Introduction to the FDA Panel Discussion
A Food and Drug Administration panel on Monday discussing the use of antidepressants during pregnancy largely amounted to misinformation or facts taken out of context, according to several psychiatrists who tuned into the meeting.
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 do not work at all and depression goes away on its own.
Panel Composition and Bias
Three of the 10 panelists were from outside the U.S. 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.
“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,” added Dr. Jennifer Payne, director of the Reproductive Psychiatry Research Program at the University of Virginia.
Response from the FDA
A spokesperson for the FDA said 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 Makary has an interest in ensuring policies reflect the latest gold standard science and protect public health.”
Antidepressants and Pregnancy: The Medical Consensus
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.
Risks and Benefits of SSRIs During Pregnancy
For ethical reasons, there are no randomized-control trials of SSRIs in pregnant women, meaning that 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 baby’s system 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.
The Importance of Treating Depression During Pregnancy
Women with a history 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 was not part of the panel.
Concerns Over Misinformation and Regulatory Action
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 would not be a fair discussion.
Conclusion
The FDA panel discussion on the use of antidepressants during pregnancy has sparked controversy among psychiatrists, with many expressing concerns over the spread of misinformation and the potential for regulatory action that could limit access to these medications. It is essential to rely on evidence-based information and to consider the risks and benefits of SSRIs during pregnancy to ensure the best possible outcomes for both mothers and babies.
FAQs
Q: Are SSRIs safe to use during pregnancy?
A: While there are potential risks associated with SSRIs, the medical consensus is that the benefits of these medications often outweigh the risks, especially for women with a history of depression.
Q: Can SSRIs cause birth defects or autism?
A: There is no convincing evidence to suggest that SSRIs are linked to autism or birth defects.
Q: What are the risks of untreated depression during pregnancy?
A: Untreated depression can come with its own risks, including thoughts of self-harm or low birth weight.
Q: Should women stop taking SSRIs during pregnancy?
A: The decision to stop or continue taking SSRIs during pregnancy should be made on an individual basis, taking into account the risks and benefits of the medication and the woman’s medical history.
