Boxed Warning for Serious Mental Health Issues Removed from Chantix and Zyban Labeling

Back in April 2016, we posted a blog regarding the potential for the FDA to remove the Black Box warning on two products indicated to help patients stop smoking based on a large clinical study that the FDA required.  At that time when the studies were submitted, the Agency indicated it would review the results and make a final determination.  Well, on Friday December 16, 2016, two products from two different companies Chantix and Zyban got the news that the FDA concurred with the results of the studies, and the Agency intends to remove the Black Box warning.  See FDA safety announcement here.

While the study result did indicate that there was a slight change in mental health issues (mood, behavior, or thinking) that might occur in patients that already were experiencing such problems before smoking cessation therapy, the risk is very low and that risk is even lower in those patients that did not have such issues prior to beginning the smoking cessation drugs.

Good news for the drug makers and even better news for patients as this may put them at greater ease.  In our previous post (here), we discussed the possibility of lawsuits that may have been initiated against the manufacturers of these product claiming damages for mental health issues occurring from use of these drugs.  We don’t know what (if anything) has happened either in the frequency of such lawsuits or the outcomes since the news broke in April.  We will leave that parsing to the legal experts, but I think we can say for certain that one never knows where these things go.  Remember that about 10 years ago, coffee was not good for you or that margarine was the great health savior over butter.  If I can just live long enough for pizza, sausage sandwiches, ice cream, and 48 ounce steaks to make the top 10 health foods list, I will be a happy man.