Late last month, the FDA advisory panel – on the heels of the president’s “make America healthy again” executive order scrutinizing psychotropic medications – raised debate around the safety of selective serotonin reuptake inhibitors (SSRIs) in pregnancy. Commonly called antidepressants, these medications are used to treat a range of disorders, and earlier this year a consortium of major mental health organizations pushed back on the administration’s stance.
As a perinatal psychiatrist who sees pregnant and postpartum people struggling with conditions such as depression and anxiety every week, I’m deeply concerned that this public discussion – chaired by the controversial FDA commissioner Marty Makary – shared significant misinformation about mental illness and the treatment modalities (with overly simplified statements denouncing “chemicals” during pregnancy).
Here in Washington DC, I recently examined a pregnant woman struggling with severe depression and anxiety. As she was nervously mulling treatment options we had discussed, she asked me questions about starting medication to treat her condition: will this affect my child’s development? How long will the medication stay in my child’s bloodstream? How much of the medication will go into my breast milk? Do I have to stay on it for ever?
These questions are part of everyday practice for those who care for individuals making decisions about treating their mental health challenges in the course of pregnancy. And answering them clearly is critical for people already dealing with some of the most difficult and vulnerable moments of their lives.
But giving established guidance becomes difficult at a time when the authorities themselves are platforming misinformation under the guise of scientific inquiry.
There isn’t enough space here to deconstruct all of the falsehoods shared by some of the FDA panelists, with often meandering anecdotes that did not address the core issue being discussed.
The panelists overstated risks, which may deter treatment, despite robust data supporting the safety of use of SSRIs when clinically indicated.
As the adage attributed to W Edwards Deming goes: “In God we trust; all others, bring data.” Here’s the data: we know that severe maternal mental health challenges occur during pregnancy and the postpartum period. And according to a recent national study, there have been large declines in mental health among pregnant women – one in five pregnant women struggles with conditions such as anxiety and depression during their pregnancy. Three in four pregnant persons are untreated. That’s more than 500,000 people every year who experience significant mental health issues before, during or after their pregnancies.
There are also real harms of untreated perinatal depression and anxiety – such as preterm birth, bonding difficulties, and even maternal death by suicide or overdose. The low, manageable neonatal risks generally support initiating and continuing SSRIs when they’re clinically needed. These women need and deserve evidence-based care.
And as for pregnant people who do take SSRIs, large reviews, called meta-analyses, find no overall rise in major birth defects from taking SSRIs during pregnancy, and occasional small links to heart problems with certain drugs disappear in larger studies. Some newborns exposed late in pregnancy may have an issue called neonatal adaptation syndrome – mild, brief withdrawal-like symptoms which include jitteriness, poor feeding and affect the baby’s breathing – but this almost always clears up quickly with routine care in the first week.
There is also an inherent problem in the way the FDA panelists spoke about the issue: one that minimized the health of the mother and focused solely on the baby. I am the first person to say there is a dearth of science when it comes to maternal mental healthcare. We need more research, and it is unfair that so many are left scrambling for help outside of our health system. But we should be seriously weighing the risk of not treating these conditions because mental illness is real and has significant impacts on the wellbeing of the pregnant person and baby.
SSRIs are not new drugs – they’ve been on the market for more than 30 years, and if there is a widespread epidemic of the harms that the FDA panel claimed, it is not substantiated in the data. So let’s not apply an inconsistent standard towards SSRIs in pregnancy. Their comments that we need more data is the last slide or nearly every scientific discussion – of course, we need more robust data. That shouldn’t seed unnecessary doubt and leave patients and their doctors in a limbo on how best to treat these conditions.
We need the right treatment, for the right patient, at the right time. In this moment when trust in government institutions is at a low, sowing further doubt is the last thing my patients deserve. The American public needs to know they are getting the highest quality guidance; in the absence of that, lives are at risk.
As we’ve seen in the case of vaccines, official federal guidance has been rapidly changing and is often out of alignment with the best science available. Professional medical societies are currently filling the void where government guidance falls short. If this panel on SSRIs is a harbinger of what’s to come, this might become the case for SSRIs in pregnancy. The American Psychiatric Association and American College of Obstetrics and Gynecology have expert guidance on treatment, including psychotropic medications.
As for my patient, we evaluated the data – doctor and patient – and together she made an informed decision weighing the risks and benefits to start an SSRI along with therapy. Her mood and anxiety improved, and she had a safe delivery. Both mother and baby are thriving.
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Dr Sunny Patel is a psychiatrist at Georgetown’s Thrive Center for Children, Families, and Communities. He recently served as senior adviser at the Substance Abuse and Mental Health Services Administration