A Howard University scientist sued the U.S. Food and Drug Administration on Monday for failing to act on his six-year-old petition seeking a warning label for two classes of common antidepressant drugs about the potential for persistent sexual side effects.
In a complaint filed in Washington, D.C. federal court, Antonei Csoka accused the FDA of “unreasonably delaying issuing a decision in light of the nature and extent of the public health interests addressed in the petition.”
Csoka, along with 21 other scientists, filed the so-called citizen petition with the FDA in May 2018. They urged the agency to update the warning labels of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Current warning labels for these drugs, which include Eli Lilly’s Prozac, Viatris’s Effexor, and their generic versions, warn of sexual side effects during use. The petition highlighted research showing that these side effects, including loss of sexual function and pleasure, can persist even after discontinuing the drugs.
The FDA declined to comment on the lawsuit. Csoka’s lawsuit argues that the FDA violated its own regulations, which generally require a response to citizen petitions within 180 days. The agency issued an interim response in November 2018, stating that the petition required further review, but has not made a decision or taken any actions requested in the petition since then.
European and Canadian regulators have since warned that SSRIs and SNRIs can cause persistent sexual side effects. “The FDA needs to act in a timely way to inform the public about the risks associated with the use of these drugs,” said Michael Kirkpatrick of Public Citizen Litigation Group, a lawyer for Csoka. “The FDA’s failure to act exposes consumers to potentially life-long harm.”
The case is Csoka v. Food and Drug Administration, U.S. District Court for the District of Columbia, No. 1:24-cv-01486.
