Table of Contents  
Year : 2013  |  Volume : 6  |  Issue : 4  |  Page : 488-489  

Pharmacovigilance of serotonin reuptake inhibitors

Department of Psychiatry, Mahatma Gandhi Missions Medical College, Kamothe, Navi Mumbai, Maharashtra, India

Date of Web Publication17-Sep-2013

Correspondence Address:
Darpan Kaur
8/187, M.H.B., Om-Lamba Society, Opposite Bhakti-Dham Mandir, Sion-Chunabhatti, Mumbai, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0975-2870.118302

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How to cite this article:
Kaur D, Ajinkya S. Pharmacovigilance of serotonin reuptake inhibitors. Med J DY Patil Univ 2013;6:488-9

How to cite this URL:
Kaur D, Ajinkya S. Pharmacovigilance of serotonin reuptake inhibitors. Med J DY Patil Univ [serial online] 2013 [cited 2024 Feb 24];6:488-9. Available from:


Pharmacovigilance is described as the science relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. It has evolved into a science that is critical to effective clinical practice and public health. Patient care and safety in relation to the use of medicines are of paramount importance in pharmacovigilance. [1]

Montastruc et al. conducted a study to quantify the importance of drug-drug interactions (DDIs) in the occurrence of adverse drug reactions (ADRs) reported with serotoninergic reuptake inhibitors (SSRIs) in a pharmacovigilance database. They found that the most frequent antidepressant involved in DDIs was escitalopram, followed by fluoxetine and citalopram. Among the 65 ADRs related to DDIs, 37 (52.9%) were "serious", mainly bleedings, confusion, falls, hyponatremia and serotoninergic syndromes. The most frequent drug interactions occurred with psychotropics, antithrombotic agents, diuretics and angiotensin II antagonists. [2]

Bleeding has been a major concern with selective serotonin reuptake inhibitors (SSRIs), since their introduction. Evidence supports a moderately increased risk of bleeding associated with the use of SSRIs. This may be dependent on patient susceptibility and presence of risk factors. The impairment of primary hemostasis induced by SSRIs may result in reduction of thrombotic risk. The risk of gastrointestinal bleeding appears to increase with age. The addition of an acid-suppressing agent to the SSRI drug regimen in elderly patients with a previous history of upper-gastrointestinal bleeding, peptic ulcer, and concomitant usage of NSAIDs, oral anticoagulants, antiplatelet drugs and corticosteroids is indicated. [3]

There are existing reports of cases of increased suicidality with SSRIs. Literature reviewed suggests that the results of clinical studies investigating risk of suicide with SSRIs are inconclusive, with some supporting a link and others refuting one. Depression is associated with an inherent risk of suicide. Lapierre YD comments that there is not adequate evidence to claim that usage of SSRIs can directly lead to suicide. [4]

Jimenez-Solem E et al. investigated the role of exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations. Their study design comprised of a register-based retrospective nationwide cohort study and the participants were pregnant women in Denmark between 1997 and 2009 and their offspring. They found an association between exposure to an SSRI during the first trimester and major congenital malformations of the cardiac and digestive systems. They reported that ventricular septal defects and atrial septal defects were specific cardiac anomalies associated with exposure to SSRIs. They also found an association between women with paused SSRI exposure during pregnancy and congenital malformations of the heart. They concluded that the apparent association between SSRI use and congenital malformations of the heart may be confounded by indications. They suggested that the risk versus benefit model should be applied in individual case scenarios for use of SSRIs during pregnancy. [5]

We believe that pharmacovigilance facilitates the safe and rational use of medications, thereby improving the existing standards in modern medicine. Further studies in the arena of pharmacovigilance regarding psychiatric medications from developing countries are needed.

  References Top

1.A short history of involvement in drug safety monitoring. The importance of pharmacovigilance safety monitoring of medicinal products. Geneva: World Health Organization; 2002.  Back to cited text no. 1
2.Montastruc F, Sommet A, Bondon-Guitton E, Durrieu G, Bui E, Bagheri H, et al. The importance of drug-drug interactions as a cause of adverse drug reactions: A pharmacovigilance study of serotoninergic reuptake inhibitors in France. Eur J Clin Pharmacol 2012;68:767-75.  Back to cited text no. 2
[PUBMED] Abajo FJ. Effects of selective serotonin reuptake inhibitors on platelet function: Mechanisms, clinical outcomes and implications for use in elderly patients. Drugs Aging 2011;28:345-67.  Back to cited text no. 3
4.Lapierre YD. Suicidality with selective serotonin reuptake inhibitors: Valid claim? J Psychiatry Neurosci 2003;28:340-7.  Back to cited text no. 4
5.Jimenez-Solem E, Andersen JT, Petersen M, Broedbaek K, Jensen JK, Afzal S, et al. Exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations: A nationwide cohort study. BMJ Open 2012;2:e001148  Back to cited text no. 5


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