FRIDAY, Nov. 4 (HealthDay News) -- Patients taking varenicline for smoking cessation have a significantly increased risk for reported suicidal/self-injurious behavior or depression, compared to those taking bupropion or nicotine replacement products, according to a study published online Nov. 2 in PLoS One.
Thomas J. Moore, M.D., from the Institute for Safe Medication Practices in Alexandria, Va., and colleagues compared the neuropsychiatric safety profiles of varenicline, bupropion, and nicotine replacement products. Domestic serious case reports for 9,575 varenicline cases, 1,751 bupropion cases, and 1,917 nicotine replacement product cases were selected from the U.S. Food and Drug Administration's adverse event reporting system. The ratio of reported suicide/self-injury or depression for each drug compared to all other serious events for that drug was measured.
The investigators found that, of the 3,249 reported cases of suicidal/self-injurious behavior or depression, 90 percent were for varenicline, 7 percent for bupropion, and 3 percent for nicotine replacement products. Compared to nicotine replacement products, the disproportionality results (odds ratios) of suicidal/self-injurious behavior or depression with varenicline and bupropion were 8.4 and 2.9, respectively. This disproportionality remained even after excluding reports of concomitant therapy with 58 drugs with suicidal behavior warnings or precautions included in the prescribing information. An additional antibiotic comparison group showed that a healthy population receiving short-term drug treatment rarely had adverse event reports of suicidal/self-injurious behavior or depression.
"Varenicline shows a substantial, statistically significant increased risk of reported depression and suicidal/self-injurious behavior," the authors write.
Two authors served as expert witnesses in a U.S. Army General Court Martial for a criminal matter involving varenicline, and as plaintiffs' consulting experts in a U.S. civil litigation relating to varenicline.
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