FDA sued by scientist urging sexual side effects warning for widely used depression drugs

 A Howard University scientist on Monday sued the U.S. Food and Drug Administration 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 said the FDA has "unreasonably delayed issuing a decision in light of the nature and extent of the public health interests addressed in the petition."

Csoka was one of 22 scientists who filed the so-called citizen petition with the FDA in May 2018, urging the agency to require an update to warning labels of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs).

Current warning labels for the drugs - which include Eli Lilly's Prozac, Viatris's Effexor and generic versions of them - warn of sexual side effects during use. The petition said research has showed that these side effects, including loss of sexual function and pleasure, can persist after the drugs are discontinued.

The FDA declined to comment on the lawsuit.

Csoka's lawsuit said that the FDA ran afoul of its own regulations, which generally require a response to citizen petitions within 180 days. It said that the agency issued an interim response in November 2018 saying the petition required further review, but has since not made a decision or taken any actions requested in the petition.

European and Canadian regulators have since warned that SSRIs and SNRIs can have persistent sexual side effects, it said.

"The FDA needs to act in a timely way to inform the public about the risks associated with use of these drugs," Michael Kirkpatrick of Public Citizen Litigation Group, a lawyer for Csoka, said in a statement. "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.

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