The Food and Drug Administration (FDA) is considering placing a black-box warning on antidepressant use in pregnancy, alarming some doctors who worry that a reignited debate about the drugs’ safety will discourage pregnant people from seeking treatment.
FDA Commissioner Marty Makary recently hosted a panel discussion about the use of antidepressants during pregnancy, specifically serotonin reuptake inhibitors (SSRIs), with participants challenging the scientific consensus.
While the drugs may pose some risk during pregnancy, the risks associated with not treating mood disorders like depression, to both pregnant people and developing fetuses, are much higher, according to physicians and medical experts.
The American College of Obstetricians and Gynecologists (ACOG) released a statement calling the discussion “alarmingly unbalanced,” warning that it is dangerous to minimize the effects of mental health conditions during pregnancy and postpartum.
“Unfortunately, the many outlandish and unfounded claims made by the panelists regarding SSRIs will only serve to incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need,” the statement reads.
Many panelists suggested pregnant people should be better warned about the harms the drugs pose to a developing fetus and discussed changing current labeling on antidepressants.
Makary said in his opening remarks the drugs could influence the development of organs like the brain and heart in utero. He added that SSRIs have been “implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertensions and cognitive downstream effects in the baby.”
One of the panelists, Anick Bérard, a professor of epidemiology at the University of Montreal, claimed that the use of the SSRIs paroxetine and fluoxetine greatly increased the risk of adverse health events like miscarriage or low birth weight.
For example, Bérard stated that SSRI use during pregnancy increased the absolute risk of miscarriage from about 6 percent to 10 percent.
“This needs to be well talked about when treating pregnant women who are depressed, anxious or using antidepressants,” she said.
Physicians and physician groups have since criticized the discussion, calling it “one-sided” given that only one of the 10 panelists spoke positively about SSRIs and how they can be used as an effective tool to treat depression and anxiety during pregnancy.
Tiffany Moore Simas, an OB-GYN at UMass Memorial Health, said the unbalanced nature of the discussion will worsen stigma around antidepressant use during pregnancy and that a “black box” label is not necessary on the drugs.
“Many perinatal individuals choose not to do pharmacotherapy for fear of fetal harm and for the stigma associated with psychiatric medication,” she said. “That panel added to this fear of harm.”
A spokesperson for the Department of Health and Human Services, which oversees the FDA, would not comment on any future policy decisions regarding antidepressants.
The spokesperson did say that suggesting the expert panel was “one-sided” or politically driven is “insulting” to its participants.
“Commissioner Makary has an interest in ensuring policies reflect the latest gold standard science and protect public health,” the spokesperson said. “To suggest that his engagement on women’s health signals a desire to manipulate outcomes is politically motivated and undermines the serious work being done to improve care for millions of women.”
Many people struggle with their mental health during pregnancy, with research showing that up to 20 percent of women experience depression during a pregnancy, and about 20 percent suffer from anxiety.
About 8 percent of these women take an SSRI to treat the conditions.
Those conditions carry health risks if left untreated, like preeclampsia, preterm birth, low birth weight, and suicide — one of the leading causes of maternal mortality in the United States.
Some research suggests that 5 to 14 percent of pregnant or postpartum people experience suicidal ideation and that suicide could account for 20 percent of postpartum deaths.
“There is a real, biologic reason why pregnant and postpartum persons are susceptible to these conditions, and we need to treat them as needed,” said Moore Simas. “There are consequences to not doing that.”
Recommending that a patient start or stay on an SSRI during pregnancy is not a decision that physicians take lightly, doctors told The Hill, and providers typically will try to limit the number of potentially harmful exposures to a fetus.
As a result, the first line of treatment for mild depression and sometimes moderate depression is therapy.
But moderate and severe depression are important to treat, and there is “reassuring” evidence that treating those conditions with SSRIs does not expose pregnant people to increased risks of birth defects, according to Nicole Leistikow, a psychiatry professor at the University of Maryland who specializes in treating women.
There is a roughly 3 to 5 percent chance of birth defects occurring in any given pregnancy, according to data from the Centers for Disease Control and Prevention, and numerous large studies conducted over the last 30 years show that SSRIs do not increase this risk.
FDA panelists noted that there have not been randomized trials to assess the safety of SSRIs, which some physician groups, like ACOG, agree should be conducted and prioritized.
But physicians who spoke with The Hill noted that the studies panelists referenced were not well designed, with some having inappropriate control groups.
They added that well-designed studies on antidepressant use in pregnancy will compare outcomes between appropriate groups, like women with depression taking antidepressants and women with depression not taking antidepressants.
