{"id":3180,"date":"2024-06-03T10:00:00","date_gmt":"2024-06-03T15:00:00","guid":{"rendered":"https:\/\/www.cchrstl.org\/wordpress\/?p=3180"},"modified":"2024-07-14T05:38:08","modified_gmt":"2024-07-14T10:38:08","slug":"cchr-commends-lawsuit-filed-over-fdas-failure-to-act-on-citizen-petition-to-update-antidepressant-labeling-for-persistent-sexual-problems","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2024\/06\/03\/cchr-commends-lawsuit-filed-over-fdas-failure-to-act-on-citizen-petition-to-update-antidepressant-labeling-for-persistent-sexual-problems\/","title":{"rendered":"CCHR Commends Lawsuit Filed over FDA\u2019s Failure to Act on Citizen Petition to Update Antidepressant Labeling for Persistent Sexual Problems"},"content":{"rendered":"\n

<\/em>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.<\/em><\/h2>\n\n\n\n

by CCHR National Affairs Office<\/a><\/em><\/p>\n\n\n\n

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.\u00a0 One of the petition\u2019s signers is suing the FDA to force it to act, a step that Citizens Commission on Human Rights (CCHR) commends.<\/p>\n\n\n\n

\u201cThe 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,\u201d said Anne Goedeke, president of the CCHR National Affairs Office in Washington, DC.\u00a0 \u201cThe FDA needs to act now, without further delay.\u201d<\/p>\n\n\n\n

In his\u00a0lawsuit<\/a>, 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. \u00a0Csoka is seeking a court order requiring the FDA to act.<\/p>\n\n\n\n

The lawsuit states that antidepressant labeling warns of sexual problems that may be experienced while taking antidepressants, but \u201ccurrent labeling in the United States does not adequately convey the risk of broad, severe, and potentially permanent post-treatment changes to sexual function.\u201d\u00a0<\/p>\n\n\n\n

The antidepressants at issue are selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), the two most commonly prescribed classes of antidepressants.\u00a0 Csoka has researched post-SSRI sexual dysfunction since 2004.\u00a0<\/p>\n\n\n\n

The\u00a0citizen petition<\/a>, which was also published in the\u00a0International Journal of Risk & Safety in Medicine<\/em>\u00a0in 2018, references numerous studies on sexual dysfunction from antidepressants and its debilitating effect on patients\u2019 quality of life.\u00a0 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 \u201cDear Health Care Provider Letter\u201d to inform psychiatrists, family practitioners and other prescribers about the risk.<\/p>\n\n\n\n

Csoka\u2019s 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.\u00a0 However, the FDA has yet to take final action.<\/p>\n\n\n\n

Research variously\u00a0indicates<\/a>\u00a0that 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.<\/p>\n\n\n\n

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.<\/p>\n","protected":false},"excerpt":{"rendered":"

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. Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"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.","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2,3],"tags":[18,108,62,36,98],"class_list":["post-3180","post","type-post","status-publish","format-standard","hentry","category-big-muddy-river-newsletter","category-press-releases","tag-antidepressant","tag-fda","tag-informed-consent","tag-side-effects","tag-ssri"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p6NMpC-Pi","jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/3180","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/comments?post=3180"}],"version-history":[{"count":0,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/3180\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/media?parent=3180"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/categories?post=3180"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/tags?post=3180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}