The U.S. Food and Drug Administration is turning its attention to selective serotonin reuptake inhibitors, a class of antidepressant drugs long criticized by Health and Human Services Secretary Robert F. Kennedy Jr.
On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications like fluoxetine (Prozac), sertraline (Zoloft) and citalopram (Celexa), among others.
Nine of the panel’s 10 members were researchers, doctors or psychologists who have previously questioned the safety of SSRIs publicly or spoken out against antidepressant use in general.
Over the course of the discussion, several panel members cited studies that lacked appropriate controls, physicians not involved with the panel said. In other words, there was no way to be certain on the basis of the studies whether the observed health problems were caused by SSRIs, the underlying mood disorder or some other factor.
Other participants described study findings inaccurately or incompletely, said outside experts. For example, few panelists considered the risks of SSRI use relative to the risks associated with untreated depression, which also contributes to poor outcomes for children and mothers. In the U.S., suicide is a leading cause of maternal death in the first year of a baby’s life.
An FDA spokesperson said the panel was part of the agency’s “broader efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight” and did not respond to further queries about the agency’s potential next steps.
But healthcare professionals expressed concern that the panel could ultimately prevent women from getting the care they need.
“I was surprised and disappointed by the amount of misinformation that was presented,” said Dr. Katie Unverferth, a reproductive psychiatrist and medical director of UCLA’s Maternal Mental Health Program.
“When we look at the body of data … we find that there are no consistent associations [of] SSRIs with cardiac defects, pulmonary hypertension or neurodevelopmental issues in offspring,” she said, naming some of the harms panelists attributed to the drugs. “This misinformation just creates intrusive thoughts. It’s not helpful.”
The panel included just one specialist in maternal mood disorders — Dr. Kay Roussos-Ross, an obstetrician-gynecologist and director of the Perinatal Mood Disorders Program at the University of Florida College of Medicine — who argued that SSRIs are for most patients a safe treatment option for serious mental health disorders in pregnancy.
“Mental health disorders are no different than medical disorders,” said Roussos-Ross.
“I want to stress that treating mental illness in pregnancy is not a luxury. It’s a necessity,” she said. “We’re not asking [pregnant] women to not take their anti-hypertensives and risk death to them or their baby. We’re not asking women to stop their diabetes medications. We should not be withholding SSRIs as a possible treatment for women who need it.”
The FDA did not respond to questions about how experts were selected for the panel. Participant Dr. Josef Witt-Doerring runs a private clinic that helps patients wean off psychiatric medication. Another panelist, Dr. Roger McFillin, is a prolific podcaster and a skeptic of germ theory, the belief — widely held as a fundamental truth in medicine since the 19th century — that infectious diseases are caused by microorganisms.
Panelist Dr. David Healy, a psychiatrist from Wales, made a number of confounding and misleading statements, insisting that “mothers who are taking SSRIs in pregnancy have a 10-fold greater risk of having a baby with fetal alcohol syndrome” (that figure describes the subject population of a single 2011 study, not the general public). Healy also stated that “any drug that causes birth defects will cause autism spectrum disorder also,” a claim that has no basis in any scientific research.
Dr. David Urato, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Mass., was the only panelist besides Roussos-Ross who cares directly for pregnant patients. He spoke forcefully on the potential harms the drugs pose to developing babies.
“Never before in human history have we chemically altered babies like this,” he said during the discussion. “There is now more than enough evidence to support strong warnings from the FDA about how drugs disrupt fetal development and impact the moms.”
Roussos-Ross argued that the increased risk of birth defects for babies exposed to SSRIs in pregnancy was statistically insignificant, and that children of mothers with untreated depression were more likely to have later behavioral problems than those of mothers who took medication for the disease.
“Having that [medication] not be available to women who need it would really be detrimental,” she said.
At this, panel moderator Tracy Beth Høeg — a sports medicine doctor who is now a senior advisor for clinical sciences at the FDA — said, “I’m going to do something unconventional. I’m sorry to play favorites, but Dr. Urato, I want you to weigh in now.”
In response, Urato questioned the idea that depression can be alleviated with antidepressant medication at all.
“This idea about depression — [that it] can cause harm and therefore we treat [it] with these chemicals, and by getting the treatment we see improved outcomes — this is something we all would want. It’s wishful thinking,” he said. “But it’s not actually what the data shows.”
It was not clear to which data he was referring. In 2019, the most recent year for which data are available, one in every eight U.S. adults had a prescription for antidepressant medication. While the drugs don’t work for all people with major depression, analyses of multiple studies have consistently found them to be significantly better than placebos at alleviating illness symptoms.
The drugs have been a target of Kennedy’s Make America Healthy Again movement, along with vaccines and food dyes. In his confirmation hearings and on podcast appearances, Kennedy has claimed — inaccurately — that the drugs are both linked to school shootings and harder to quit than heroin. There is no evidence for either claim.
In February, President Trump placed Kennedy at the helm of the Make America Healthy Again Commission, a group tasked with, among other things, evaluating “the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.”
Healthcare professionals expressed frustration with the FDA’s approach.
“There is already so much shame and stigma that surrounds these illnesses. There is also a lot of shame and stigma around taking medication during pregnancy or the postpartum period,” said Paige Bellenbaum, a perinatal mental health therapist and adjunct professor of social work at Hunter College. “We are taking a giant step backwards in so many ways. This will reinstill the fear that was there to begin with [and] will ultimately result in the loss of life.”
Alexandre Bonnin, an associate professor of pathology at USC, has studied the effects of prenatal SSRI exposure on the developing fetal brain for years.
The most recent large studies in the field haven’t found a statistically significant association between SSRIs and fetal harm, he said. “Our finding, at least at the basic science level, suggests that the use of SSRIs in pregnancy can be beneficial if the mom is under major stress, anxiety or depression, because the maternal stress actually itself has many negative effects on fetal brain development,” he said.
