The U.S. Food and Drug Administration is focusing on the safety of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. An expert panel reviewed SSRIs, including fluoxetine and sertraline, with most members previously questioning their safety. Some studies cited were criticized for lacking appropriate controls, leading to uncertainty about whether SSRIs or other factors caused health issues. The risks of untreated depression were often overlooked, despite their significant impact on maternal and child health. Experts worry that the panel's conclusions may hinder access to necessary care for women.
Several panel members cited studies that lacked appropriate controls, making it uncertain whether the observed health problems were caused by SSRIs, underlying mood disorders, or other factors.
Few panelists considered the risks of SSRI use relative to the risks associated with untreated depression, which contributes to poor outcomes for children and mothers.
An FDA spokesperson indicated the panel was part of the agency's efforts to apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight.
Healthcare professionals expressed concern that the panel's findings could ultimately prevent women from getting the care they need during and after pregnancy.
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