FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say
The panel had promised to feature diverse viewpoints about antidepressants and pregnancy. But nearly all of the 10 panelists bucked medical consensus on the drugs' safety and emphasized what they said were risks of taking the drugs while pregnant — such as causing autism, miscarriages or birth defects. In some cases, they claimed that antidepressants don't work at all and that depression goes away on its own.
Three of the 10 panelists were from outside the United States. Another runs a clinic to help people taper off of psychiatric drugs.
'They were really rousing concerns about safety that are not evidence-based or established and not at all balanced with concerns about the risks of untreated depression,' said Dr. Joseph Goldberg, a clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City.
Dr. Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia, said, 'I'm disappointed that the FDA brought people in from outside of the United States when there's so many experts here in the United States who truly know this [medical] literature inside and out.'
A spokesperson for the FDA said in a statement that the claim that the panel was one-sided was 'insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels.' The spokesperson added that FDA Commissioner Martin Makary 'has an interest in ensuring policies reflect the latest gold standard science and protect public health.'
Health and Human Services Secretary Robert F. Kennedy Jr. has called for a probe into the risks of antidepressants. His 'Make America Healthy Again' report in May claimed there were 'potentially major long-term repercussions' associated with use of the drugs in childhood.
The panel discussion focused on a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, which includes Lexapro, Prozac and Zoloft. The medications increase levels of serotonin, a chemical messenger in the brain that can improve mood.
Psychiatrists often advise women who are taking SSRIs to continue doing so during pregnancy, since the risks of untreated depression tend to outweigh the potential risks of the medication to mother and child. However, the decision is a personal one.
For ethical reasons, there are no randomized-control trials of SSRIs in pregnant women, meaning data on potential risks mostly comes from observational studies and drug registries.
Some babies born to mothers taking SSRIs may develop symptoms such as jitteriness, irritability or difficulty eating or sleeping that resolve quickly — what's known as 'neonatal adaptation syndrome.' The symptoms may be caused by medication in the babies' systems or withdrawal from it.
Certain studies have also found a slightly elevated risk of miscarriage associated with antidepressant use in pregnancy, though others have found no association. However, there's no convincing evidence to suggest that SSRIs are linked to autism or birth defects.
'Well-controlled studies continue to not find an association,' Payne said.
Women with histories of depression are also at an increased risk of symptoms' recurring during pregnancy, and depression can come with its own risks — including thoughts of self-harm or low birth weight.
'The best thing a pregnant individual could do for herself and her baby is to get the treatment that they need,' said Dr. Nancy Byatt, a perinatal psychiatrist at UMass Chan Medical School, who wasn't part of the panel.
In addition to raising concerns about side effects, several panelists questioned the efficacy of antidepressants or suggested that data favoring the use of SSRIs was manipulated by the pharmaceutical industry.
'It's been said that SSRIs help people who are severely depressed. They don't,' said David Healy, an FDA panelist and fellow at the Royal College of Psychiatrists in the United Kingdom.
Goldberg and other psychiatrists said that's simply untrue.
'You can say the moon landing was faked. Conspiracy theories abound in our world. But there is not a doubt about whether SSRIs work,' said Goldberg, a past president of the American Society of Clinical Psychopharmacology who has previously consulted for pharmaceutical companies. He said he was invited to join the FDA panel but declined because the language of the invitation suggested it wouldn't be a fair discussion.
Healy, the panelist, also claimed that some people 'recover spontaneously' from depression.
Another panelist, psychologist Roger McFillin — who hosts a podcast that challenges conventional mental health advice — suggested that depression wasn't an illness but rather a product of 'women just naturally experiencing their emotions more intensely.' He added, without evidence, that many women feel coerced into taking antidepressants.
Psychiatrists who weren't part of the discussion broadly decried those characterizations.
'I have never, ever, ever, ever heard of a third party pushing a prescription in pregnancy,' Goldberg said. However, he said he is aware of some obstetrician-gynecologists who aren't as familiar with SSRIs who have wrongly told pregnant patients to stop taking the medications.
The American College of Obstetricians and Gynecologists said in a statement Monday that SSRIs can be lifesaving for some pregnant people.
'Today's FDA panel on SSRIs and pregnancy was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy,' it said. 'On a panel of 10 experts, only one spoke to the importance of SSRIs in pregnancy as a critical tool, among others, in preventing the potentially devastating effects of anxiety and depression when left untreated during pregnancy.'
One panelist, Dr. Kay Roussos-Ross, a psychiatrist and an OB-GYN at the University of Florida College of Medicine, was the most vocal advocate for using SSRIs, often pushing back against others' assessments of the risks. Psychiatrists who weren't on the panel praised her science-backed commentary.
'All of us can find a study that agrees with exactly what we think,' Roussos-Ross told the panel. 'But we need to look at the data very objectively.'
Several psychiatrists who weren't on the panel said they worry that the discussion could lead to regulatory action that makes it harder to access SSRIs. For example, one panelist, Dr. Adam Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Massachusetts, called for stronger warnings on SSRI labels.
'I am just very nervous that some of the discourse around the risks of antidepressants could lead to even more barriers for people seeking care,' said Dr. Lindsay Lebin, an assistant professor of psychiatry at the University of Colorado Anschutz Medical Campus, who wasn't part of the FDA discussion.
This article was originally published on NBCNews.com
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