Public Citizen Petitions FDA To Improve Pregnancy Warnings for Common Antidepressants

On Nov. 14, 2025, Public Citizen filed a petition with the Food and Drug Administration (FDA) urging the agency to require balanced, evidence-based pregnancy warnings in the product labels of serotonin reuptake inhibitor (SRI) antidepressants: selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).[1]

Examples of SSRIs include citalopram (CELEXA and generics), fluoxetine (PROZAC and generics), paroxetine (PAXIL and generics) and sertraline (ZOLOFT and generics). Examples of SNRIs include desvenlafaxine (PRISTIQ and generics) and venlafaxine (EFFEXOR XR and generics).

According to an FDA-funded study, at least 6% of American pregnant women are treated with SSRIs alone, indicating that at least 215,000 fetuses are exposed to these antidepressants during pregnancy each year in the United States.[2]

Notably, Public Citizen’s Health Research Group has designated almost all SSRIs as Limited Use because they have a boxed (prominent) warning about the increased risk of suicidal thoughts and behaviors in children, adolescents and young adults.[3],[4] These drugs also are associated with other serious adverse effects, including seizures, abnormal bleeding, and a rare but potentially fatal condition called serotonin syndrome.

We have designated all SNRIs as either Limited Use or Do Not Use, depending on whether they are associated with more adverse effects than alternative medications.

About serotonin and SRIs

Serotonin is a neurotransmitter that appears early in fetal development and has a broad role in the development of the brain and other organs.[5] It also is believed to impact mood, emotions, learning, memory, attention and sleep, among other functions. More than 98% of serotonin is present outside the central nervous system and is believed to play a role in regulating key physiological processes, such as calcium metabolism, energy balance, gastrointestinal movement and vascular resistance, among many other functions.[6]

SRIs are synthetic psychotropic drugs that increase extracellular serotonin concentrations by selectively blocking serotonin reabsorption at the plasma membrane serotonin transporter.[7] These drugs are used to treat depression, anxiety and other mental health conditions (such as panic disorder, phobias and obsessive-compulsive disorder).[8]

In 1987 the FDA approved the SSRI fluoxetine (PROZAC, now available in generic). Since then, the agency has approved other SSRIs and SNRIs as well.

SRIs cross the placenta and are found in amniotic fluid and fetal tissues. The placental transfer of these drugs is generally substantial, according to an often-cited study that examined cord (neonatal plasma) and maternal drug concentrations of SSRIs and the SNRI venlafaxine at birth and on day three after birth.[9]

Due to their high placental permeability and potential to modify serotonin signaling and increase serotonin levels in the brain and other organs, it is not implausible that SRIs could affect fetal development.[10]

Public Citizen’s requested SRI pregnancy warnings[11]

Potential harm to neonates after birth

The petition requests enhanced warnings regarding the potential risk of poor neonatal adaptation syndrome (PNAS, also known as neonatal abstinence syndrome). This risk refers to the postnatal withdrawal symptoms seen in newborns who are exposed to SRIs in the third trimester of pregnancy.

PNAS manifests as a constellation of variable transient cardiovascular, respiratory, central nervous system, gastrointestinal or motor adverse reactions.[12] Specific signs include breathing problems, feeding difficulty, vomiting, low blood sugar levels, irritability, constant crying, temperature instability or seizures. These signs can occur immediately after birth.

The requested warnings highlight that available evidence suggests this complication affects up to 30% of neonates exposed to these drugs during the third trimester. There is evidence that SRI-induced PNAS can be dose dependent and may not be limited to the first two weeks after birth.

The requested warnings also recommend advising pregnant patients taking SRIs to deliver in a hospital to ensure that management by neonatology experts will be readily available upon delivery, when needed.

Furthermore, the petition requests a new warning indicating that concomitant use of SRIs with benzodiazepines (sedative drugs; such as diazepam [VALIUM and generics]) or other central nervous system depressants in the third trimester of pregnancy should be avoided because it can exacerbate PNAS in neonates.

Balancing the benefits and risks of SRI use during pregnancy

Untreated maternal depression during pregnancy is associated with profound negative effects on the mother and the baby. Thus, the petition emphasized that it is important to treat maternal mental illness (including depression) whenever it occurs.

Although some animal studies have linked prenatal SRI exposure to neurodevelopmental problems (such as depression and anxiety) in the offspring, human research is still limited and inconclusive about this risk. Therefore, the petition asks the FDA to require SRI manufacturers to conduct a comprehensive post-marketing safety surveillance study to examine both short- and long-term outcomes of prenatal exposure to SRIs.

Until evidence from such a study becomes available, it is important to exercise caution with SRI use during pregnancy. Therefore, to follow the precautionary principle of public health, the drug labels for SRI products need to convey that the use of these drugs should be considered in pregnancy only if their potential benefits outweigh their potential risks, taking into account the risks of untreated mental illness, the petition says. This approach would align with recommendations in clinical guidelines by the National Institute for Health and Care Excellence, which advise stopping these medications gradually during pregnancy in cases of mild to moderate depression.[13]

If use of antidepressants during pregnancy is deemed by expectant mothers and their clinicians to be necessary — especially in instances where SRIs were used before pregnancy — it is best to use the smallest effective dose for the shortest duration to minimize fetal exposure, adds the petition. In addition, it is important to monitor expectant mothers and their children more frequently.

It also is important to advise pregnant SRI users against discontinuing these drugs abruptly, because doing so may predispose them to serious withdrawal reactions or a relapse of their underlying mental health conditions, increasing their risk of suicide or impairing their ability to adhere to prenatal care, according to the petition. Clinicians should provide supportive care to mothers who decide to discontinue SRIs during pregnancy to prevent any related complications.

Public Citizen’s petition is focused solely on the use of SRIs during pregnancy, rather than in the general population. The petition was not in any way influenced by the positions of the Make America Healthy Again (MAHA) movement or many of the views expressed at the FDA’s July 21, 2025, Expert Panel on SSRIs and Pregnancy. Like Public Citizen’s many other petitions to the FDA, this petition is grounded in the available research evidence and is aimed exclusively at improving public health.

What You Can Do

If you have a mental health condition, seek non-pharmaceutical treatment options, such as psychotherapy and physical activity, as first-line treatments. If you need antidepressant therapy and you are pregnant or planning to become pregnant, discuss this article with your clinician.

Do not stop taking SRIs without consulting your clinician, because these drugs need to be discontinued gradually under medical supervision to minimize withdrawal symptoms.
 

References

[1] Public Citizen. Public Citizen petitions the FDA to require balanced, evidence-based pregnancy warnings for serotonin reuptake inhibitors. November 14, 2025. https://www.citizen.org/article/public-citizen-petitions-the-fda-to-require-updated-pregnancy-warnings-for-serotonin-reuptake-inhibitors/. Accessed November 18, 2025.

[2] Andrade SE, Reichman ME, Mott K, et al. Use of selective serotonin reuptake inhibitors (SSRIs) in women delivering liveborn infants and other women of child-bearing age within the U.S. Food and Drug Administration’s mini-sentinel program. Arch Womens Ment Health. 2016;19(6):969-977.

[3] Drug profile for SSRIs. Last reviewed July 31, 2025. https://www.worstpills.org/monographs/view/53. Accessed November 18, 2025.

[4] Missing warnings about ‘persistent’ sexual dysfunction in labeling of common antidepressants: Public Citizen sues FDA for failure to act. Worst Pills, Best Pills News. October 2024. https://www.worstpills.org/newsletters/view/1623. Accessed November 18, 2025.

[5] Terzić T, Kores Plesničar B. Selective serotonine reuptake inhibitors (SSRI) usage during pregnancy. Psychiatr Danub. 2021;33(part III):1171-1176.

[6] Domingues RR, Wiltbank MC, Hernandez LL. Maternal serotonin: implications for the use of selective serotonin reuptake inhibitors during gestation. Biol Reprod. 2023;109(1):17-28.

[7] Olivier JDA, Akerud H, Kaihola JL, et al. The effects of maternal depression and maternal selective serotonin reuptake inhibitor exposure on offspring. Front Cell Neurosci. 2013;7(May 21):73.

[8] Ornoy A, Koren G. Selective serotonin reuptake inhibitors during pregnancy: Do we have now more definite answers related to prenatal exposure? Birth Defects Res. 2017;109(12):898-908.

[9] Rampono J, Simmer K, Ilett KF, et al. Placental transfer of SSRI and SNRI antidepressants and effects on the neonate. Pharmacopsychiatry. 2009;42(3):95-100.

[10] Campbell KSJ, Collier AC, Irvine MA, et al. Maternal serotonin reuptake inhibitor antidepressants have acute effects on fetal heart rate variability in late gestation. Front Psychiatry. 2021;12(August 16):680177.

[11] Public Citizen. Public Citizen petitions the FDA to require balanced, evidence-based pregnancy warnings for serotonin reuptake inhibitors. November 14, 2025. https://www.citizen.org/article/public-citizen-petitions-the-fda-to-require-updated-pregnancy-warnings-for-serotonin-reuptake-inhibitors/. Accessed November 17, 2025.

[12] American Psychiatric Association. Perinatal mental and substance use disorder: White paper. 2023. https://www.psychiatry.org/getmedia/344c26e2-cdf5-47df-a5d7-a2d444fc1923/APA-CDC-Perinatal-Mental-and-Substance-Use-Disorders-Whitepaper.pdf. Accessed November 18, 2025.

[13] National Institute for Health and Care Excellence. Antenatal and postnatal mental health: clinical management and service guidance. Clinical guideline. Last updated February 11, 2020. www.nice.org.uk/guidance/cg192. Accessed November 18, 2025.