FDA Panel's "Misinformation" on Antidepressant Use in Pregnancy

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Brian Lehrer: Brian Lehrer on WNYC. Now, to our Health & Climate Tuesdays section of the show today, on the health side, and as we've been doing since the beginning of the year, focusing very much on health and climate stories related to changes that are taking place under the Trump administration. A recent expert panel organized by the Food and Drug Administration cast doubt on the safety of antidepressant medications used during pregnancy, specifically the SSRIs, as they're known. Celexa, Lexapro, Zoloft, Prozac, Paxil.
So many of those are SSRIs, which stands for selective serotonin reuptake inhibitors. No, I didn't memorize that. I read it off a page. The drugs are largely considered safe for pregnant people among healthcare providers. The panel itself sparked backlash from several medical organizations, including the American College of Obstetricians and Gynecologists and what they call the National Curriculum for Reproductive Psychiatry.
While one in five pregnant women and new parents in this country suffer from anxiety and depression, roughly 6% to 8% of pregnant women are prescribed SSRIs. That's the rough percentage of people taking them when they're pregnant. The FDA is now weighing whether or not to add to the warning labels on this class of medications, which may influence how patients and doctors consider the use of SSRIs in pregnancy, a warning label that's pregnancy-specific.
Let's talk about this. Our guest is the chair of one of those organizations that has spoken out sarcastic, or not sarcastically but skeptically, and fact-checked the panel. It's Dr. Lauren Osborne, vice chair of clinical research at the Department of OBGYN at Weill Cornell Medicine and chair of the National Curriculum in Reproductive Psychiatry. Dr. Osborne, thanks so much for coming on. Welcome to WNYC.
Dr. Lauren Osborne: Thanks so much for having me. I'm really pleased to be here.
Brian Lehrer: You want to just explain your group a little bit. People may hear the word "curriculum" and think, "Oh, this is what they teach in a class." What is the National Curriculum in Reproductive Psychiatry?
Dr. Osborne: Yes, it's a group that's brought together by about 60 psychiatrists, all working in academic centers. We came together to really try to lay the foundation of evidence-based treatment of women at times of reproductive hormonal transition. The reason we needed to do that is that learning about mental illness at times of reproductive hormonal transition, so that means pregnancy, postpartum, perimenopause and the menstrual cycle isn't required knowledge for psychiatrists in general training or obstetricians in general training. We wanted to provide learning materials for people who wanted to become experts in this field, which we think is vital for the treatment of women at this time.
Brian Lehrer: What is the current prevalence of pregnant women on SSRIs?
Dr. Osborne: Well, the prevalence shifts. We're talking right now about higher rates than we've had ever before. I've seen various numbers out there. Usually, about 5% is what most people would cite now. About 13% is the prevalence of depression nationwide. Then in pregnancy and postpartum, that can rise. Particularly in the postpartum period, we have rates of up to about 20%. The majority of people are not using medications in pregnancy. We reserve that for people with moderate-to-severe depression.
Brian Lehrer: Is there a typical patient profile that is pregnant women with depression or high-enough levels of anxiety who are on these drugs, and those who aren't?
Dr. Osborne: Well, what we recommend is for everybody who has mild-to-moderate illness and has access to non-pharmacological treatment, that you'll want to try that first. Because even though these drugs are quite low risk in pregnancy, anything you do bears some level of risk. If you have mild-to-moderate illness, in other words, it's not really affecting your functioning, it's symptoms that you have but you can control and get through your days, then we're going to recommend psychotherapy, addition of something like prenatal yoga, social support, but not everybody has access to that.
Insurance is a real problem with reimbursement for mental health treatment. Even people with milder illness may sometimes resort to a drug because they don't have access to other forms of treatment. When we get into the moderate-to-severe range, people whose functioning is affected, they're having issues with their relationships, issues with work, issues with getting through their day, that's the level at which we would usually recommend medications, or somebody who's had a really severe history in the past. Let's say suicide attempts or hospitalizations in the past, we may want to make sure that they're protected during pregnancy.
Brian Lehrer: Listeners, we can take your calls and texts on a few tracks here if you've used SSRIs during pregnancy, as we start to talk more about the actual risks and benefits and why our guest is skeptical of the findings of this Trump-era FDA panel. If you've used SSRIs during pregnancy, help us report this story. What did it mean to you to have access to that medication, or, for that matter, were you taking SSRIs, and you think it was bad for you during pregnancy or for the fetus in retrospect? 212-433-9692. Doctors and other medical providers, if you have experience prescribing SSRIs in pregnancy or helping pregnant women manage them, we invite your calls and texts to 212-433-WNYC, 212-433-9692.
Megan in Fair Haven, we see you. You'll be first up with your personal experience, but let's just focus a little bit more on what just happened. This panel, which featured the Trump-appointed FDA Commissioner Marty Makary, also featured a majority of doctors and researchers who said that SSRIs in pregnancy can have serious health risks, including autism spectrum disorder. Let's take a listen to that claim from Dr. David Healy, professor of psychiatry at Bangor University in the United Kingdom, speaking at that hearing on July 21st.
Dr. David Healy: Any drug that causes birth defects will cause autistic spectrum disorder, also ASD. This led me and colleagues to begin to put together an article on links between SSRIs and ASD. There was loads of evidence 10 years ago or more for this. Plus, in addition, we found that mothers who are taking SSRIs during pregnancy have a tenfold greater risk of having a baby with fetal alcohol syndrome. The Canadian guidelines for SSRIs now say SSRIs cause alcohol use disorder. The labels of SSRIs, however, don't say this.
Brian Lehrer: That from one doctor at the Trump administration FDA panel. Dr. Osborne, I think you are very skeptical of that analysis. In fact, I think your group has accused the panel of misrepresenting evidence and spreading misinformation. What's your view?
Dr. Osborne: Absolutely, I am skeptical of those comments. I think we have to understand this in the context of what risks drugs confer and what risks illness confers. A lot of the early studies that were done on SSRIs compared women with depression taking SSRIs to perfectly healthy women who did not have depression. Some early studies did find relationships with, for example, birth defects or autism, but these were not appropriate comparison groups. The control group did not have depression.
When we delve a little deeper, as more recent studies have done, we find that the majority of the risk that was earlier attributed to SSRIs is actually attributed to things that are different about women with depression. For example, women with depression genetically confer a higher risk for autism in their children. In addition, there are a lot of things that are different about women with depression in terms of their prenatal care, their other medical comorbidities. Those things may be conferring risk. The more recent studies that have separated out the risks of the illness from the risks of the drug itself find that there's no credible evidence for a causative role of SSRIs in autism or in any major congenital anomaly.
Brian Lehrer: Because I'm not sure if I got all the details right, are you saying that depression is a risk factor for autism in the baby?
Dr. Osborne: Absolutely. Maternal psychiatric illness is a known risk factor for autism disorders. Depression is also risk for a host of other things that can happen to children. For example, preterm birth and low birth weight, poor prenatal care engagement, increased substance use, those are all risks associated with depression itself.
Brian Lehrer: Just to one more thing before we go to some calls in that clip that doctor cited, Canadian guidelines for SSRI, which now say SSRIs can cause alcohol use disorder. What is that based on, if anything, to your knowledge?
Dr. Osborne: Yes, those Canadian guidelines do not state that they cause alcohol use disorder. It is true that people with depression have higher rates of alcohol use disorder. Therefore, you will find higher rates of people with alcohol use disorder taking SSRIs because they have depression, but there's no causative link that's been shown.
Brian Lehrer: We're talking in this segment about the possibility of putting a use warning on common antidepressants, the ones known as SSRIs, for use in pregnancy based on an FDA panel convened under the Trump administration. Let's hear one woman's story. We have lots of lines. We'll get to a number of your stories here and more of the policy debate and whether the simple fact of a warning label would decrease use or otherwise present dangers. We'll get to that question. Megan in Fair Haven, you're on WNYC. Thank you for calling in.
Megan: Yes, thank you so much for having me. I could not feel more passionately about this subject, so I'm thrilled you're doing a segment on it. In 2018, when I had my first child, I was taking Zoloft when I got pregnant. I had been on Zoloft for anxiety and depression at that point for 15 years. Long history of anxiety, panic attacks, et cetera. When I got pregnant, I was advised by my OBGYN at the time to consider titrating off my medicine during the pregnancy, and so I did. It was my first pregnancy.
I will also say that every woman who takes an SSRI during pregnancy has some measure of guilt about it already. It is a very charged thing for women. I listened to my doctor, and I came off my medicine completely. When I gave birth, I wound up in a major crisis. I developed postpartum psychosis as a result of being off my medication. Never in my life have I ever experienced anything like that. It was absolutely terrifying.
It resulted me having no relationship with my daughter for the first six weeks of her life because I was just so focused on getting my mental health back. For my second pregnancy, I was told to stay on my medicine, which I did. Long story short, not only was I completely fine with no issues during the pregnancy afterwards, postpartum, my son was totally fine and healthy. I just wanted to bring that to the table.
Brian Lehrer: Thank you very much. Well, a sample size of one, Dr. Osborne, but a comparison of pregnancy with and without the medication that she otherwise needed.
Dr. Osborne: Absolutely. We know that about 60% to 70% of women who have been on medications for depression prior to pregnancy will relapse if they are taken off the medications. It's a sample size of one here, but a much larger sample size nationwide.
Brian Lehrer: Diana in Bay Ridge, I think, had a different experience. Diana, you're on WNYC. Hello.
Diana: Hi. I've called in before, but this is the first time my child has called in, a five-week-old baby. I had been on Lexapro for anxiety for years, at least 10 years. I heard about how all the things you've talked about, how it's the risks for the baby. Knowing I wanted to get pregnant a year early, I talked to my doctor about weaning off. I had many people. It's hard to wean off these drugs. I was very anxious. I talked to a doctor, and she's like, "You have my blessing."
She's like, "There's risks, but being pregnant is scary. There's risks to everything." Like what the previous caller said, it's very emotional, the idea that you're not doing what's best for your baby. She said, "You have my blessing to stay on it," and so I decided to stay on it, had a successful pregnancy. The baby's great. The one thing I will say is the nurse told my wife that when-- I had a C-section. When the baby was born, he was very sleepy and had fluid in his lungs. He thought perhaps that was part of the result of the fact that I was on Lexapro. They'd seen that before with other women.
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Brian Lehrer: Yes, so you were told that in the hospital. Have you heard that before, Dr. Osborne?
Dr. Osborne: There are some risks to these drugs, of course. Anything you take in pregnancy is a risk. Fluid in the lungs, probably more likely to be due to the C-section than to the SSRIs. There is an adaptation syndrome that can happen in babies born to moms taking SSRIs. What's important to remember, though, is we're comparing that risk against the risk of going off the medication. Mental health conditions account for about 23% of pregnancy-related deaths, one of the leading causes. It's not that there's no risk. Anybody with an illness in pregnancy who takes a medication, there's some risk, but we have to weigh the risks against each other.
Brian Lehrer: By the way, Diana, I heard your kid in the background there. Another baby makes their radio debut on The Brian Lehrer Show. Do you want to say the name?
Diana: His name is Lee. He's very happy to be on the radio. I'm sorry. Just to clarify, my wife came in. It was that he was sleepy. The fluid in the lungs, your guest is right, that was related to C-section. The fact that he was sleepy when he came out, the nurse said that. She thought that was because of Lexapro.
Brian Lehrer: Diana, thank you very much. Dr. Osborne, what would the upshot of this Trump administration FDA process be? Would it be a clause on a warning label that says, "Use with caution if you're pregnant," "Consult your doctor," or something stronger than that, or banning it for use in pregnant women? What are they potentially heading towards here?
Dr. Osborne: Yes, they haven't specifically said what the object is, but one possibility is something like a black box warning, where they put a warning saying, "This medication is unsafe to use in this population." As I said, the evidence doesn't support that. What that would mean for women is we've heard from both of our callers that there's a lot of guilt and shame around this. A lot of people, reluctant to take medications even if they need it. I think putting a warning like that that isn't based in evidence would do more harm in that realm, causing more women to decide that they're too scared to take these medications in pregnancy when the bulk of the evidence supports their use.
Brian Lehrer: I'm reluctant to play this next clip, so let me just say that out loud before I do, because we never want to spread what may be misinformation or disinformation on this show. In this case, because the whole frame is your organization shouting out and identifying what you think was misinformation in this FDA panel that could have major consequences for the availability of SSRIs for pregnant women, I'm going to play one more one-minute clip from the panel itself.
Listeners, I think you get the context there of why we're playing it with Dr. Osborne's presence, because her organization's press release, the National Curriculum in Reproductive Psychiatry, highlighted the remarks of psychologist Roger McFillin, executive director of the Center for Integrated Behavioral Health, as that organization is called, as being particularly misleading. Here's about a minute of what he had to say on that panel.
Roger McFillin: I think there's an awakening right now in American culture where there is a valid distrust of institutions. This is an institution that you want to question because many of the people that I talk to never received informed consent. It's too late by the time you walk into Dr. Urato's office. You've already exposed that developing baby to an SSRI. What happens is we're really good at putting people on drugs, and we're really bad at getting people off drugs.
Many women feel coerced. Some difficult questions. Why are we prescribing these drugs at a rate so accelerated compared to men? Is that because this underlying mental illness that we're trying to control for, when we don't test for, when there's no objective testing, it just is more prevalent in women, or are women just naturally experiencing their emotions more intensely, and those are gifts?
Brian Lehrer: I imagine it's that last part where you really think he went off the rails, but you tell me.
Dr. Osborne: Yes, I think the implication of the statement is that the higher rates of anxiety, depression that we have in women, it's about twofold higher the depression rate in women than in men, that that's a gift of emotional sensitivity. I would challenge the speaker to find a woman who has depression that's affecting her functioning in life and ask her if she thinks that it's a gift. It's a known fact that the rates of anxiety and depression are higher.
A lot of it has to do with our exposure to reproductive hormonal fluctuations, which we see that those rates being higher during the reproductive years, but not in the post-reproductive years. There's a real biological basis for these differences. We can't treat this as if it's a gift rather than an illness. We wouldn't say, "You have gestational diabetes. That's a gift. Don't take insulin," but we're willing to say that about depression because people think about the brain as something different from the body.
Brian Lehrer: To the beginning of his statement, and I'll get your take on this, and then we're out of time, a lot of people will identify with what he said and think that is not disinformation when he said, "I think there's an awakening right now in American culture, where there is a valid distrust of institutions, and this is an institution that you want to question," I guess he means a pharmaceutical antidepressant medication industry, "because many of the people that I talk to never received informed consent."
You know a lot of people out there. You don't have to be a conspiracy theorist to think that the pharmaceutical companies are trying to push these drugs on too many people. Let's look for talk therapy treatments first, and all of that. What is your take on the distrust of institutions, and how valid that is, and how that leads into correct rates of use or overuse or, you might argue, underuse of antidepressant medications in pregnancy?
Dr. Osborne: Yes, I think it's a complicated issue. We are in a moment of distrust of institutions. Certainly, the pharmaceutical industry has a lot to answer for. I don't support a lot of the practices of the pharma industry. I think we also have to separate it out, the idea of informed consent. Why do we need informed consent for this medication, but not for other medications that are used?
Again, I think that's that bias about mental illness coming in. We don't use informed consent as in a formal written consent for other types of medications. While I acknowledge that there may be doctors out there who are prescribing inappropriately, in fact, that's why we came up with our organization to provide evidence-based reasons for doing this, we also have to set it in the context of the system. Sure, if we could get everybody better with psychotherapy, that would be great.
When people have moderate-to-severe illness, that's not enough. In addition, most people do not have access to psychotherapy. Medical insurance, rates of reimbursement for psychiatric conditions, and psychiatric treatments are much lower than for other types of treatments. That puts people in a bind if I need to do something to treat my depression and I don't have access to that lower level. If they have a higher level of symptoms, they really need that medication.
Brian Lehrer: Dr. Lauren Osborne, MD, is vice chair of clinical research at the Department of OBGYN at Weill Cornell Medicine and chairman of the group called the National Curriculum in Reproductive Psychiatry. Thank you so much for joining us today.
Dr. Osborne: Thanks so much. It was a pleasure to be here.
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