By Maryanne Demasi at Brownstone dot org.

Across the world, thousands of pregnant women are being prescribed antidepressants. Yet few are warned about the potential harms to their unborn babies.

That concern came to the forefront at a 2-hour expert panel convened last month by the US Food and Drug Administration (FDA), moderated by Dr Tracy Beth Høeg, the agency's senior adviser for clinical sciences.

A lineup of doctors, scientists, and former regulators gathered to examine a thorny question: do selective serotonin reuptake inhibitors (SSRIs) cause more harm than good when used during pregnancy?

Their opinions were not unanimous, but all agreed on one striking fact - there are no "gold-standard" randomised trials that have addressed the issue.

Instead of sparking serious debate, the panel was savaged by the media. The ferocity of the reaction only highlighted how difficult it has become to speak honestly when the message challenges psychiatric drugs.

A Long Overdue Discussion

FDA Commissioner Dr Marty Makary opened the session with a stark warning. "We're losing the broader battle of addressing mental health in the United States," he said. "The more antidepressants we prescribe, the more depression there is."

He cautioned that serotonin plays a crucial role in foetal development and warned that SSRIs have been "implicated in postpartum haemorrhage, pulmonary hypertension, cognitive downstream effects in the baby, as well as cardiac birth defects."

Dr Anick Bérard, an epidemiologist at the University of Montreal, said "depression and anxiety in pregnancy is extremely prevalent" and warned the problem surged during Covid-19.

"Since the pandemic started, the prevalence of depression and anxiety in pregnancy more than doubled. It was close to 25 to 30% at the peak of the pandemic," she said.

"Six percent of pregnant women will take an SSRI at one point in time in their pregnancy," she added.

Bérard cautioned that "using SSRIs is not the miracle solution in the sense that 12% of women that are using SSRIs remain depressed in pregnancy."

Birth Defects

Maternal-foetal medicine specialist Dr Adam Urato was unequivocal. "Never before in human history have we chemically altered developing babies like this…and this is happening without any real public warning," he said.

Urato told the panel that patients are routinely misled.

"The only counselling they received is that SSRIs don't affect the baby or cause complications. This is simply not accurate or adequate," he said, adding that FDA labels fail to warn about harms such as preterm birth, pre-eclampsia, or the fact that SSRIs alter foetal brain development.

Published research has raised similar concerns.

A BMJ study found birth defects occurred 2 to 3.5 times more frequently in babies exposed to paroxetine or fluoxetine early in pregnancy. A JAMA Psychiatry study found venlafaxine was associated with the highest number of defects. And a 2018 meta-analysis covering more than nine million births found a modestly increased risk (11%) of congenital malformations linked to early SSRI use.

"SSRIs cross the placenta and enter the foetal brain," Urato explained. "These drugs alter the mom's brain. Why wouldn't they affect the babies?"

He pointed to ultrasound studies showing SSRI-exposed foetuses with "different movement and behaviour patterns," and noted that newborns can present with "jitteriness, breathing difficulties, and higher rates of admission to the neonatal intensive care unit."

By his count, "a dozen consecutive MRI studies" now demonstrate that prenatal SSRI exposure alters the developing brain.

Tapering Hardly Discussed with Pregnant Women

Dr Josef Witt-Doerring, a psychiatrist and former FDA official, said women often come to him unaware of the risks. "They've never heard of these things," he said. "And they feel incredibly betrayed."

He helps patients taper off psychiatric drugs, but warned, "There's a black hole of knowledge on how to taper these medications."

He suggest...