Monitoring of adverse drug reactions to antidepressant drugs in a teaching hospital

Abstract

Background: Adverse drug reactions (ADRs) are considered among the leading causes of morbidity and mortality. Adverse drug reactions are important determinants of non-adherence to antidepressant treatment, but their assessment is complicated by overlap with depressive symptoms and lack of reliable self-report measures The present study was therefore undertaken to monitor the ADRs of the antidepressant in the psychiatric outpatient unit of Raichur Institute of Medical Sciences, Raichur, Karnataka, IndiaMethods: Study was conducted from December 2012 to November 2013, the patients on antidepressant drugs from psychiatry out- patient department (OPD) of Raichur Institute of Medical Sciences were considered for analysis. The patients were diagnosed by consultant psychiatrist. Data was collected in standard questionnaire format. All patients diagnosed with psychiatric disorder as per ICD 10 criteria and receiving treatment with antidepressant were included. Assessment of causality and severity of recorded adverse events was done using WHO assessment scale and modified Siegel and Hartwig Scale respectively.Results: In our study 74 adverse drug reactions(ADRs) were seen among 52 cases, total 263 cases were screened.CNS and Anticholinergic side effects were most common adverse drug reactions noted. Tricyclic antidepressants (TCA) and Selective serotonin reuptake inhibitors (SSRIs) were the drugs causing maximum ADRs. Assessment of causality and severity of recorded adverse events showed possible to probable and mild to moderate severity respectively.Conclusions: CNS and Anticholinergic side effects were most common adverse drug reactions noted. Tricyclic antidepressants (TCA) were most commonly prescribed drugs followed by Selective serotonin reuptake inhibitors (SSRIs). Tricyclic antidepressants (TCA) and Selective serotonin reuptake inhibitors (SSRIs) accounted for most of ADRs (87.8%). Assessment of causality of recorded adverse events showed no certain cause and assessment of severity of recorded adverse events showed no severe cases.

Assessment of incidence, causality, severity, and preventability of suspected adverse drug reactions to antidepressant medications in a psychiatry outpatient setting of a secondary care hospital

“…[ 4 ] Earlier studies have reported ADR incidence rate varying from 19.8% to 42.39% among patients who took antidepressants. [ 5 6 7 ] Our observation falls within these reported ranges.…”

“…[ 5 ] Another study found that ADRs were mostly observed with TCAs followed by SSRIs. [ 6 ] Somnolence was the second ADR detected in our study. Somnolence was observed with SSRIs and mirtazapine.…”

“…[ 4 ] Another study found that 26.87% of patients who took antidepressants reported ADRs,[ 5 ] whereas another study reported lower rates (19.8%) of ADR. [ 6 ] A prospective observational study reported higher incidence rate of antidepressant ADRs (42.39%) in a tertiary care hospital. [ 7 ] Monitoring and reporting of ADRs can play a vital role in early detection of ADRs and prevent future harm to patients; improve patient safety and improve medicine information and education; and thereby enhance the quality of care, decrease in the cost of the treatment, and better adherence to prescribed medications.…”

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“…A study conducted in Karnataka by Munoli and Patil, which monitored patients prescribed antidepressants for ADRs 16 , reported that 19.8% of all patients developed an adverse drug reaction. The highest incidence of ADRs was seen in imipramine (20.5% developed ADRs), followed by amitriptyline (17%) and sertraline (15%).…”

“…This finding was similar to our study. The common ADRs due to SSRIs encountered in the study conducted in Karnataka 16 included: Forsertralineinsomnia, imbalance, and diarrhea, for fluoxetineinsomnia, anxiety, diarrhea and weight gain and for escitalopram -insomnia and weight gain.…”