Antidepressant meds for women may be getting a new warning label.
On July 21 of this year, experts from around the world convened at the U.S. Food and Drug Administration (FDA) headquarters outside Washington, DC to debate whether a “black box” warning label should be added to antidepressants when taken by women during pregnancy.
Many proponents of the new warning label believe the class of antidepressant drugs called selective serotonin reuptake inhibitors (SSRIs) cause significant birth-defect risks to the developing fetus, and in some cases, risks to the mother. Thus, a stricter warning label is being considered for these drugs.
Opponents of this new warning label believe it represents a measure that is not fully thought out. They believe adequate safety protocols have already been in place, and that the new label may scare off women and their doctors from medications they need to manage anxiety or depression.
A decision on whether to add the warning label is expected soon. Below are some of the issues to consider.
In the room where it happened
First, a bit of an inside scoop: I personally know one of the scientists who was invited to give their opinion on the topic at the two-hour FDA debate in July.
This physician spoke in favor of the concept that medications during the perinatal period can be extremely helpful for both the mother and the infant, if used judiciously.
My opinion on “black box” warning labels
It’s true that warning labels are warranted in some cases, when the science supports it. And yes, warning labels have no doubt kept some people safe who otherwise may have become ill from a medication.
But “black box” warning labels need closer review. My concerns are that some black box warnings may lead to worsening illness when a person doesn’t take a needed medication because of their fear of the side effects listed on the label.
There is always a risk/benefit analysis to consider when you take medications. But when a strongly worded warning label gets applied, that may quash the careful consideration and deliberation needed. It may steer people away from a treatment they need.
Safeguards in place
Using available data, we already have in place risk levels A through D, with A being the lowest risk, and D being the highest, for psychiatric medications that pregnant women take for depression or anxiety. Using that scale, a mother-to-be can make an informed decision alongside her doctor about which medication may have the lowest risk yet will still be therapeutic.
That protocol has provided guardrails so that pregnant women and new mothers can safely and responsibly navigate the risk with oversight from their doctor.
My time in the OB/GYN world
Early in my career, I trained in an OB/GYN residency program. I saw first-hand how pregnant women and new mothers were coping—and sometimes not coping—with mental health struggles. I remember how difficult it was for some mothers to take care of themselves and their newborns.
Many had been through very difficult pregnancies because they had gone off their medications, therapy, or other aspects of treatment. During pregnancy, mother and child are very much a unit. It’s a package deal in every respect, so it’s only logical that a mother’s mental and physical well-being is going to affect their child’s health. I witnessed that pre- and post-delivery.
Those issues will continue after the child is born. In fact, I treated a new mother recently who was dealing with severe anxiety and had only started getting treatment for it late in her pregnancy.
This patient had severe perinatal (referring to the time before and after birth) anxiety and was having a very difficult time bonding with her newborn. Had she started a medication earlier in her pregnancy and followed options such as cognitive behavioral therapy, her post-partum period with her child may have been different.
Another area where antidepressants and SSRIs can be beneficial is when women have depression or another mental condition and substance use disorder (SUD). This happens a lot. Research has shown that among people with a mental illness, such as depression, anxiety, or trauma, around a third of them also have SUD.
In my own experience in addiction treatment, we see many women with SUD—including perinatal women—who are also battling depression. When we treat these women with antidepressants, as we usually do, they have a better chance at recovery from their addiction. And we often see better health outcomes overall for the mother and child.
We’ve seen this downside with a warning label before
There’s a precedent that can help us navigate the current debate on antidepressants. It also involved adding a “black box” warning label to the SSRI class of antidepressants. (By the way, SSRIs include brand names that are still very much with us, including Lexapro, Prozac, and Zoloft.)
When it went into effect in 2004, it targeted certain SSRIs thought to be increasing the risk of suicidal thoughts and behaviors in adolescents with depression.
I had just started my psychiatry career and immediately encountered many parents who were scared off by the warning label. Many refused to allow their teenagers to take depression medications, even if the risk of doing so was low and their kids were benefitting significantly from the medications.
I understand the fear of side effects, and I have them about medications, too. But in countless circumstances back in 2004 and to this day, those SSRI concerns around suicidal thoughts and behaviors warranted a more nuanced approach.
Some commonsense recommendations
Here are some ways to help women stay safe if they’re considering getting pregnant, or are pregnant, but need to continue their psychiatric medication:
- Work with your OB/GYN and your behavioral health provider to develop a comprehensive plan for a safe pregnancy and post-partum period.
- Be sure your OB/GYN and behavioral health providers are collaborating to help keep you and your baby safe and healthy. This is key.
- Check with your providers about a medication that has a safer profile versus stopping the medication altogether during your pregnancy.
- Continue with or start therapy for your depression. Therapy can be a very complementary part of your treatment plan during and after your pregnancy.
- Remember, always, that depression is a serious mental health condition that is treatable and manageable. You and your newborn deserve good mental health.
Final thoughts
Black box warning labels can promote black-and-white thinking in medical decision making. They may also have unintended consequences that can pose inadvertent risks to a person’s health.
In my opinion, careful thought and the weighing of benefits and risks should remain with the individual and their provider.
