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According to several psychiatrists who coordinated for the meeting, a Food and Drug Administration panel that discussed the use of antidepressants during pregnancy corresponded primarily to misinformation or facts about the use of antidepressants during pregnancy.
The panel was committed to characterising diverse perspectives on antidepressants and pregnancy. However, almost all of the 10 panelists have defied medical consensus on drug safety, highlighting what they said they had a risk of taking the drug while pregnant, including causing autism, miscarriage and birth defects. In some cases, antidepressants did not work at all, claiming that depression would disappear on its own.
Three of the 10 panelists came from outside the United States, and another panelist runs a clinic to help people defeat psychiatric drugs.
“They’re also a part of the world,” said Dr. Joseph Goldberg, clinical professor at the ICAHN School of Medicine, New York City.
“I’m disappointed that the FDA brought people from outside the US when there are so many experts in the US who really know this, and I’m disappointed that the FDA has brought people from outside the US when they have so many experts in the US that really know this. [medical] Internal and external literature,” added Dr. Jennifer Payne, director of the University of Virginia’s Reproductive Psychiatry Research Program.
An FDA spokesman said the claim that the panels are unilateral was “shamed by independent scientists, clinicians and researchers who devote their expertise to these panels.” The spokesman added:[FDA] Commissioner McCulley is interested in ensuring that it reflects the latest gold standard science and protects public health. ”
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Health and Human Services Secretary Robert F. Kennedy Jr. is calling for an investigation into the risks of antidepressants. His “Make America Healthy” report in May claimed there were “potentially major long-term effects” associated with childhood drug use.
The panel discussion focused on the class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, including Lexapro, Prozac, and Zoloft. The medicine increases the levels of serotonin, a chemical messenger in the brain that can improve your mood.
Psychiatrists often advise women taking SSRIs during pregnancy, as the risk of untreated depression tends to outweigh the potential risks of medication to mothers and children. However, the decision is personal.
For ethical reasons, there are no randomized controlled trials of SSRIs in pregnant women. This means that data on potential risks comes primarily from observational studies and drug registry.
Some babies born to mothers taking SSRIs can develop symptoms such as jitteriness, irritability, or sleep disorders that quickly resolve what is known as “neonatal indication syndrome.” Symptoms can be caused by medications in the baby’s system and withdrawal from it.
Specific studies also found a slightly increased risk of miscarriage associated with antidepressant use during pregnancy, but none of the other studies have been linked. However, there is no compelling evidence to suggest that SSRIs are associated with autism or birth defects.
“Well controlled studies don’t continue to find any relevance,” Payne said.
Women with a history of depression are also at a higher risk of repeated symptoms during pregnancy, and depression may have unique risks, including thoughts of self-bearing strength and birth weight.
“The best thing a pregnant individual can do for themselves and their baby is getting the treatment they need,” said Dr. Nancy Byatt, a perinatal psychiatrist at UMass Chan School of Medicine, who was not part of the panel.
In addition to raising concerns about side effects, several panelists have questioned the effectiveness of antidepressants or suggested that data supporting the use of SSRIs will be manipulated by the pharmaceutical industry.
“SSRIS is said to help people who are seriously depressed. They are not,” said David Healy, a Royal Psychiatrist and Fellow, FDA panelist and fellow in the UK.
Goldberg and other psychiatrists said that it simply wasn’t true.
“You can say that the lunar landing was fake. There are a lot of conspiracy theories in our world, but there is no doubt as to whether SSRIs are at work,” said Goldberg, former chairman of American clinical psychopharmacology, who consulted the drug company. He said he was invited to join the FDA panel but declined because he suggested that the language of the invitation was not a fair discussion.
Panelist Healy insisted that some people “recover naturally” from depression.
Another panelist, psychologist Roger McFillin, hosts a podcast that challenges traditional mental health advice – suggesting that depression is not a disease, but the product of “women naturally experience emotions more vigorously.” He added without evidence that many women feel forced to take antidepressants.
Psychiatrists, who were not part of the discussion, widely condemned their characterization.
“I’ve never heard of a third party pushing a prescription while pregnant,” Goldberg said. However, he said he knows obstetricians who are not familiar with SSRIs accidentally telling pregnant patients to stop taking medication.
The U.S. University of Obstetrics and Gynecology said in a statement Monday that SSRIs could save lives for some pregnant individuals.
“Today’s FDA panel on SSRIS and pregnancy is surprisingly unbalanced and did not properly recognize the harm of untreated perinatal mood disorders during pregnancy,” the organization said. “Only one panel of 10 experts spoke about the importance of SSRIs during pregnancy as a particularly important tool to prevent the potentially devastating effects of anxiety and depression if left untreated during pregnancy.”
One panelist, Dr. Kay Roussos-Ross, a psychiatrist and ob-gyn at the University of Florida School of Medicine, was the most vocal advocate for the use of SSRIs, often opposed the assessment of the risks of others. The psychiatrist, who was not on the panel, praised her scientifically supported commentary.
“We can all find research that agrees with what we think,” Ruthos Ross told the panel. “But we need to look at the data very objectively.”
Several psychiatrists who were not on the panel said they were worried that the discussion could lead to regulatory actions that would make access to SSRIs more difficult. For example, Dr. Adam Urat, the chief of maternal fetal medicine at Metrowest Medical Center in Framingham, Massachusetts, asked for stronger warnings about the SSRI label.
“We are extremely nervous that some of the discourses on the risk of antidepressants could lead to more barriers to those seeking care,” said Dr. Lindsay Levin, assistant professor of psychiatry at the FDA’s Anschutz University medical campus.
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