Prozac, Paxil, Zoloft and others cross the placenta and cab cause problems for newborns
Consumer group urges FDA to add stronger pregnancy warnings to popular antidepressants
Petition cites risks to newborns from late-pregnancy exposure to SSRIs and SNRIs
Advocates call for clearer guidance, safety studies, and careful dosingnot abrupt withdrawal
Public Citizen is pressing the U.S. Food and Drug Administration (FDA) to strengthen the pregnancy warnings on widely used serotonin reuptake inhibitor (SRI) antidepressants, arguing that current drug labels fail to adequately convey risks to newborns.
The consumer advocacy group filed a petition late Friday asking the agency to require new, class-wide warnings for both selective serotonin reuptake inhibitors (SSRIs) such as Prozac, Paxil and Zoloft and serotonin-norepinephrine reuptake inhibitors (SNRIs) like Effexor XR and Pristiq.
Azza AbuDagga, Ph.D., a health services researcher with Public Citizens Health Research Group who prepared the petition, said the science is clear that these drugs readily cross the placenta. Therefore, it is critical that the labeling of these drugs convey balanced, evidence-based information about their potential risks, she said. This will help expectant mothers and their clinicians make informed decisions regarding their use during pregnancy.
Widespread use of antidepressants during pregnancy
SSRIs are among the most commonly used medications in pregnancy. A 2016 FDA-funded study found that at least 6% of pregnant women in the U.S. take an SSRI, meaning more than 215,000 fetuses are exposed to these medications each year.
Public Citizen emphasized that its petition focuses solely on SRI use during pregnancy and is not tied to broader political movements or public debates surrounding antidepressants.
Group seeks stronger warnings about neonatal risks
A central request in the petition is the addition of more explicit warnings about poor neonatal adaptation syndrome (PNAS) a cluster of symptoms that can occur in newborns exposed to SRIs in the third trimester. PNAS can involve breathing difficulties, feeding problems, vomiting, low blood sugar, irritability, constant crying, temperature instability and, in rare cases, seizures. Public Citizen stresses that these symptoms are common and may last longer than the first two weeks of life.
To manage these risks, the petition advises that pregnant patients taking SRIs plan to deliver in a hospital where neonatology expertise is readily available.
The organization also asks the FDA to add a warning against combining SRIs with benzodiazepines or other central nervous system depressants late in pregnancy, noting that such combinations may exacerbate PNAS and pose additional dangers to newborns.
Call for long-term safety studies
Public Citizen wants the FDA to require drug manufacturers to conduct large-scale post-marketing studies assessing both short- and long-term outcomes of prenatal exposure to SRIs. Until such research is completed, the petition argues, labels should advise that these medications be used in pregnancy only when the potential benefits outweigh the potential risks, including the risks of untreated mental illness.
AbuDagga noted that while some animal studies have linked prenatal SRI exposure to neurodevelopmental issues, human research is still limited and inconclusive. It is important to exercise caution with the use of SRIs during pregnancy until further research provides more conclusive evidence, she said. 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.
Advocates urge careful dosing and against sudden discontinuation
If antidepressant treatment during pregnancy is deemed necessary especially for patients who were taking SRIs prior to conception the petition recommends using the lowest effective dose for the shortest appropriate duration, along with more frequent monitoring of both mother and child.
The group warns strongly against abrupt discontinuation, saying it can trigger severe withdrawal symptoms or a relapse of the underlying mental health condition.
Public Citizen said its request to the FDA reflects current research and aims solely to improve maternal and fetal health outcomes.
Posted: 2025-11-17 20:55:51















