The U.S. Food and Drug Administration is focusing on selective serotonin reuptake inhibitors, a class of antidepressants that have long been criticized by Health and Welfare Director Robert F. Kennedy Jr.
On Monday morning, the FDA held a panel of 10 experts on the pregnancy use of SSRIs, including drugs such as fluoxetine (Prozac), sertraline (Zoloft), and citalopram (Celexa).
Nine of the 10 members of the panel were researchers, physicians, or psychologists who previously publicly questioned the safety of SSRIs or who generally opposed the use of antidepressants.
During the discussion, several panel members cited studies that lacked appropriate control, said doctors not involved in the panel. In other words, there was no way to be certain based on the study whether the observed health problems were caused by SSRI, underlying mood disorders, or other factors.
Other participants described the study findings inaccurately or incompletely, external experts said. For example, few panelists consider the risk of SSRI use compared to risks associated with untreated depression. In the United States, suicide is the main cause of mother death in the first year of a baby’s life.
An FDA spokesperson said the panel was part of a “broader efforts to modernize regulatory oversight by applying stricter, evidence-based standards on ingredient safety,” and did not respond to further questions about the agency’s potential next steps.
However, health professionals have expressed concern that the panel could ultimately prevent women from receiving the care they need.
“I was surprised and disappointed by the amount of misinformation presented,” said Dr. Katie Unverferth, germ psychiatrist and medical director of UCLA’s Maternal Mental Health Program.
“If you look at the body of the data, you can see that there is no consistent relationship. [of] She named some of the drug-induced harm panelists, where SSRIs with heart defects, pulmonary hypertension, or neurodevelopmental problems, and said, “This misinformation produces intrusive thoughts. It’s useless.”
The panel included only one maternal mood disorder specialist. Dr. Kay Ruthos Ross, obstetrician and gynecologist at the University of Florida School of Medicine and director of the Perinatal Mood Disorders Program – SSRI claimed it is a safe treatment option for serious mental health disorders during pregnancy.
“Mental health disorders are no different from medical disorders,” said Roussos-Ross.
“I want to emphasize that treatment for mental illness during pregnancy is not a luxury. That’s necessary,” she said. “We’re not asking [pregnant] Women take high tensives to risk death or death. We are not asking women to stop diabetic medication. SSRI should not be withheld as a possible treatment for women who need it. ”
The FDA did not answer questions about how panel experts were selected. Participant Dr. Josef Witt-Doerring runs a private clinic that helps patients pull away psychiatric medications. Another panelist, Dr. Roger McFillin, is a prolific podcaster, sceptic of germ theory, and the belief that it has been widely held as a fundamental truth in medicine since the 19th century is that infectious diseases are caused by microorganisms.
The panelist, a Welsh-born psychiatrist, issued many confounding and misleading statements, claiming that “mothers taking SSRIs while pregnant are at ten times the risk of giving birth to a baby with fetal alcohol syndrome” (the diagram illustrates the population of the 2011 study, not the public). Healy also said, “Drugs that cause birth defects can also cause autism spectrum disorder.”
Dr. David Ullat, chief of maternal and fetal medicine at Metrowest Medical Center in Framingham, Massachusetts, was the only panelist other than Ruthosros, who cared directly for pregnant patients. He spoke vigorously about potential disorders and the harmful nature of drugs to babies born.
“We’ve never chemically changed a baby like this,” he said in the discussion. “There is currently ample evidence to support a strong warning from the FDA about how drugs disrupt fetal development and affect moms.”
Roussos-Ross argued that the increased risk of birth defects in babies exposed to SSRIs during pregnancy is statistically insignificant, and that children of untreated depressed mothers are more likely to have later behavioral problems than mothers who took medication due to illness.
“I have that [medication] Women who need it aren’t necessarily harmful,” she said.
Now, panel moderator Tracy Beth Høeg, a sports medicine physician who is currently a senior advisor to clinical science at the FDA, said, “I’m going to do something unconventional. Sorry to play my favorites, but Dr. Urat, I want to weigh you.”
In response, Urath questioned the idea that depression could be alleviated with antidepressants.
“This idea about depression – [that it] Handle it as it can cause harm [it] You can see that receiving these chemicals and treatments has improved results. This is what we all want. It’s a hopeful idea,” he said. “But that’s not what the data actually shows.”
It was not clear which data he was referring to. In 2019, the most recent year when data is available, one in eight US adults had a prescription for antidepressants. Although drugs do not work for all people with major depression, analysis of multiple studies consistently finds that they are significantly better than placebo in alleviating symptoms of illness.
The drug, along with vaccines and food dyes, is a target for Kennedy’s Make America Healthy Movement. In his confirmation hearing and podcast appearances, Kennedy argues that drugs are linked to school shootings and are more difficult to quit than heroin. There is no evidence of either claim.
In February, President Trump placed Kennedy at the helm of the Make America Healthy Again Commission. This assessed, among other things, the “prevalence and threat of threat posed by prescribing selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants, and weight loss drugs.”
Healthcare professionals expressed dissatisfaction with the FDA’s approach.
“There is already a lot of shame and stigma surrounding these illnesses. There is a lot of shame and stigma to take medication during pregnancy or postpartum,” said Page Berenbaum, a perinatal mental health therapist and adjunct professor of social work at Hunter College. “We are taking a huge step in so many ways. [and] Eventually your life will be lost. ”
Alexandre Bonnin, an associate professor of pathology at USC, has been studying the effects of prenatal SSRI exposure on the developing fetal brain for many years.
The most recent, large-scale study in the field has found no statistically significant association between SSRI and fetal harm, he said. “Our findings at least at the basic science level suggest that using SSRI during pregnancy is beneficial if the mother is suffering from significant stress, anxiety, or depression, as mothers’ stress itself actually has many negative effects on fetal brain development,” he said.
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