Research has long indicated that antidepressant users are at risk of serious sexual problems that may persist indefinitely, even after stopping the drugs. Citizens Commission on Human Rights says FDA needs to act now.
A lawsuit was filed in the U.S. District Court for the District of Columbia claiming the U.S. Food and Drug Administration (FDA) has failed to take final action on a 2018 citizen petition urging an updated warning on antidepressants labeling for the serious risk of persistent, worsening, or newly emerging sexual side effects after stopping use of the drugs. One of the petition’s signers is suing the FDA to force it to act, a step that Citizens Commission on Human Rights (CCHR) commends.
“The devastating sexual side effects from antidepressants, harming the sex lives of an untold number of the 45 million Americans taking the drugs, should have been addressed as a public health concern years ago by the FDA,” said Anne Goedeke, president of the CCHR National Affairs Office in Washington, DC. “The FDA needs to act now, without further delay.”
In his lawsuit, Antonei B. Csoka, Ph.D., an assistant professor in the anatomy department at Howard University, says that the FDA has failed to follow its own regulations for granting or denying the petition. Csoka is seeking a court order requiring the FDA to act.
The lawsuit states that antidepressant labeling warns of sexual problems that may be experienced while taking antidepressants, but “current labeling in the United States does not adequately convey the risk of broad, severe, and potentially permanent post-treatment changes to sexual function.”
The antidepressants at issue are selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), the two most commonly prescribed classes of antidepressants. Csoka has researched post-SSRI sexual dysfunction since 2004.
“The devastating sexual side effects from antidepressants, harming the sex lives of an untold number of the 45 million Americans taking the drugs, should have been addressed as a public health concern years ago by the FDA.” — Anne Goedeke, CCHR National Affairs Office.
The citizen petition, which was also published in the International Journal of Risk & Safety in Medicine in 2018, references numerous studies on sexual dysfunction from antidepressants and its debilitating effect on patients’ quality of life. The 22 petition signers call on the FDA to strengthen the warning on antidepressants labeling to include the risk of persistent sexual side effects after the use of antidepressants has stopped and to require SSRI and SNRI manufacturers to send a “Dear Health Care Provider Letter” to inform psychiatrists, family practitioners and other prescribers about the risk.
Csoka’s lawsuit says that after similar petitions were filed in 2018 with drug regulatory agencies in Europe and Canada, warnings were updated by the European Medicines Agency in 2019 and by Health Canada in 2021 to reflect the risk. However, the FDA has yet to take final action.
Research variously indicates that while taking antidepressants, 25%-80% of patients encounter sexual difficulties they had not experienced before taking the drugs, and the symptoms can persist indefinitely, even after the drugs are no longer taken.
Researchers urge psychiatrists and other prescribers to adequately disclose these risks to patients before prescribing antidepressants, so patients can make fully informed decisions about the drugs.