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FDA Panel Questions SSRI Use in Pregnancy


— July 24, 2025

Experts debate risks and benefits of SSRI use during pregnancy for mothers.


A recent discussion by a group of professionals selected by the FDA raised new concerns about how antidepressants known as SSRIs are being used during pregnancy. While these medications help many people manage depression, SSRI use during pregnancy remains a topic of debate. Panelists at the meeting spoke about the possibility that SSRIs might affect a baby’s development in the womb. These possible effects have been reported in some studies but are still not fully understood.

The panel included doctors from different fields, including psychiatry, obstetrics, and psychology. Some of them have long questioned the benefits of SSRIs and have even compared them to placebos. Others said the risks to babies—including heart problems, lung complications, and behavior issues like attention disorders or anxiety—have not gotten enough attention. The challenge is that strong studies are limited, since pregnant women are usually not included in drug trials. Most of the current data comes from observational studies, which can show patterns but don’t always prove cause and effect.

One doctor pointed out that the brain and body of a baby develop in ways that may be affected by serotonin, the brain chemical targeted by these medications. Other experts pointed out the need to consider how serious untreated depression can be during pregnancy. Leaving depression untreated can lead to early birth, lower birth weight, or other complications. Some mothers who stop their medication while pregnant may have a much higher chance of seeing their depression return. This can raise the risk of overdose, suicide, or poor connection with the baby after birth.

FDA Panel Questions SSRI Use in Pregnancy
Photo by SHVETS production from Pexels

Another panelist shared that nearly a third of babies exposed to SSRI use late in pregnancy may go through a condition that causes them to be shaky or fussy after birth. While the symptoms often clear up in a short time, the experience can be distressing for both the baby and the parents. Still, other studies have shown changes in brain activity in babies whose mothers took these medications while pregnant, though the long-term impact is unclear.

Some on the panel asked the FDA to change the warning labels on these medications. They believe current information on drug packaging is not strong enough to help people understand the risks. One doctor even suggested adding QR codes on bottles that could lead patients to short videos explaining what they need to know in plain language.

There was also disagreement among panelists about who should be giving this information. Some said it’s the job of the FDA to warn the public in more obvious ways. Others said the responsibility should fall on doctors, who can tailor the message to each patient’s situation.

Alternative treatments like therapy or older antidepressants were brought up as other possible choices. A few speakers suggested that women may not need medications at all. One psychiatrist questioned whether antidepressants truly help most people and said the differences between drug and placebo are often small.

However, not everyone agreed with this more skeptical view. One former FDA official warned that comments downplaying the value of SSRI use could cause panic. He said such claims might scare people away from getting help for a serious mental health problem. He also noted that many SSRIs have been well studied and found to be safe during pregnancy.

The meeting ended without any formal rule changes, but it stirred debate about how depression in pregnancy should be handled. The biggest concern from many was making sure that pregnant women understand both the possible risks of medication and the real dangers of untreated depression. The topic remains complicated, with strong views on both sides and many unanswered questions about how best to support mothers and their babies.

Sources:

FDA Panel Takes Aim at SSRI Use During Pregnancy

FDA panel promotes misinformation about antidepressants during pregnancy, psychiatrists say

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