May 20 (Reuters) - 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 ( LLY ) Prozac, Viatris's ( VTRS ) 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.
For Csoka: Michael Kirkpatrick and Nicolas Sansone of Public
Citizen Litigation Group
For FDA: not available
(Reporting By Brendan Pierson in New York)