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FDA Allows Pfizer’s Chantix to Drop Black Box Warning

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The study found that patients taking Chantix as a quit-smoking aid were no more likely to suffer serious neuropsychiatric events – such as psychosis, paranoia and delusions – compared to a placebo.

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December 22, 2016 | by Sarah Hand, M.Sc.

The US Food and Drug Administration (FDA) has updated its labelling requirements for Pfizer’s quit-smoking drug, Chantix. Based on the results of an 8,144 patient post-marketing study of the drug, the regulator has approved the removal of a black box warning from the product’s packaging.

The study found that patients taking Chantix as a quit-smoking aid were no more likely to suffer serious neuropsychiatric events – such as psychosis, paranoia and delusions – compared to a placebo. The warning label was originally added to Chantix in 2009, three years after the drug was approved by the FDA.

While the FDA doesn’t hesitate to add a warning label to drugs that have been associated with serious adverse events, they don’t often make the decision to remove the warning. However, in September the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 10 to 9 to remove the warning label from Chantix.

“For millions who smoke, stopping smoking is one of the most important steps they can take to improve their health, and Pfizer is committed to helping smokers in their quit journey,” said Dr. Freda Lewis-Hall, chief medical officer and EVP, Pfizer Inc. “We are pleased with the FDA’s decision to update the Chantix labeling based on EAGLES – the largest clinical trial of smoking cessation medications - and we expect this new information may further facilitate an informed discussion about quitting with Chantix between smokers and healthcare providers.”



Pfizer’s placebo-controlled EAGLES clinical trial was designed to determine whether neuropsychiatric effects in smokers who did, or did not, have a history of mental illness, were associated with Chantix, bupropion or nicotine patches. In patients without a history of psychiatric disorder, Chantix did not increase the incidence of neuropsychiatric adverse events. However, Chantix was associated with a 2.7 percent higher risk of these side effects in patients with a history of mental illness, compared to the placebo.

“While the benefits of quitting are immediate and substantial, few smokers are able to quit on their own and need the help of counseling and smoking cessation therapy,” said Dr. A. Eden Evins, director, Massachusetts General Hospital Center for Addiction Medicine and William Cox Family Associate Professor of Psychiatry in the Field of Addiction Medicine, Harvard Medical School. “As healthcare providers work on the front lines to help people who are struggling to quit smoking, this new labeling provides clinically relevant information on the safety and efficacy of Chantix to help them and their patients make informed decisions about smoking cessation treatment.”


Keywords: FDA, Smoking, Black Box Warning


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