Psychiatric events reported in the varenicline prescription-event monitoring study
Rachna Kasliwal, Clinical Research Fellow, Drug Safety Research Unit, Southampton, UK
Regulatory concerns have arisen about psychiatric events with varenicline including, changes in mood/behaviour, worsening of psychiatric illness and suicidal behaviour. A post-marketing study is being conducted, using the observational cohort technique of Modified Prescription-Event Monitoring, to monitor the safety profile of varenicline, prescribed in general practice.
Interim cohort: 2682 patients, median age 47 years;
60.7% females (1627).
The most frequent psychiatric events (causality not implied) reported ‘on’ varenicline were: ‘sleep disorder’ (1.7%; 45/2682), anxiety, depression (both 1.0%; 28/2682). 15 of 28 patients with depression and 17 of 28 patients with anxiety, did not have a previous history of psychiatric illness. The most frequent psychiatric reason for discontinuing varenicline was ‘sleep disorders’ (n=17; 6.7% of clinical reason for discontinuing varenicline).
Two cases of attempted suicide were reported during treatment with varenicline (both patients had previous history of psychiatric illness). In 1st month after stopping varenicline 2 cases of suicidal ideation were reported, including one in the patient who attempted suicide whilst taking varenicline (one patient had previous history of psychiatric illness but the other did not).
Further evaluation of psychiatric events to assess causality is ongoing. The results presented are expected to change as the cohort size increases.
About the presenter
Rachna Kasliwal has a medical background and a Masters degree in Public Health. She has been working as a Clinical Research Fellow at the Drug Safety Research Unit (DSRU) since 2004, involved in conducting studies to monitor the safety profile of newly marketed drugs.