Comment from Americans for Scientific Integrity

On behalf of Americans for Scientific Integrity, we write in support of this citizen petition requesting that the FDA add a boxed warning regarding pregnancy complications and potential effects on fetal brain development associated with SSRI use during pregnancy. Patients and physicians rely on FDA labeling to provide clear and complete information about potential medication risks, particularly in situations where treatment decisions affect both maternal and fetal health. Given the substantial body of basic science, animal, and human data discussed in this petition, stronger disclosure is warranted so that patients can make informed decisions about treatment during pregnancy. Clear disclosure of potential risks is essential for informed consent, especially for medications used during pregnancy where both maternal and fetal outcomes must be considered. At a minimum, if the FDA determines that the current evidence does not yet justify a boxed warning, the agency should apply a precautionary approach and update labeling to clearly inform patients that some studies have reported associations between prenatal SSRI exposure and pregnancy complications and neurodevelopmental outcomes, thereby ensuring that patients and clinicians have the information necessary for shared decision-making.