PharmExec Blog

Chantix and Zyban Get Boxed Warnings

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FDA announced yesterday afternoon that the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) must bear black box warnings for serious mental health symptoms, including changes in behavior, hostility, depression, and attempted suicide.

In addition to being used in smoking cessation, buproprion is also marketed as an atypical antidepressant under the brand name Wellbutrin, as well as in a generic form. All these products will receive increased warnings highlighting the risks for mental health events. (The drugs already carry black box warnings for suicidality.)

According to FDA, symptoms have occurred in patients with and without histories of psychiatric illness, and tend to occur shortly after medication starts and end when treatment is stopped. But there have been instances reported where side effects continue even after the patient stops taking the drug.

According to raw FDA numbers, 98 people taking Pfizer’s Chantix committed suicide, while 14 people took their lives while on GlaxoSmithKline’s Zyban. One hundred eighty-eight people attempted suicide on Chantix, and 17 tried while taking Zyban.

“It has been difficult to evaluate some of these cases, as we are working off adverse event reports,” said Bob Rappaport, director, Division of Anesthesia, Analgesia and Rheumatology Products, CDER. “People who stopped smoking without using medication may also report similar symptoms in nicotine withdrawal. However, we examined some cases where people were using the products under discussion and also had the adverse events while smoking.”

Rappaport admitted in a teleconference that both smoking cessation aids are effective, and possible risks should be weighed against the health benefits of quitting smoking.

Both companies can continue to advertise the drugs, but additional warnings must be added to the risk statements. However, they will no longer be allowed to run reminder ads.

About Time or Too Late?
Chantix came under fire last year in the blogosphere and media as hundreds of consumers began posting on Web forums that they had become increasingly depressed while on the smoking cessation drug.

Minutes after FDA announced the call for increased warnings, Pfizer released a statement saying that it would update its labeling to add the black box warning and adjust the current warning. Pfizer wouldn’t comment whether recent public scrutiny has affected sales, or whether the company will retool its sales force in light of the new warnings.

Zyban, Really?

The black box for Zyban, however, is a bit of a surprise.

“We looked at three products [including nicotine replacement treatments] to get some sort of idea if Chantix would stick out,” Rappaport said. “We were surprised to find that Zyban seemed out to have the same characteristic of [adverse] reporting and the same reporting rates. So this is a new thing for Zyban.”

Pfizer and GSK are being required to conduct clinical trials to determine incidents of mental health symptoms in people trying to quit smoking, including people with and without pre-existing mental conditions.

FDA said that it doesn’t expect the results of the trials to be revealed for several years.

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  1. carly
    Posted July 1, 2009 at 7:24 pm | Permalink

    First the Percocet and Vicodin problems and now this. Time for changes at the FDA. There is a related post at

  2. Posted July 2, 2009 at 9:06 am | Permalink

    I smoked for 22 years, quiting for 3 months at a time but no longer than that. I never could truely kick the habit. I have tried the patch with no success at all. Welbutrin did make me very agressive and didn’t work. Then I tried Chantix. I started the pill and 9 days later I felt no different. Day 10, I awoke and lit a cigarette and almost puked. I have not had one since and this has been 1 1/2 years.

    Chantix did not cause me to have depression or mood swings, however Welbutrin did cause agressiveness. I think that the black box warnings are good and everyone should be made aware that if they start feeling strange then the drug is not for them and they should stop immediately. I do not feel that Chantix should be taken off the market. I will stand behind it for life because it has allowed me to kick the habit.

  3. Miguel Gordillo
    Posted July 2, 2009 at 11:31 am | Permalink

    These are changing times that permits one to conclude a sense that the FDA is entering a state of higher acuity. As a student hoping to enhance upon the human condition, it is understood that brain chemistry and the resulting mood is of a complexity that is, comprehensively, NOT readily understood. It is therefore that we must contemplate with care and diligence when pharmaceuticals (synthetic drugs not quite Mother Earth’s tea) are administered. The latter upon a realm more fragile because it deals with the most sensitive and complex human organ.

    Thus, when quitting smoking or treating depression, one must never negate the need of another to persuade the negative effects promulgated, or not, by the rigors being abated. Hence, it is wonderful how the human touch could be regarded as the synergist (to the drugs) that yields success. There is a medicament being formulated that holds the above in sight: biotechnology based nicotine antibodies! These do not invade the brain with added chemicals, rather, they prevent nicotine from entering the brain. Considering that this injection will prove worthy, the professionals formulating such miracle always consider the power of the human touch. The vaccine, Nabi NicVax, is not even a pharmaceutical but embraces the human mood.

    Am I alone in the thinking that the pharmaceutical drugs far from embrace the human mood by its encapsulating or exacerbating mechanisms? Whatever happened to talk therapy when dealing with phenomena of the mind…such complexity is not to be addressed with a forceful resolve. Thank you FDA for beginning a new trend. By the way, what is going on with Drug Resistant Bacteria? Have we reached 100K annual deaths? (1994=14K)

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    Posted February 17, 2011 at 5:43 am | Permalink

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  5. Posted April 25, 2011 at 7:40 pm | Permalink

    The mental health symptom of Chantix alone would make me not want to touch it.

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