Aria Bendix – NBC News
A panel of the Food and Medicines Administration (FDA) that debated Monday about the use of antidepressants during pregnancy was largely limited to spreading misinformation or data taken from context, according to several psychiatrists who tuned the meeting.
The panel had promised to present various views on antidepressants and pregnancy. However, almost all 10 panelists They challenged the medical consensus on drug safety And they emphasized what, according to them, were risks of taking them during pregnancy, such as causing autism, spontaneous abortions or birth defects. In some cases, they affirmed that antidepressants do not work at all and that depression disappears alone.
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Three of the 10 panelists were from outside the United States. Another directs a clinic to help people gradually reduce the consumption of psychiatric drugs.
“They were really generating concerns about security that are not based on evidence or established, and that are not compensated at all with concerns about the risks of depression without treatment,” said Dr. Joseph Goldberg, clinical professor of psychiatry at the Icahn School of Medicine of Mount Sinai in New York City.
Dr. Jennifer Payne, director of the Research Program in Reproductive Psychiatry at the University of Virginia, declared: “I am disappointed that the FDA has brought people outside the United States when there are so many experts here in the United States who really know this (medical) literature perfectly.”
An FDA spokesman declared that the statement that the panel was partialized was “an insult for independent scientists, doctors and researchers who dedicate their experience to these panels.” He added that the FDA Commissioner Martin Makary, “is interested in ensuring that policies reflect the most recent scientific standards and protect public health.”
The Secretary of Health and Human Services, Robert F. Kennedy Jr., has requested an investigation into the risks of antidepressants. His May report “Make America Healthy Again” said that the use of these drugs in childhood had “potentially important repercussions in the long term.”
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The round table focused on a class of antidepressants known as selective serotonin reuptake inhibitors (SSRs), which includes Lexapro, Prozac and Zoloft. These medications increase serotonin levels, a cerebral chemical messenger that can improve mood.
Psychiatrists often advise women who take SSRs who continue to take them during pregnancy, since the risks of unrelated depression They tend to overcome the potential risks of the medication for the mother and the baby. However, the decision is personal.
For ethical reasons, there are no randomized clinical trials of control over SSRs in pregnant women, which means that data on possible risks come mainly from observational studies and medication records.
Some babies born to mothers who take nSRS They can develop symptoms such as nervousness, irritability or difficulty in eating or sleeping They are quickly resolved, what is known as “neonatal adaptation syndrome”. The symptoms may be due to the medication present in the baby’s body or the abstinence of it.
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Some studies have also found a slightly higher risk of spontaneous abortion associated with the use of antidepressants during pregnancy, although others have not found any association. However, There is no convincing evidence to suggest that the SSRIs are related to autism or congenital defects.
“Well controlled studies still do not find an association,” said Payne.
Women with a history of depression also have a greater risk that symptoms reappear during pregnancy, and depression can lead to their own risks, such as self -harm or low weight thoughts at birth at birth.
“The best pregnant can do for itself and for your baby is to receive the treatment you need,” said Dr. Nancy Byatt, perinatal psychiatrist of the Chan Medicine Faculty of the University of Massachusetts (Umass), who was not part of the panel.
In addition to raising concerns about side effects, several panelists questioned the effectiveness of antidepressants or suggested that the data that favor the use of SSRIs were manipulated by the pharmaceutical industry.
“It has been said that the SSRIs help people with severe depression. It is not so,” said David Healy, a FDA panelist and a member of the Royal College of Psychiatrists of the United Kingdom.
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Goldberg and other psychiatrists They affirmed that this is simply false.
“It can be said that moon landing was a montage. The theories of conspiracy abound in our world. But there is no doubt that the SSRIs work,” said Goldberg, former president of the American Society of Clinical Psychopharmacology, who has previously been the consultant of pharmaceutical companies. He commented that he was invited to join the FDA panel, but declined because the language of the invitation suggested that it would not be a fair discussion.
Healy, the panelist, also said that some people “recover spontaneously” from depression.
Another panelist, the psychologist Roger McFillin – who presents a podcast that challenges the conventional mental health advice – suggested that depression is not a disease, but the product of “women experience their emotions with greater intensity naturally.” He added, without evidence, that many women feel obliged to take antidepressants.
Psychiatrists who did not participate in the debate widely criticized these descriptions.
“Never, never, never, I have never heard of a third party that press to prescribe medications during pregnancy,” Goldberg said. However, he claimed to be aware of some gynecologists-obstetras who are not so familiar with the SSRIs and who have erroneously recommend to pregnant patients who stop taking them.
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The American College of Obstetricians and Gynecologists declared on Monday that SSRIs can save the lives of some pregnant women.
“Today’s FDA panel about the SSRIs and pregnancy was alarmingly unbalanced and did not adequately recognize the damage of perinatal mood disorders not treated during pregnancy,” he said. “In a panel of 10 experts, only one talked about the importance of SSRs during pregnancy as a fundamental tool, among others, to prevent potentially devastating effects of anxiety and depression when they are not treated during pregnancy,” the organization said in a statement.
One of the panelists, Dr. Kay Roussos-Ross, psychiatrist and gynecologist-Obstetra of the Florida Faculty of Medicine, was the main defender of the use of the SSRIs, often contradicting the risk evaluations of others. The psychiatrists who were not part of the panel praised their comments with a scientific basis.
“We can all find a study that coincides exactly what we think,” Roussos-Ross said to the panel. “But we must analyze the data with great objectivity.”
Several psychiatrists who were not part of the panel They expressed concern that the debate could lead to regulatory measures that hinder access to ISRS. For example, a panelist, Dr. Adam Urato, Chief of Maternal-Fetal Medicine of the Metrowest Medical Center in Framingham, Massachusetts, requested more forceful warnings on the NSR labels.
“I am very concerned that part of the speech about the risks of antidepressants can generate even more barriers for people looking for medical attention,” said Dr. Lindsay Lebin, an attached professor of psychiatry at the Anschutz Medical Campus of the University of Colorado, who did not participate in the FDA debate.
