FDA examined reports of persistent sexual dysfunction tied to antidepressants — but declined stronger warnings
Critics say the FDA set too high an evidentiary bar before deciding against stronger warnings about persistent sexual dysfunction linked to antidepressants.
New internal documents reveal the U.S. Food and Drug Administration (FDA) examined reports of persistent sexual dysfunction linked to commonly prescribed antidepressants — but stopped short of strengthening warning labels.
In 2018, a citizen petition urged the FDA to update labels for selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), warning that sexual dysfunction could continue long after discontinuation.
The petition described “genital anaesthesia,” “pleasureless orgasm,” and other symptoms that could persist “for years or indefinitely” after stopping the drugs.
Under federal law, the FDA is required to respond within 180 days, but that response never came.
Years passed without any public indication that the agency had reviewed the evidence or reached a position on the issue.
In 2024, the petitioners sued the FDA to compel a formal response, but the case was dismissed on a technicality after the court ruled the plaintiffs lacked “standing,” meaning they could not show a direct, personal injury caused by the delay.
Now, newly released Freedom of Information Act (FOIA) documents reveal the FDA did in fact examine the evidence internally — but never formally communicated its conclusions to the petitioners or the public.