By Independent News Roundup
The U.S. Food and Drug Administration (FDA) needs to do a better job of warning pregnant women that taking SSRIs, a type of antidepressant, may harm them and their developing baby, doctors told the agency Monday.
The FDA hosted an expert panel of developmental biologists, psychiatrists, epidemiologists, obstetricians and mental health experts who discussed selective serotonin reuptake inhibitors (SSRIs) and pregnancy. The agency livestreamed the two-hour conversation on YouTube and X.
SSRIs have been “implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects,” said FDA Commissioner Marty Makary, who opened the event.
Nearly 1 in 4 middle-aged women and up to 5% of pregnant women are on an antidepressant, Makary said.
“Antidepressants like SSRIs can be an effective treatment for depression, but we have to stop and also look at the big picture,” he said. “The more antidepressants we prescribe, the more depression there is. … We have to start talking about root causes.”
SSRIs in particular warrant scrutiny as serotonin “may play a crucial role in the development of organs of a baby in utero,” he said.
Although opinions varied, most panelists agreed that women who are prescribed SSRIs rarely receive adequate informed consent about the risks to them or their future offspring.
“Many of the people that I talk to never received informed consent,” said Roger McFillin, a clinical psychologist and executive director of the Center for Integrated Behavioral Health. “And it is too late” if the information is given when a pregnant woman visits the doctor.
“By that time, you have exposed that developing baby to an SSRI,” McFillin added.
Michael Levin, Ph.D., professor of biology at Tufts University and director of the university’s Allen Discovery Center, shared results from studies he and colleagues conducted in which SSRIs disrupted the ability of chick and frog embryos to discern left from right, which negatively affected their organ development.
“SSRIs are very likely to cause certain kinds of defects,” Levin said. “Some may be fixed by the regenerative process of [an] embryo … some will not be able to repair.”
Another panelist cited research showing that children of women who were on an SSRI during pregnancy were more likely to experience depression when they reached adolescence.
FDA labels don’t mention risks identified by recent research
Tracy Beth Høeg, M.D., Ph.D., a senior adviser for clinical sciences at the FDA and moderator of Monday’s panel, said in a video about the event that the FDA’s existing warning label for “at least one SSRI” fails to mention risks identified in recent studies, including “higher rates of miscarriage, preterm birth and negative impacts on neurocognitive development in the child.”
SSRIs are a class of drugs that block brain cells’ reuptake of serotonin and are the most commonly prescribed antidepressants, according to the Mayo Clinic.
SSRIs cross the placental and blood-brain barrier and pass into breast milk, and may affect a fetus’s developing brain.
Dr. Adam Urato, chief of maternal and fetal medicine at the MetroWest Medical Center in Framingham, Mass., said he believes the FDA must strengthen the warnings.
“Never before in human history have we chemically altered developing babies like this, especially the developing fetal brain, and this is happening without any real public warning, and that must end,” Urato said.
Regulatory authorities need to get creative about how to inform women about the possible risks of SSRIs, said Dr. Josef Witt-Doerring, a psychiatrist who specializes in identifying and treating psychiatric adverse drug reactions and a former FDA medical officer.
Having a QR code “right on the bottle caps that says ‘watch me’” and links to “patient-friendly videos talking about the most important risks … could do wonders,” Witt-Doerring said.
Urato suggested a boxed warning, formerly called a black box warning, “so people realize the impact” that SSRIs can have on a woman’s pregnancy and developing fetus. An FDA letter to doctors could also help, he said.
In 2004, the FDA issued a black box warning for the use of antidepressants in young people, citing evidence that the drugs were linked to an increased risk of suicidal thinking, feeling and behavior in youth.
Dr. Kay Roussos-Ross, an expert in postpartum health at the University of Florida, pushed back, voicing concern about FDA action that might discourage or impede women’s access to SSRIs.
“Medications need to be in the toolbox, so we have these available for women who need them,” Roussos-Ross said. “Not every single woman will need an antidepressant, but for those that do, this is life-changing, and this is lifesaving.”
The FDA has yet to announce whether it will update existing SSRI labeling or issue new guidance. However, the agency indicated it would consider the panel’s input as it weighs possible actions.
Are SSRIs effective?
Some panelists criticized the narrative that SSRIs are effective at treating depression and shared evidence of their ineffectiveness.
Dr. Joanna Moncrieff showed the panel a slide depicting study results that found the difference in effects between those who received an antidepressant and a placebo was “absolutely minuscule.”
Moncrieff is a professor of critical and social psychiatry at University College London and author of “Chemically Imbalanced: The Making and Unmaking of the Serotonin Myth.”
NBC News, under the headline, “FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say,” quoted doctors who challenged the attack on SSRIs efficacy.
Dr. Joseph Goldberg, a clinical professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City and past president of the American Society of Clinical Psychopharmacology, told NBC, “You can say the moon landing was faked. Conspiracy theories abound in our world. But there is not a doubt about whether SSRIs work.”
Goldberg is a former consultant for the pharmaceutical industry. In 2018, he received over $140,000 from drug companies, according to data obtained by ProPublica.
Goldberg told NBC the FDA invited him to be on the panel, but he declined because he thought, based on the invitation’s language, that the event “wouldn’t be a fair discussion,” according to NBC.
SSRIs aren’t easy to stop taking
Panelists also cited research showing how difficult it is for some people to wean themselves off of SSRIs once they begin taking them.
“We did a study showing, among people who had taken antidepressants for two years, 80% could not come off antidepressants despite trying,” said Moncrieff.
The “Make America Healthy Again” report criticized the “overmedicalization” of U.S. youth with drugs, including SSRIs. The report cited research showing that some people who stop taking SSRIs experience withdrawal symptoms due to having become physically dependent.
A study published earlier this month in JAMA Psychiatry reported that patients who quit taking antidepressants, including SSRIs, did have symptoms a week after stopping the drug, but that the symptoms were “below the threshold for clinically significant” withdrawal.
However, critics such as James Davies, Ph.D., an associate professor of psychology at the University of Roehampton in England, said most of the trials reviewed by the JAMA study authors followed only those patients who had been on antidepressants for eight weeks.
Davies, whose research in 2019 found high rates of withdrawal symptoms with nearly half rated as “severe,” told The New York Times, “If you are looking at people on the drugs for eight weeks, you are not going to find withdrawal. It’s like saying cocaine isn’t addictive because we did a study on people who had only been taking it for eight weeks.”
Davies said the JAMA study, “if read uncritically,” could “cause
considerable harm by significantly downplaying the effects of real-world
antidepressant use.”
Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa.
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