Request that the FDA add a boxed warning to SSRIs to inform patients, providers, and the public that use of these medications during pregnancy has been shown to be associated with increased rates of pregnancy complications and alteration of fetal brain development | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-3956

Request that the FDA add a boxed warning to SSRIs to inform patients, providers, and the public that use of these medications during pregnancy has been shown to be associated with increased rates of pregnancy complications and alteration of fetal brain development

Documents

179

Comments

Description

OPEN

Key Dates

Comment Period OpensSep 23, 2025

Documents

Type	Title	Posted	Comments	Status
Other	SSRI listening session minutes_3-24-26	Apr 24, 2026	--

Keywords

CDER

Citizen Petition

MetroWest Medical Center

add a boxed warning to SSRIs to

inform patients, providers, and the public

that use of these medications during pregnancy

has been shown to be associated with

increased rates of pregnancy complications and

Data from Regulations.gov