nach oben

Drug Safety

Erschienen in:

01.07.2018 | short communication

Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors

verfasst von: Corine Ekhart, Florence van Hunsel, Joep Scholl, Sieta de Vries, Eugene van Puijenbroek

Erschienen in: Drug Safety | Ausgabe 7/2018

Einloggen, um Zugang zu erhalten

Abstract

Introduction

Several studies have investigated sex as a risk factor for the occurrence of adverse drug reactions (ADRs) and found that women are more likely to experience ADRs than men.

Objective

The aim of this explorative study was to investigate whether differences exist in reported ADRs of selective serotonin reuptake inhibitors (SSRIs) for men and women in the database of the Netherlands Pharmacovigilance Centre Lareb.

Methods

A ratio of reports concerning women and men, corrected for the number of users, was calculated for all the ADRs reported on SSRIs.

Results

We found that 16 ADRs were statistically significantly more reported in women than men, and four ADRS were reported more in men than women.

Conclusion

ADRs more reported in women than men when using SSRIs were usually dose-related ADRs or commonly occurring ADRs. Differences in the pharmacokinetics of SSRIs between men and women may explain why these reports of dose-related ADRs when using SSRIs concern women more than men.

Franconi F, Brunelleschi S, Steardo L, Cuomo V. Gender differences in drug responses. Pharmacol Res. 2007;55:81–95.CrossRefPubMed

Zopf Y, Rabe C, Neubert A, Gassmann KG, Rascher W, Hahn EG, et al. Women encounter ADRs more often than do men. Eur J Clin Pharmacol. 2008;64:999–1004.CrossRefPubMed

Fattinger K, Roos M, Vergeres P, Holenstein C, Kind B, Masche U, et al. Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine. Br J Clin Pharmacol. 2000;49:158–67.CrossRefPubMedPubMedCentral

Martin RM, Biswas PN, Freemantle SN, Pearce GL, Mann RD. Age and sex distribution of suspected adverse drug reactions to newly marketed drugs in general practice in England: analysis of 48 cohort studies. Br J Clin Pharmacol. 1998;46:505–11.CrossRefPubMedPubMedCentral

Rodenburg EM, Stricker BH, Visser LE. Sex-related differences in hospital admissions attributed to adverse drug reactions in the Netherlands. Br J Clin Pharmacol. 2011;71:95–104.CrossRefPubMedPubMedCentral

Drici MD, Clement N. Is gender a risk factor for adverse drug reactions? The example of drug-induced long QT syndrome. Drug Saf. 2001;24:575–85.CrossRefPubMed

Warnock JK, Morris DW. Adverse cutaneous reactions to antidepressants. Am J Clin Dermatol. 2002;3:329–39.CrossRefPubMed

Vilhelmsson A, Svensson T, Meeuwisse A, Carlsten A. What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association. BMC Clin Pharmacol. 2011;11:16.CrossRefPubMedPubMedCentral

D’Incau P, Lapeyre-Mestre M, Carvajal A, Donati M, Salado I, Rodriguez L, et al. No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from France, Italy and Spain. Fundam Clin Pharmacol. 2014;28:342–8.CrossRefPubMed

10.

Kostev K, Rex J, Eith T, Heilmaier C. Which adverse effects influence the dropout rate in selective serotonin reuptake inhibitor (SSRI) treatment? Results for 50,824 patients. Ger Med Sci. 2014;12:Doc15.PubMedPubMedCentral

11.

Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20:109–17.CrossRefPubMed

12.

ATC/DDD Index 2018. https://www.whocc.no/atc_ddd_index/. Accessed 30 Jan 2018.

13.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–45.CrossRefPubMed

14.

Debonnel G, Saint-Andre E, Hebert C, de Montigny C, Lavoie N, Blier P. Differential physiological effects of a low dose and high doses of venlafaxine in major depression. Int J Neuropsychopharmacol. 2007;10:51–61.CrossRefPubMed

15.

GIPdatabase - drug information system of the Dutch Health Care Insurance Board. http://www.gipdatabank.nl. Accessed 8 Feb 2017.

16.

Preskorn SH. Clinically relevant pharmacology of selective serotonin reuptake inhibitors. An overview with emphasis on pharmacokinetics and effects on oxidative drug metabolism. Clin Pharmacokinet. 1997;32(Suppl 1):1–21.CrossRefPubMed

17.

Meyboom RH, Lindquist M, Egberts AC. An ABC of drug-related problems. Drug Saf. 2000;22:415–23.CrossRefPubMed

18.

Bigos KL, Pollock BG, Stankevich BA, Bies RR. Sex differences in the pharmacokinetics and pharmacodynamics of antidepressants: an updated review. Gend Med. 2009;6:522–43.CrossRefPubMed

19.

Reis M, Lundmark J, Bengtsson F. Therapeutic drug monitoring of racemic citalopram: a 5-year experience in Sweden, 1992–1997. Ther Drug Monit. 2003;25:183–91.CrossRefPubMed

20.

Reis M, Olsson G, Carlsson B, Lundmark J, Dahl ML, Walinder J, et al. Serum levels of citalopram and its main metabolites in adolescent patients treated in a naturalistic clinical setting. J Clin Psychopharmacol. 2002;22:406–13.CrossRefPubMed

21.

Ronfeld RA, Tremaine LM, Wilner KD. Pharmacokinetics of sertraline and its N-demethyl metabolite in elderly and young male and female volunteers. Clin Pharmacokinet. 1997;32(Suppl 1):22–30.CrossRefPubMed

22.

Ferguson JM, Hill H. Pharmacokinetics of fluoxetine in elderly men and women. Gerontology. 2006;52:45–50.CrossRefPubMed

23.

Gex-Fabry M, Eap CB, Oneda B, Gervasoni N, Aubry JM, Bondolfi G, et al. CYP2D6 and ABCB1 genetic variability: influence on paroxetine plasma level and therapeutic response. Ther Drug Monit. 2008;30:474–82.PubMed

24.

Geneesmiddeleninformatiebank. Summary of product characteristics. http://www.geneesmiddeleninformatiebank.nl. Accessed 8 Feb 2017.

25.

Jakubovski E, Varigonda AL, Freemantle N, Taylor MJ, Bloch MH. Systematic review and meta-analysis: dose-response relationship of selective serotonin reuptake inhibitors in major depressive disorder. Am J Psychiatry. 2016;173:174–83.CrossRefPubMed

26.

Bech P, Tanghoj P, Andersen HF, Overo K. Citalopram dose-response revisited using an alternative psychometric approach to evaluate clinical effects of four fixed citalopram doses compared to placebo in patients with major depression. Psychopharmacology (Berl). 2002;163:20–5.CrossRef

27.

Rouve N, Bagheri H, Telmon N, Pathak A, Franchitto N, Schmitt L, et al. Prescribed drugs and violence: a case/noncase study in the French PharmacoVigilance Database. Eur J Clin Pharmacol. 2011;67:1189–98.CrossRefPubMed

28.

Molero Y, Lichtenstein P, Zetterqvist J, Gumpert CH, Fazel S. Selective serotonin reuptake inhibitors and violent crime: a cohort study. PLoS Med. 2015;12:e1001875.CrossRefPubMedPubMedCentral

29.

Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf. 2012;35:807–18.CrossRefPubMed

30.

Miller MA. Gender-based differences in the toxicity of pharmaceuticals—the Food and Drug Administration’s perspective. Int J Toxicol. 2001;20:149–52.CrossRefPubMed

Titel: Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors
verfasst von: Corine Ekhart
Florence van Hunsel
Joep Scholl
Sieta de Vries
Eugene van Puijenbroek
Publikationsdatum: 01.07.2018
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 7/2018
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-018-0646-2

Springer Medizin

Abstract

Introduction

Objective

Methods

Results

Conclusion

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 7/2018

Interest in a Mobile App for Two-Way Risk Communication: A Survey Study Among European Healthcare Professionals and Patients

Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants

Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring

Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study

Thromboembolism with Janus Kinase (JAK) Inhibitors for Rheumatoid Arthritis: How Real is the Risk?

Glucocorticoids and the Risk of Peptic Ulcer Bleeding: Case–Control Analysis Based on Swiss Claims Data