Popular smoking cessation drugs Chantix and Zyban received black box warnings from the FDA, the strongest of its kind.
Chantix, in particular, is quite effective in helping patients to quit smoking, but has been dogged by instances of increased suicidality, especially in those already having a psychiatric diagnosis.
As this report in MedPage Today states, “Reports of behavioral changes, depressed mood, agitation, hostility, and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA’s adverse event reporting system.”
The typical Chantix course lasts 3 months, and the FDA is recommending regular monitoring for any adverse psychiatric symptoms. Pfizer is doing more studies on the drug, including enrolling patients with schizophrenia into a trial involving Chantix.
What’s a bit surprising is the inclusion of Zyban, also known as Wellbutrin, and generically known as bupropion. It’s a popular antidepressant, and far more patients use it for that purpose, as opposed to smoking cessation. But according to the FDA’s adverse reporting system, there were “14 suicides and 17 attempted suicides in bupropion users.”
I wonder if the withdrawal from nicotine itself is a factor, in addition to the drugs themselves. The black box warning was not unexpected for Chantix, but now doctors will be thinking twice about prescribing bupropion for depression, especially since there are so many alternatives available.
Related posts:
- Does Chantix increase suicide risk?
- Chantix for alcohol abuse?
- Chantix panic?
- Chantix and social marketing
- Chantix: Pfizer’s golden goose?
- Vicodin and Percocet banned and taken off the market, or is a black box warning more likely?
- Chantix a blockbuster?
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Isn’t smoking a slow suicide???
Thanks FDA for making it more difficult for me to help my patients to quit smoking. What you accomplish with this black box warning is not clear.
How many smokers do you know who do NOT have some sort or degree of psych problems??? Personally I haven’t met one in the last 10 years…
Hopefully that will improve health for all on this, the government must give force to the health sector, as there are many people who suffer from chronic illnesses and who need help to cover expenses stronger as fibromyalgia, cancer, producing a series very heavy cost to those who suffer as they must take powerful drugs such as oxycodone, Vicodin, Lortab, drugs that are highly controlled and that findrxonline indicate that opioids are very strong and anxiolytics do not know if that can be given life-threatening that consumes, that is why many times the costs are too high to be able to obtain and soothe the intense pain.
If you’re a longtime heavy smoker, having to quit is darn close to enough to make you suicidal all by itself–not so much the physical nicotine withdrawal as losing that instant psychological boost you’ve depended on for so many years. Maybe the drugs exacerbate it, but it’s bad enough on its own.
In some respects you’re a case of arrested development in terms of dealing with stress, even “good stress,” from the time you started smoking, even if you’re reasonably well adjusted in other respects.
The person who has been smoking for many years and quits goes through what amounts to severe bereavement, and physicians and therapists (not to mention the person trying to quit) need to take that very seriously.
What is the purpose of the black box warning? Does this mean I shouldn’t use it? Or just that I should be scared of lawsuits if I prescribe the drug and the possible adverse reaction occurs? Realy, what is accomplished with the black box warning? So many drugs have them, it really has no meaning anymore, other than helping lawyers in court.
Varenecline has been a remarkable addition and have prescribed it regularly. The black box does prompt me to ask the (hopefully) right questions before I provide the medication.
I agree that it seems odd that one press release was used to announce the new warnings for both drugs. Their mechanisms of action are completely different.
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