The study found no clear evidence that varenicline was associated with an increased risk of fatal or non-fatal self-harm.
Article date: October 2009
A study has recently been published which used the General Practice Research Database to determine whether varenicline▼ may be associated with an increased risk of suicide and suicidal behaviour compared with bupropion or nicotine-replacement therapy (NRT). This nested cohort study analysed 80 660 people prescribed a new course of smoking-cessation product between Sept 1, 2006 and May 31, 2008.
See Gunnell D, et al. BMJ 2009; 339: b3805.
The study found no clear evidence that varenicline was associated with an increased risk of fatal or non-fatal self-harm, although a two-fold increased risk cannot be ruled out on the basis of the upper 95% CI. Compared with NRT, the hazard ratio for self-harm in people prescribed varenicline was 1·12 (95% CI 0·67–1·88), and was 1·17 (0·59–2·32) for those prescribed bupropion. There was no evidence that varenicline was associated with increased risk of depression (0·88 [0·77–1·00]) or suicidal thoughts (1·43 [0·53–3·85]).
As with all medicines, the MHRA will continue to closely monitor the safety of varenicline. Please remember that you can report any suspected adverse reactions to varenicline on a Yellow Card at www.yellowcard.gov.uk
Article citation: Drug Safety Update Oct 2009, vol 3 issue 3: 11.