Drug‑Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database. 2022

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anacleta
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Drug‑Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database. 2022

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Drug Saf. 2022 Apr 7. doi: 10.1007/s40264-022-01174-3.

Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database

Carolina Valeiro, Cristiano Matos, Joep Scholl, Florence van Hunsel

PMID: 35386045 DOI: 10.1007/s40264-022-01174-3

Abstract

Introduction: Sexual dysfunction (SD) is a problem that can affect any phase of the sexual response cycle (such as sexual desire, arousal and orgasm) and individuals of any age. SD can be caused by physical reasons, such as medical conditions, alcoholism or drug abuse; psychological factors, such as stress and anxiety; and different medicines, such as selective serotonin reuptake inhibitors (SSRIs), and their associated adverse effects.

Aim: The aim of this study was to characterise drugs suspected to have caused SD adverse drug reactions (ADRs) in patients, by conducting a descriptive study based on pharmacovigilance reports.

Methods: Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2019 were used to investigate drug-induced sexual disorders. Selected reports had at least one ADR reported in the Medical Dictionary for Regulatory Activities (MedDRA®) System Organ Class (SOC) 'Reproductive system and breast disorders' and the SOC 'Psychiatric disorders' relating to sexual disorders and corrected for drug utilisation (expenditure) for the Dutch population.

Results: A total of 2815 SD ADRs were reported in the observed period. Data were divided according to three variables: pharmacotherapeutic group, the drug itself, and sex. A total of 722 different SD/pharmacotherapeutic group pairs were observed. The pharmacotherapeutic groups with the highest frequency of SD reports were SSRIs (n = 488, 17.58%), other antidepressants (n = 172, 6.20%) and HMG-CoA reductase inhibitors (n = 149, 5.37%). Distinguishing ADRs by sex, men suffered more from erectile dysfunction, decreased libido and ejaculation disorders, while among women, libido disorders, dyspareunia and SD were the most common ADRs.

Conclusion: Different reactions and disproportionality of reactions were detected between the sexes. Antidepressants, antihypertensives, oral contraceptives, α-blockers, and anti-androgens were the pharmacotherapeutic groups with the highest number of SD reports and corresponding high odds ratios.

https://pubmed.ncbi.nlm.nih.gov/35386045/



From the full text, on SSRIs and PSSD:

There are reports of patients who stopped using SSRIs who did not regain normal sexual functioning, with symptoms persisting up to 2 years [39].
39. Healy D. Citizen petition: sexual side efects of SSRIs and SNRIs. Int J risk Saf Med. 2018;29(3–4):135.

The pharmacotherapeutic groups with the highest frequency of reports on SD were SSRIs (n = 488, 17.58%), antidepressants (n = 172, 6.20%) and HMG-CoA reductase inhibitors (n = 149, 5.37%), followed by α-adrenoreceptor antagonists (n = 141, 5.01%) and intrauterine contraceptives (n = 108, 3.84%).

Diferences in underreporting of SD could be infuenced by factors such as sex or disease. For instance, among patients with SD in association with SSRI therapy, there was strong ADR underreporting, particularly among women [56].
56. Trenque T, Maura G, Herlem E, Vallet C, Sole E, Auriche P, et al. Reports of sexual disorders related to serotonin reuptake inhibitors in the French pharmacovigilance database: an example of underreporting. Drug Saf. 2013;36(7):515–9

The sexual adverse efects of SSRIs are attributed to their mechanism of action, due to the increasing availability of serotonin, which may afect other hormones and
eurotransmitters, such as testosterone and dopamine, leading to adverse efects of SD, as testosterone may afect sexual arousal and dopamine plays a role in achieving orgasm [59–61].

Another area that deserves more in-depth study is the burden and consequences of (prolonged) drug-induced SD. Lareb has recently published a scoping review and presentation of 86 cases on persistent SD after SSRI withdrawal (PSSD) [76]. PSSD impact includes sexual, psychological, and social consequences and is not always recognised by healthcare professionals. We have not yet explored the impact of drug-induced SD for other types of drugs and how to manage these ADRs.

SSRIs, antidepressants, and HMG-CoA reductase inhibitors are more likely to cause SD as an ADR. Men sufered more from ED, decreased libido and ejaculation disorders, while women experienced decreased libido, dyspareunia and anorgasmia. Citalopram had a higher rate of a loss of libido in males but a higher OR for causing SD in women. More men than women reported decreased libido with fuoxetine and paroxetine.
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anacleta
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Re: Drug‑Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database. 2022

Unread post by anacleta »

I know that a guy from the UK had asked for information on the reports received from the UK pharmacovigilance agency and had been granted: https://www.gov.uk/government/publicati ... foi-21-232

I have not had the same success with AIFA, I contacted what seemed to me to be the only service offered to request information, but I was told that they do not deal with suspected adverse reactions... I don't know.
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