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FDA Updates Label for Smoking-Cessation Drug Chantix (Varenicline)

New information includes potential alcohol interaction, seizure risk, and effects on mood, behavior, or thinking

The FDA has warned that the prescription smoking-cessation medication Chantix (varenicline) can change the way people react to alcohol. In addition, rare accounts of seizures have been reported.

The agency has approved changes to the Chantix label to warn about these risks. Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink.

Millions of Americans have serious health problems caused by smoking, which can be reduced by quitting, according to the FDA. Chantix is a prescription medication that is FDA-approved to help adults stop smoking. In clinical trials, Chantix increased the likelihood of quitting smoking and “staying quit” for as long as 1 year compared with placebo.

The FDA reviewed a case series submitted by Pfizer, the manufacturer of Chantix, as well as cases in the FDA Adverse Event Reporting System (FAERS) database describing patients who drank alcohol during treatment with Chantix and experienced adverse events (AEs). Some patients experienced decreased tolerance to alcohol, including increased drunkenness and unusual or aggressive behavior, or they had no memory of things that happened.

The FDA also reviewed FAERS and the medical literature for cases of seizures with Chantix. The agency identified cases in which the patients who had seizures while taking Chantix either had no history of seizures or had a seizure disorder that had been well-controlled. In most of these cases, seizures occurred within the first month of starting Chantix. Information about these risks has been added to the “warnings and precautions” section of the drug label and to the patient medication guide.

The FDA also updated the “warnings and precautions” section of the Chantix label to include information about several studies that investigated the risk of neuropsychiatric adverse effects on mood, behavior, or thinking during treatment with the drug. This information included data from observational studies as well as from analyses that Pfizer conducted of randomized controlled clinical trials. These studies did not show an increased risk of neuropsychiatric AEs with Chantix; the FDA, however, did not examine all types of such effects.

The FDA previously communicated about possible serious neuropsychiatric AEs with Chantix in 2009 and 2011, and these studies were discussed at an FDA advisory committee meeting in October 2014. Pfizer is currently conducting a large clinical safety trial of Chantix to investigate the risk of neuropsychiatric AEs, and results from this study are expected in late 2015.

Source: FDA; March 9, 2015.

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