Citizen petition: Sexual side effects of SSRIs and SNRIs
Open accessAbstract
The undersigned submits this petition to request the Commissioner of Food and Drugs to immediately require the addition of boxed warnings, warnings, precautions, and highlights of prescribing information to the product label for all selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) products, including branded and generic formulations.These include, but are not limited to, citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fl uoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), and vortioxetine (Trintellix). A. Action requestedRequire the immediate revision of all SSRI and SNRI product labels (including branded and generic formulations) to warn of serious and severe risks, as follows: 1. Add WARNINGS, PRECAUTIONS, and HIGHLIGHTS OF PRESCRIBING INFORMATION to inform that the use of and withdrawal from SSRIs and SNRIs can result in genital anesthesia, pleasureless or weak orgasm, delayed or absent orgasm, loss of libido, erectile dysfunction, decreased vaginal lubrication, reduced nipple sensitivity, fl accid glans penis during erection, reduced response to sexual stimuli, and decreased capacity to experience sexual pleasure.2. Add WARNINGS, PRECAUTIONS, and HIGHLIGHTS OF PRESCRIBING INFORMATION to inform that the use of and withdrawal from SSRIs and SNRIs can result in persistent genital arousal disorder (PGAD).3. Add WARNINGS, PRECAUTIONS, HIGHLIGHTS OF PRESCRIBING INFORMATION, and a BOXED WARNING to inform that sexual side effects can sometimes persist for years or indefi nitely after discontinuation of the drug; they can emerge on treatment and remain afterwards, or emerge or worsen when the drug is stopped.4. Send all manufacturers of SSRIs and SNRIs a notifi cation letter of the need for a Risk Evaluation and Mitigation Strategy Plan to include the following: i. Require manufacturers to send a Dear Health Care Provider Letter to psychiatrists, psychologists, internists, family practitioners, urologists and endocrinologists that informs the health care providers that the drug has serious adverse reactions associated with its use, and poses a signifi cant public health concern.
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SSRI-induced sexual dysfunction can include sexual desire, difficulty in arousal, and anorgasmia.
“This disorder can be seen in different fields, including sexual desire, difficulty in arousal, and anorgasmia [20, 21].”
From Effect of l-arginine compared to placebo on sexual function in women with major depressive disorder: a randomized controlled trial (2024) · cites this paper as [20]
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Cites
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Patacchini, A., & Cosci, F. (2020) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000001154 · Cited by 10 · see citing works
Torkaman, P., Meybodi, A. M., Kheradmand, A., Eiliaei, S., & Ardakani, M. T. (2024) · BMC Psychiatry · doi:10.1186/s12888-024-05781-5 · Cited by 1 · see citing works
“This disorder can be seen in different fields, including sexual desire, difficulty in arousal, and anorgasmia [20, 21].”
Background
- Authors
- Healy, D.
- Affiliations
- Data Based Medicine Americas Ltd., 95 Sandringham Drive, Toronto, Ontario, Canada, M3H 1E1.
- Corresponding author
- Healy, David
- Venue
- International Journal of Risk & Safety in Medicine
- Publisher
- SAGE Publications
- Published
- 2018-08
- Volume
- 29
- Issue
- 3-4
- Pages
- 135-147
- ISSN
- 0924-6479 (ISSN-L)
- 1878-6847
- PMC
- PMC6004927
- OpenAlex
- W2799677170
- Cited by
- 32
- References
- 53
- Citations by year
- 2025: 2 · 2024: 8 · 2023: 5 · 2022: 4 · 2021: 3 · 2020: 3 · 2019: 7
- FWCI
- 2.56
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- International Journal of Risk & Safety in Medicine (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Portal (Queen's University Belfast) (publishedVersion, cc-by-nc)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Keywords
- selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, sexual side effects, antidepressant side effects, persistent genital arousal disorder, drug withdrawal, drug labeling, black box warning, risk evaluation and mitigation strategy, prescribing information
- MeSH terms
- Serotonin and Noradrenaline Reuptake Inhibitors, Female, Humans, Libido, Male, Sexual Dysfunction, Physiological
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