Doctors are sounding the alarm after a U.S. Food and Drug Administration expert panel recently questioned the safety of antidepressants for pregnant women. This panel’s findings are causing significant concern among medical professionals who say they misrepresent robust evidence.
Nearly one in five pregnant women and new mothers experience anxiety and depression. About 6-8% of pregnant individuals are prescribed SSRIs, a common class of antidepressants.
The panel, organized by the FDA on July 21, cast doubt on SSRI safety, despite widespread agreement among healthcare providers that these medications are largely safe. This has led to a strong backlash from major medical societies.
“Untreated or undertreated depression during pregnancy carries health risks, such as suicide, preterm birth, preeclampsia, and low birth weight,” stated the Society for Maternal-Fetal Medicine (SMFM) late last month. “Misinformation about depression and its treatment creates confusion and doubt among patients, leading to unnecessary barriers to care.”
FDA Commissioner Marty Makary opened the July 21 panel, stating that studies have “implicated” SSRIs in health effects such as pulmonary hypertension and cardiac defects in infants. Several panelists, including psychiatrists and psychologists, cited studies suggesting serious risks like miscarriage and autism linked to SSRIs.
However, major medical groups, including the American College of Obstetricians and Gynecologists (ACOG) and the National Curriculum for Reproductive Psychiatry, have criticized the panel’s claims. They argue the panel misrepresented evidence and spread misinformation.
The SMFM statement emphasized their alarm at the panel’s “unsubstantiated and inaccurate claims” regarding maternal depression and SSRI use. ACOG also stated that “robust evidence” supports SSRI safety in pregnancy, noting that most of these medications “do not increase the risk of birth defects.”
Andrew Nixon, a spokesperson for the Department of Health and Human Services, defended the FDA’s process, calling claims of it being one-sided “insulting to the independent scientists, clinicians, and researchers.”
Scientific ‘apples and oranges’
Dr. Jennifer Payne, a reproductive psychiatrist at the University of Virginia, noted that some studies cited by panelists involved youth, not pregnant or postpartum women. Dr. Joanna Moncrieff, a British psychiatrist, referenced a study on youth linking SSRIs to increased suicidality in a “very small proportion.”
Payne also stated that many cited studies were poorly controlled. Dr. Christopher Zahn, chief of Clinical Practice at ACOG, explained that proper studies compare pregnant women on SSRIs with pregnant women with mental health issues who are not taking the medication. He criticized studies that used incorrect control groups, calling them “apples and oranges.”
Well-controlled studies, which compare pregnant individuals on SSRIs with pregnant individuals with mental health conditions not taking the drugs, do not show the risks highlighted by the FDA panel. Dr. Nancy Byatt, a perinatal psychiatrist, stated that SSRI use in pregnancy is “extremely well studied,” with data from hundreds of thousands of individuals. This data indicates SSRIs are generally safe and not associated with major birth defects, miscarriage, or postpartum hemorrhage.
The impacts of untreated perinatal depression
Experts like Byatt and Dr. Kay Roussos-Ross, an OBGYN and perinatal psychiatrist, emphasized that the panel did not adequately discuss the significant health impacts of untreated perinatal depression. Untreated mental health conditions can lead to pregnant individuals missing prenatal appointments, increased substance use, pre-eclampsia, and cesarean deliveries. Mental health, including suicide, remains the leading cause of maternal deaths in the U.S.
Untreated postpartum depression can affect a child’s IQ, language development, and behavior. “It’s as clear as a bell that you want mom to be well, during pregnancy and postpartum,” Payne said.
Payne and others noted that SSRIs are not the only treatment options. Byatt stated, “We have a lot of tools in our toolbox.” For mild depression or anxiety, psychotherapy is the first line of treatment. Psychosocial treatments, like peer support, can also be very beneficial. Practices such as exercise, yoga, and meditation are also recommended.
However, accessing quality therapy can be challenging due to insurance issues. For women facing these barriers, or those with moderate to severe symptoms, SSRIs remain a helpful and evidence-based option.
