a tough choice: Either keep taking their medication, which could potentially harm their child, or stop taking their medication, thus leaving their medical condition untreated, which could harm both them and their child.
The most prevalent examples of this dilemma are psychotropic drugs, which treat mental disorders like anxiety, sleep, depression, and bipolar disorders. A comprehensive review published in 2019 suggests that women are at increased risk of suffering episodes of these disorders during pregnancy. For example, depression is the most common maternal disorder, and 25–30% of pregnant women get bipolar episodes, which correlates with low birth weight, preterm birth, and other complications. Therefore, pregnant women who already had these conditions before their pregnancy are at risk of worsening symptoms. However, despite this, with regards to the drugs that treat these disorders, few reliable studies have tested their safety in pregnant women.

Mental disorders are treated with a variety of medications: antidepressants for depression, benzodiazepines for anxiety, and mood stabilizers for bipolar disorder. Moreover, for many women, the onset of these mental disorders occurs around reproductive age, so the safety of these medications for pregnant women is of particular importance.
Image Source: Anna Shvets
The FDA has begun addressing this problem, pushing for more representative, safe, and credible data for pregnant women who need to take medications. In 2014, they required that all drug companies keep their labels up to date with any incoming research findings. Then, in 2018, they made a document reviewing the Scientific and Ethical Considerations for Inclusions in Clinical Trials, which provides ethical guidelines for future clinical trials that include pregnant women. Through this, they aimed to minimize any research risk, testing pregnant animals before pregnant women and ensuring that only clinical trials that can potentially benefit the woman’s health can proceed. These specifications can now help clinical trials move forward with including pregnant women in a safe, ethical, and clear manner.
These new FDA releases should stir a strong movement towards identifying safe medications for use during pregnancy while keeping women and babies safe from potentially harmful drugs. Similarly, the fact that many of these drugs in question are for mental illnesses brings awareness to the mental health struggles that many pregnant women face. Being able to make informed and confident decisions with their doctor about which drugs to take during their pregnancy is crucial and should be afforded to expecting mothers everywhere.
These new FDA releases should stir a strong movement towards identifying safe medications for use during pregnancy while keeping women and babies safe from potentially harmful drugs. Similarly, the fact that many of these drugs in question are for mental illnesses brings awareness to the mental health struggles that many pregnant women face. Being able to make informed and confident decisions with their doctor about which drugs to take during their pregnancy is crucial and should be afforded to expecting mothers everywhere.
Featured Image Source: Bokskapet
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