The FDA is now requiring the popular smoking-cessation drugs varenicline (Chantix) and bupropion (Zyban) to carry the highest safety warning as reports of suicide and depression among the drugs' users rise.
FDA safety officials said they instituted the mandate after receiving a surprisingly high number of reports of attempted and successful suicide from users—98 suicides and 188 attempted suicides among varenicline users, and 14 suicides and 17 attempted suicides among bupropion users.
The drugs' manufacturers will add new or additional black box warnings to current side effect notices. The companies must also conduct clinical trials to further evaluate the mental health risks associated with the drugs' use.
Officials for both companies said it is difficult to pinpoint the specific impact the smoking-cessation drugs may be having on those risks because symptoms of depression and suicide can occur from nicotine withdrawal as well.
FDA officials stressed they are not advising against the drugs but urged doctors to be aware of the drugs' side effects and monitor patients closely.