Adverse events during antidepressant treatment : prescription event monitoring studies with mirtazapine and paroxetine in general medical practice in England

Biswas, Pipasha Nandy (2005) Adverse events during antidepressant treatment : prescription event monitoring studies with mirtazapine and paroxetine in general medical practice in England. University of Southampton, Doctoral Thesis.

Record type: Thesis (Doctoral)

Abstract

The research described within this thesis aimed to evaluate the profile of adverse events during treatment with the antidepressant mirtazapine in general medical practice in England. The method employed was Prescription Event Monitoring (PEM), which is non-interventional, and provides ‘real world’ clinical data: patients included within this method are considered more representative of the wider population exposed to the drug, than patient samples included within clinical trial databases.

Using the Drug Safety Research Unit PEM database, events reported during treatment with mirtazapine were analysed and compared with events reported with the selective serotonin reuptake inhibitor paroxetine. Incidence densities (IDs) for reported events were calculated, during the first month of treatment (ID₁) and during months two to six (ID₂) for mirtazapine and paroxetine, The profile of reported adverse events was compared to the description within the Summary of Product Characteristics (SPC) for mirtazapine and previously unrecognised events are described.

The most frequently reported suspected adverse drug reactions (ADRs) were ‘unspecified’ side effects (n=177), drowsiness/sedation (116) and malaise/lassitude (71). Events with highest incidence density in the first month (ID₁ per 1000 patient-months treatment) were: drowsiness/sedation (58.1), malaise/lassitude (27.8) and dizziness (15.6). The most frequently reported events for stopping mirtazapine were: not effective (2432), drowsiness/sedation (800) and weight gain (362). Adverse events possibly due to mirtazapine but not included within the SPC were agitation (73), aggression (70), dizziness (122), rash (20), hallucinations (13), abnormal dreams (31), oedema (30), palpitations (10) and tremor (14).

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