SSRI Sexual Dysfunction Label Petition Was Unanswered, Suit Says

The US Food and Drug Administration has failed to address a 2018 citizen petition asking the agency to revise labeling requirements for antidepressants to better reflect post-treatment sexual side effects, a lawsuit filed Monday alleges.

The FDA hasn’t granted or denied the petition despite posting it for public comment, the complaint filed in the US District Court for the District of Columbia says.

Labeling requirements for selective serotonin reuptake inhibitors don’t currently convey “the risk of persistent, worsening, or new symptoms of sexual dysfunction after stopping use of those drugs,” the complaint filed by Howard University epigentics professor Antonei Csoka ...