An FDA panel spread misinformation about SSRI use in pregnancy, alarming doctors

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Nearly one in five pregnant women and new moms in this country suffers from anxiety and depression. And 6-8% of pregnant women are prescribed a group of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs).

But a recent expert panel organized by the U.S. Food and Drug Administration cast doubt on the safety of SSRIs — even though these drugs are largely considered safe by healthcare providers.

Those comments have sparked a swath of criticism from a number of prominent medical societies.

“Untreated or undertreated depression during pregnancy carries health risks, such as suicide, preterm birth, preeclampsia, and low birth weight,” the Society for Maternal-Fetal Medicine wrote in a statement late last month. “Unfortunately, misinformation about depression and its treatment creates confusion and doubt among patients and the public leading to unnecessary barriers to care.”

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Opening the panel discussion on FDA on July 21, FDA Commissioner Marty Makary said that SSRIs have been “implicated” by studies to be involved in a range of health effects, including pulmonary hypertension and cardiac defects in babies. Then a majority of the panelists, including psychiatrists, psychologists and a social work professor, cited studies they said illustrate serious health risks, like miscarriage and autism.

Several groups of healthcare providers, including the American College of Obstetricians and Gynecologists (ACOG) and the National Curriculum for Reproductive Psychiatry have spoken out against many of the claims made by the panel, saying that it misrepresented evidence and spread misinformation.

“As experts in high-risk pregnancies, the Society for Maternal-Fetal Medicine (SMFM) and its members are alarmed by the unsubstantiated and inaccurate claims made by FDA panelists concerning maternal depression and the use of SSRI antidepressants during pregnancy,” according to the statement from SMFM.

“Robust evidence” illustrates the safety of SSRI use in pregnancy, according to the ACOG statement, which added that most of these medications “do not increase the risk of birth defects.”

Responding to that criticism, spokesperson for the Department of Health and Human Services, Andrew Nixon wrote this to NPR in an email: “The claim that the FDA’s expert advisory process is one-sided or politically driven is insulting to the independent scientists, clinicians, and researchers.”

Scientific ‘apples and oranges’

Some of the studies cited by the panelists as evidence of harm didn’t even involve pregnant and postpartum women, says Dr. Jennifer Payne, a reproductive psychiatrist at the University of Virginia and a past president of the Marcé of North America, an organization working to prevent and treat mental health conditions during and after pregnancy.

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For example, British psychiatrist Dr. Joanna Moncrieff referenced a study in youth linking SSRIs to increased suicidality in a “very small proportion of” those taking the medication, she said.

Many of the studies referenced by some panelists have been disproven, notes Payne, like the papers linking SSRI use in pregnancy to cardiac defects in infants. “That has been debunked over and over,” she says.

And several studies mentioned on the panel were “poorly controlled,” says Payne.

“So if you’re comparing a pregnant patient who was taking an SSRI, the control group should be the pregnant patient with mental health abnormalities who hasn’t taken an SSRI,” explains Dr. Christopher Zahn, chief of Clinical practice with the American College of Obstetricians and Gynecologists or ACOG, who wasn’t part of the panel. “And part of the problem with a number of those studies [cited by panelists] is they don’t use the right control group. It’s really apples and oranges.”

And studies that are well-controlled — in other words, those that compare pregnant women on SSRIs with pregnant women with mental health conditions not taking the drugs — do not find the risks highlighted by the FDA panel.

“The use of SSRIs in pregnancy is extremely well studied,” says Dr. Nancy Byatt, a perinatal psychiatrist at the UMass Chan School of Medicine. “We have data on hundreds and thousands of individuals exposed to SSRIs in pregnancy.”

That data show that by and large, SSRI’s are safe. “What the overall data shows is that antidepressants are not associated with major birth defects,” says Byatt. And neither are they associated with a significantly higher risk of miscarriage or postpartum hemorrhage, as suggested by some panelists.

The impacts of untreated perinatal depression

One issue that was not discussed enough by the panel, according to Byatt and other experts on perinatal mental health, is the well-documented health impacts of untreated mental health symptoms in pregnant and postpartum women. Only one panelist, Dr. Kay Roussos-Ross, OBGYN and perinatal psychiatrist at the University of Florida, spelled out those impacts.

“When mental health conditions go untreated, these women are less likely to attend their prenatal care appointments and they’re more likely to use substances during their pregnancy,” said Roussos-Ross. “They are also more likely to face additional risks, such as pre-eclampsia and cesarean delivery.” They’re also at a higher risk of suicide, she said. Mental health remains the leading cause of maternal deaths in the United States, including deaths from suicide.

“And there’s this huge literature on the effects of postpartum depression, on IQ, language development, behavioral problems” in children, says Payne. “It’s as clear as a bell that you want mom to be well, during pregnancy and postpartum.”

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However, SSRIs aren’t the only treatment option for pregnant and postpartum women, say Payne and others.

“We have a lot of tools in our toolbox,” says Byatt.

For mild depression or anxiety, the first line of treatment is psychotherapy, or talk therapy, she says. “We have evidence-based psychotherapies that we can, should and do use in pregnancy and postpartum.”

There’s also psychosocial treatments, like peer support, which can be very helpful in improving pregnant women’s and new moms’ symptoms.

Adding practices like exercise, yoga and meditation to those treatments is also something Byatt recommends to her patients.

“Often people can’t access therapy quickly because of lack of insurance or even if people do have insurance, it’s extraordinarily challenging for people to access evidence-based quality therapy,” notes Byatt.

So for those women, and ones with moderate to severe symptoms, she says, SSRIs are a helpful option.