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Chantix Fights Free of Black Box Warning

The FDA has okayed removal of a black box warning about serious neuropsychiatric side effects associated with the stop-smoking drug Chantix.

The manufacturer of the stop-smoking drug Chantix received a Christmas gift from the Food and Drug Administration. The medication has carried a black box warning for seven years. It warned of serious neuropsychiatric events, including depression and suicide.

The black box, which is meant to capture the attention of prescribers and patients, advised vigilance for potentially harmful reactions to the drug such as hostility, agitation, behavioral changes and suicide attempts. These might occur while a person was taking the drug or upon discontinuation.

Pfizer’s Side Effects Study:

That black box warning can now be removed. An advisory panel voted narrowly in favor of removal in September, but FDA scientists had wanted to review some inconsistencies in the data Pfizer offered. It had conducted a randomized trial of Chantix, Zyban, nicotine patches and placebo in 8000 smokers, including some with pre-existing psychiatric illnesses.

The Black Box Warning Is Gone:

Last week the agency concluded that the black box could go, but that the serious side effects it mentioned should be included elsewhere in the label. The label is also supposed to say that Chantix is more effective than other medicines to help people stop smoking.

European regulators lifted a similar black box warning from prescribing information there earlier in the year. In most European countries, varenicline (sold in the US as Chantix) is sold under the brand name Champix.

Critics of the FDA decision point out that physicians may be less likely to warn patients about depression, suicidal thoughts, violent acts, psychosis or other serious psychiatric side effects now that the black box is gone. You can read more about such side effects here and here.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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