On Friday, the Food and Drug Administration removed the “black box” warning about the risk dangerous psychiatric side-effects from Pfizer’s anti-smoking drug, Chantix.
The drug received the bold warning label in 2009 following reports of suicidal tendencies, hostility, and depression in some users.
The FDA decision to remove the warning follows information from a study of 8,000 patients who reported no higher risk of psychiatric problems in Chantix users without prior history of mental illness.
European regulators removed the warning from the drug after similar studies provided the same data.
The American study was funded by Pfizer and GlaxoSmithKline PLC, which markets smoking-cessation drug, Zyban. The FDA also cleared warnings of potential psychiatric effects from Zyban’s label.
Both drugs will still display reports of psychosis, paranoia, anxiety, and similar effects on their packaging. The difference will be that the information will not be emphasized in the warning displayed on the top of the FDA drug label in what is called a “black box warning.”
“The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past,” the FDA stated online.
Irritability, mood swings, and depression are among some of the withdrawal symptoms for those quitting smoking, with or without medication. Smokers are also more likely to experience psychiatric conditions than nonsmokers.
Warnings on Chantix and Zyban about potential “changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions” repelled prospective users and prescribers.
Chantix works by blocking nicotine from binding to spots that are activated by nicotine when people smoke and preventing the release of “feel-good” chemicals in the brain.
