FDA Considers Warning Labels on Antidepressants for Pregnant Patients

The Food and Drug Administration (FDA) is contemplating the addition of warning labels to antidepressants prescribed to pregnant individuals, despite a prevailing medical consensus that these medications are safe. On July 21, 2023, the FDA convened an advisory panel that comprised specialists from various fields, including six university professors, a psychiatrist, and the chief of maternal-fetal medicine at MetroWest Medical Center in Massachusetts.

During the meeting, the panel expressed concerns regarding the potential risks associated with the use of selective serotonin reuptake inhibitors (SSRIs), a commonly prescribed class of antidepressants that includes medications like Zoloft, Lexapro, and Prozac. The panel’s discussions centered on the belief that serotonin may play a vital role in fetal organ development, prompting them to explore alternative depression treatments such as “healthy relationships” and “natural light exposure.”

Dr. Marty Makary, the FDA Commissioner, stated, “From a national standpoint, the more antidepressants we prescribe, the more depression there is,” although he did not provide supporting evidence for this assertion. He highlighted a unique challenge during pregnancy: many individuals may not realize they are pregnant in the first trimester, complicating the process of discontinuing SSRIs, which often require gradual tapering.

Despite the panel’s concerns, research from Johns Hopkins University indicates that antidepressants are not associated with birth defects. Nevertheless, approximately 30% of infants born to mothers taking these medications may experience neonatal adaptation syndrome, which can result in symptoms such as jitteriness and irritability.

Reactions to the advisory panel’s proposal have been sharply divided. Critics, including medical experts in maternal health, argue that the proposed warning labels fail to consider the significant risks associated with untreated depression during pregnancy. “The FDA panel on SSRIs and pregnancy was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders,” stated Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists. He pointed out that only one of the ten panelists acknowledged the critical role of SSRIs in preventing the severe consequences of untreated anxiety and depression during pregnancy.

Mental health issues are currently cited as the leading cause of pregnancy-related deaths, according to the Centers for Disease Control and Prevention. Dr. Fleischman further argued that the claims made by the panelists could incite fear among patients, potentially leading them to avoid necessary treatment.

The Massachusetts General Hospital Center for Women’s Mental Health echoed these concerns, emphasizing the panel’s lack of clinical representation. “Only one of the ten panelists was a clinician who treats women with psychiatric disorders during pregnancy,” the center stated on its website. They cautioned that the FDA’s presentation of such an unbalanced perspective could place patients at risk, reinforcing the importance of informed and evidence-based discussions surrounding the treatment of depression in pregnant individuals.

As the FDA evaluates the potential implications of the advisory panel’s recommendations, the ongoing debate highlights the need for a careful balance between addressing risks and ensuring that those with mental health conditions receive appropriate care during pregnancy.