FDA Should Require Balanced, Evidence-Based Pregnancy Warnings for Common Antidepressants
Use of Prozac, Effexor XR, Similar Drugs During Pregnancy Should Be Considered Only If their Potential Benefits Outweigh Their Potential Risks Taking Into Account the Risks of Untreated Mental Illness
WASHINGTON, D.C. – Public Citizen submitted a petition late on Friday to the U.S. Food and Drug Administration (FDA) urging the agency to require new class-wide pregnancy warnings in the product labels of serotonin reuptake inhibitor (SRI) antidepressants: selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).
“SRIs cross the placenta and are found in fetal tissues. Therefore, it is critical that the labeling of these drugs convey a balanced, evidence-based information about their potential risks. This will help expectant mothers and their clinicians make informed decisions regarding their use during pregnancy,” said Azza AbuDagga, Ph.D., health services researcher at Public Citizen’s Health Research Group, who prepared the petition.
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). Based on a 2016 FDA-funded study, at least 6% of U.S. 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 U.S.
Specifically, the petition requests updated warnings regarding the risk of poor neonatal adaptation syndrome (PNAS) in newborns exposed to SRIs during the third trimester of pregnancy. The enhanced warnings emphasize the common occurrence of this potentially serious risk and that it may extend beyond the first two weeks of life.
The warnings 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. Signs of PNAS in SRI-exposed newborns include breathing problems, feeding difficulty, vomiting, low blood sugar levels, irritability, constant crying, temperature instability, or seizures.
The petition also requests a new warning indicating that concomitant use of SRIs with the sedative drugs benzodiazepines, such as diazepam (Valium and generics), or other central nervous system depressants should be avoided in the third trimester of pregnancy because it can exacerbate PNAS in neonates.
The petition calls on the FDA to require companies that market SRIs to conduct a comprehensive post-marketing safety surveillance study to assess the short- and long-term outcomes of prenatal SRI use in exposed newborns. Until evidence from such a study and others becomes available, 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.
If use of antidepressants during pregnancy is deemed by expectant mothers and their clinicians to be necessary – especially in instances in which SRIs were used before pregnancy – it is best to use the smallest effective dose for the shortest period 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 conditions, according to the petition.
“Our requested labeling changes are based on the current research evidence. Although emerging evidence from animal studies suggests that use of SRIs during pregnancy may be linked to neurodevelopmental outcomes (such as emotional problems) in the exposed offspring, these findings have not been adequately confirmed by the limited available neuroimaging and observational studies in humans. Therefore, it is important to exercise caution with the use of SRIs during pregnancy until further research provides more conclusive evidence. At the same time, it is essential to treat mental illness during pregnancy whenever it occurs, because failing to do so causes well-documented harms for expectant mothers and their offspring,” added AbuDagga.
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 solely at improving public health.