Adverse Drug Events on the Use of Sertraline in Clinical Studies: A Review

https://doi.org/10.22146/jmpf.56558

Syahrul Hidayat(1*), Irma M. Puspitasari(2)

(1) Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Padjajaran University
(2) Center of Excellence in Science and Technology for Pharmaceutical Service Innovation, Padjajaran University
(*) Corresponding Author

Abstract


Major depressive disorder (MDD) and anxiety are known as a widespread public health problem treated with sertraline, a class of Selective Serotonin Reuptake Inhibitor (SSRI) drugs as first-line therapy. However, clinical evidence showed that MDD and anxiety therapy with sertraline has not been optimal due to patient non-compliance associated with adverse drug events (ADE) occurring. A literature search on sertraline clinical study was conducted on the PubMed and Science Direct electronic database in April 2020. A total of 12 articles from 5.664 articles have been selected at the initial screening. A total of 6 articles used sertraline as a testing drug in MDD patients, 2 articles used sertraline as testing drug in anxiety patients, 2 articles with sertraline as a comparative drug, 1 article with sertraline as a positive control, and 1 article with sertraline as an adjuvant in MDD patients. Studies on these articles were carried out worldwide from 2010 to 2019. ADEs that occur due to the use of sertraline were: gastrointestinal disorders, nutritional and metabolic disorders, central nervous system disorders, sweating, sleep disorders, irritability, eye disorders, as well as disorders of the skin and subcutaneous tissues. Nausea is the most common ADE of sertraline. ADEs are affected by several factors such as, age, the sertraline combination therapy, and alcohol consumption.


Keywords


Adverse Drug Event; Major Depressive Disorder; Sertraline; SSRI

Full Text:

PDF


References

  1. Kessler RC. The cost of depression. Psychiatr Clin North Am. 2012;35(1): 1-14.
  2. WHO. Depression and Other Common Mental Disorders. Geneva: WHO; 2017: 1-21.
  3. Stewart AD, Dachs R, Graber MA. Antidepressants for initial treatment of depression. Am Fam Physician. 2010;81(10): 1205-1212.
  4. Strawn JR, Geracioti L, Rajdev N, Clemenza K, Levine A. Pharmacotherapy for generalized anxiety disorder in adult and pediatric patients: an evidence-based treatment review. Expert Opin Pharmacother. 2018;19(10): 1057-1070.
  5. Zoloft (Sertraline hydrochloride) Label. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf. Updated 2016. Accessed May 1st, 2020.
  6. Castro-Rodríguez JI, Olariu E, Garnier-Lacueva C, et al. Diagnostic accuracy and adequacy of treatment of depressive and anxiety disorders: A comparison of primary care and specialized care patients. J Affect Disord. 2015;172: 462-471.
  7. Duhoux A, Fournier L, Gauvin L, Roberge P. What is the association between quality of treatment for depression and patient outcomes? A cohort study of adults consulting in primary care. J Affect Disord. 2013;151(1): 265-274.
  8. Yau WY, Chan MC, Wing YK, et al. Noncontinuous use of antidepressant in adults with major depressive disorders - a retrospective cohort study. Brain Behav. 2014;4: 390-397.
  9. Hung CI. Factors predicting adherence to antidepressant treatment. Curr Opin Psychiatry. 2014;27(5): 344-349.
  10. Fortney JC, Pyne JM, Edlund MJ, et al. Reasons for antidepressant nonadherence among veterans treated in primary care clinics. J Clin Psychiatry. 2011;72: 827-834.
  11. Bull SA, Hunkeler EM, Lee JY, et al. Discontinuing or switching selective serotonin-reuptake inhibitors. Ann Pharmacother. 2002;36: 578-584.
  12. Adverse Drug Events. U.S. Department of Health and Human Services. https://health.gov/our-work/health-care-quality/adverse-drug-events#ref1. Updated 2020. Accessed May 1st, 2020.
  13. Ayani N, Sakuma M, Morimoto T, et al. The epidemiology of adverse drug events and medication errors among psychiatric inpatients in Japan: the JADE study. BMC Psychiatry. 2016;16(1): 303.
  14. Oslin DW, Kampman KM, Dundon WD, et al. A Double-Blind, Placebo-Controlled Trial Combining Sertraline and Naltrexone for Treating Co-Occurring Depression and Alcohol Dependence. Am J Psychiatry. 2010;167: 668-675.
  15. Katz AJ, Dusetzina SB, Farley JF, et al. Distressing adverse events after antidepressant switch in the sequenced treatment alternatives to relieve depression (STAR*D) trial: Influence of adverse events during initial treatment with citalopram on development of subsequent adverse events with an alternative antidepressant. Pharmacotherapy. 2012;32(3): 234-243.
  16. Blumberger DM, Mulsant BH, Kanellopoulos D, et al. The incidence of tardive dyskinesia in the study of pharmacotherapy for psychotic depression. J Clin Psychopharmacol. 2013;33(3): 391-397.
  17. Chen JA, Vijapura S, Papakostas GI, et al. Association between physician beliefs regarding assigned treatment and clinical response: Re-analysis of data from the Hypericum Depression Trial Study Group. Asian J Psychiatr. 2015;13: 23-29.
  18. Cvjetkovic-Bosnjak M, Soldatovic-Stajic B, Babovic SS, Boskovic K, Jovicevic M. Pregabalin versus sertraline in generalized anxiety disorder. An open label study. Eur Rev Med Pharmacol Sci. 2015;19(11): 2120-2124.
  19. Reid AM, McNamara JPH, Murphy TK, et al. Side-effects of SSRIs disrupt multimodal treatment for pediatric OCD in a randomized-controlled trial. J Psychiatr Res. 2015;71: 140-147.
  20. Amidfar M, Khiabany M, Kohi A, et al. Effect of memantine combination therapy on symptoms in patients with moderate-to-severe depressive disorder: randomized, double-blind, placebo-controlled study. J Clin Pharm Ther. 2017;42(1): 44-50.
  21. Li W, Ma YB, Yang Q, Li BL, Meng QG, Zhang Y. Effect and safety of sertraline for treat posttraumatic stress disorder: a multicenter randomised controlled study. Int J Psychiatry Clin Pract. 2017;21(2): 151-155.
  22. Liu W, Qin J. Clinical efficacy and safety of the Shugan Jieyu capsule in patients with acute myocardial infarction and depression. Int J Psychiatry Med. 2016;51(6): 534-543.
  23. Kamijima K, Kimura M, Kuwahara K, Kitayama Y. A randomized, double-blind comparison of aripiprazole/sertraline combination and placebo/sertraline combination in patients with major depressive disorder. Psychiatry Clin Neurosci. 2018;72(8): 591-601.
  24. Papakostas GI, Nielsen RZ, Dragheim M, Tonnoir B. Efficacy and tolerability of vortioxetine versus agomelatine, categorized by previous treatment, in patients with major depressive disorder switched after an inadequate response. J Psychiatric Res. 2018;101: 72-79.
  25. Popova V, Daly EJ, Trivedi M, et al. Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in treatment-resistant depression: A randomized double-blind active-controlled study. Am J Psychiatr. 2019;176(6): 428-438.
  26. Gershon MD. 5-Hydroxytryptamine (serotonin) in the gastrointestinal tract. Curr Opin Endocrinol Diabetes Obes. 2013;20(1): 14-21.
  27. Janssen P, Vos R, Tack J. The influence of citalopram on interdigestive gastrointestinal motility in man. Aliment Pharmacol Ther. 2010;32(2): 289-295.
  28. Browning KN. Role of central vagal 5-HT3 receptors in gastrointestinal physiology and pathophysiology. Front Neurosci. 2015;9: 413.
  29. Watson LR, Foley M, Hurd R. When Your Weight Gain Is Caused by Medicine. https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=56&contentid=DM300. Updated 2020. Accessed May 1st, 2020.
  30. Zimmermann U, Kraus T, Himmerich H, et al. Epidemiology, implications and mechanisms underlying drug-induced weight gain in psychiatric patients. J Psychiatr Res. 2003;37: 193-220.
  31. Madhusoodanan S, Alexeenko L, Sanders R, Brenner R. Extrapyramidal symptoms associated with antidepressants--a review of the literature and an analysis of spontaneous reports. Ann Clin Psychiatry. 2010;22(3): 148-156.
  32. Carvalho A, F, Sharma M, S, Brunoni A, R, et al. The safety, tolerability and risks associated with the use of newer generation antidepressant drugs: a critical review of the literature. Psychother Psychosom. 2016;85: 270-288.
  33. Bortolato B, Carvalho AF, McIntyre RS. Cognitive dysfunction in major depressive disorder: a state-of-the-art clinical review. CNS Neurol Disord Drug Targets. 2014;13(10): 1804-1818.
  34. What Is Dissociation. WebMD. https://www.webmd.com/mental-health/dissociation-overview#1. Updated 2020. Accessed May 1st, 2020.
  35. Costa RM. Dissociation (Defense Mechanism). In: Zeigler-Hill V, Shackelford TK, eds. Encyclopedia of Personality and Individual Differences. Cham: Springer International Publishing. 2016: 1-3.
  36. Kolli V, Ramaswamy S. Improvement of antidepressant-induced sweating with as-required benztropine. Innov Clin Neurosci. 2013;10(11-12):10-11.
  37. Wichniak A, Wierzbicka A, Walęcka M, Jernajczyk W. Effects of Antidepressants on Sleep. Curr Psychiatry Rep. 2017;19(9): 63.
  38. Doghramji K, Jangro WC. Adverse effects of psychotropic medications on sleep. Psychiatr Clin North Am. 2016;39: 487–502.
  39. Zoloft. Medsafe. https://medsafe.govt.nz/profs/Datasheet/z/Zolofttab.pdf. Updated 2019. Accessed May 1st, 2020.
  40. Chen HY, Lin CL, Lai SW, Kao CH. Association of selective serotonin reuptake inhibitor use and acute angle-closure glaucoma. J Clin Psychiatry. 2016; 77(6): e692-e696.
  41. Bliss SA, Warnock JK. Psychiatric medications: adverse cutaneous drug reactions. Clin Dermatol. 2013;31(1): 101-109.
  42. Alomar MJ. Factors affecting the development of adverse drug reactions (Review article). Saudi Pharm J. 2014;22(2): 83-94.



DOI: https://doi.org/10.22146/jmpf.56558

Article Metrics

Abstract views : 4188 | views : 3001

Refbacks

  • There are currently no refbacks.


Copyright (c) 2021 JURNAL MANAJEMEN DAN PELAYANAN FARMASI (Journal of Management and Pharmacy Practice)

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

©Jurnal Manajemen dan Pelayanan Farmasi
Faculty of Pharmacy
Universitas Gadjah Mada
Creative Commons License
View My Stats