The results are in, and they're not as daunting as expected. When the Food and Drug Administration (FDA) first expressed concerns about possible increased risk of cardiovascular adverse events associated with the smoking-cessation drug Chantix (varenicline) in a Drug Safety Communication (DSC) in June 2011, one of the steps the agency said it would take would be to require Pfizer, the drug’s manufacturer, to conduct a meta-analysis of controlled trials of the drug. The FDA has now presented the results of that meta-analysis, which showed a higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) in patients using Chantix compared with those on placebo. These events, however, were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or to chance.The FDA advised health care professionals to weigh the risks of Chantix against its benefits, while noting that smoking is a major risk factor for cardiovascular disease, and Chantix is effective in helping patients quit smoking and abstain from it for as long as one year. “The health benefits of quitting smoking are immediate and substantial,” the agency emphasized in the communication. The Warnings and Precautions section of the Chantix label has been updated to include the results of the meta-analysis.The DSC is posted at www.fda.gov/Drugs/DrugSafety/ucm330367.htm.Data have also suggested that varenicline may be an effective treatment for patients with schizophrenia. Read more about that topic in Psychiatric News here. And for a study of genetic risk and smoking-cessation treatment, see the American Journal of Psychiatry here. (Image: Goodluz/Shutterstock.com)
