
The Food and Drug Administration warns that patients taking the popular stop-smoking drugs Chantix and Zyban should be watched closely for signs of serious mental illness.
The warning was issued following mounting reports of bizarre behavior, including suicide, among users of the drugs. Pfizer is the maker of Chantix and GlaxoSmithKine is the manufacturer of Zyban.
Both of the drugs will now be required to carry “black box” labels warning that people who take the drugs should be closely monitored for signs of suicidal thoughts, depression, hostility, and other behavioral changes.
a total of 98 suicides and 188 attempted suicides have been seen in user of Chantix as well as 14 suicides and 17 attempted suicides in Zyban users, according to data from the FDA’s adverse event reporting system.
Analysts do not foresee the FDA action having much effect on future sales because of the previous indications of psychiatric risks linked to use of Chantix.
The purpose of the new boxed warning is to raise particular issue of concern to physicians so they can mitigate it, by being more vigilant and monitor patients more actively.
It is not clear why the drugs are associated with mental problems. Although some patients may be experiencing nicotine withdrawal, some adverse affects involved patients who had yet to stop smoking.