ArticleDrug safety2013
Reports of sexual disorders related to serotonin reuptake inhibitors in the French pharmacovigilance database: an example of underreporting.
Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 13 citations in OpenAlex.
- Psychotropic drug-induced adverse drug reactions in 462,661 psychiatric inpatients in relation to age: results from a German drug surveillance program from 1993-2016.Annals of general psychiatry · 2024Article
- Effects of selective serotonin reuptake inhibitors on endocrine system (Review).Biomedical reports · 2024Review
- Sexual Dysfunction Induced by Antidepressants-A Pharmacovigilance Study Using Data from VigiBasePharmaceuticals (Basel, Switzerland) · 2024Article
- Reasons for Discontinuation or Change of Selective Serotonin Reuptake Inhibitors in Online Drug Reviews.JAMA network open · 2023Article
- Patient reporting of sexual adverse events on an online platform for medication experiences.British journal of clinical pharmacology · 2022Article
- Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database.Drug safety · 2022Article
- Which adverse effects influence the dropout rate in selective serotonin reuptake inhibitor (SSRI) treatment? Results for 50,824 patients.German medical science : GMS e-journal · 2014Article
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDepressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs).
objectiveThe aim of this study was to determine the reporting rate of sexual disorders in association with SRIs, and to investigate the association between reported cases and the use of SRIs.
methodsAll cases of adverse drug reactions (ADRs) involving sexual disorders, spontaneously reported to the French Pharmacovigilance Database from 1 January 1985 to December 2009, were reviewed. Cases of sexual disorders in SRI users were described. We calculated the rate of reported sexual disorders as a percentage of the total ADRs reported for each drug. The association between reported cases and the use of SRIs was assessed using reporting odds ratios (ROR) with 95 % confidence intervals (CIs).
resultsA total of 11,863 ADRs in association with SRIs were collected, of which 98 (0.83 %) were spontaneous reports of sexual disorders. Subjects were, on average, 45.0 ± 10.6 years of age and mainly male. Sexual disorders were associated with the use of SRI antidepressants (ROR 4.47; 95 % CI 3.61-5.53), milnacipran (ROR 11.72; 95 % CI 5.79-23.72), fluvoxamine (ROR 6.91; 95 % CI 3.79-12.58), paroxetine (ROR 5.54; 95 % CI 3.92-7.83), venlafaxine (ROR 3.50; 95 % CI 1.93-6.36), fluoxetine (ROR 3.46; 95 % CI 2.26-5.29), citalopram (ROR 2.69; 95 % CI 1.28-5.67) and sertraline (ROR 2.49; 95 % CI 1.03-6.01).
conclusionIt is likely that there are instances of underreporting, particularly for ADRs that are embarrassing to talk about spontaneously. Despite the likely underreporting of this well-described adverse effect, this case/non-case study performed in a large national pharmacovigilance database confirms the existence of the risk of sexual disorders associated with SRIs, and is an example of the lack of sensitivity of spontaneous notification to measure ADRs. Minimization of antidepressant-induced sexual dysfunction could be an important factor to avoid unsuccessful treatment. Physicians should advise their patients on the possible sexual adverse effects.
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