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FDA has approved updated label changes for the smoking cessation drug, varenicline (Chantix, Pfizer).
The updated label will include data from a meta-analysis of 5 clinical trials that showed no increased risk in the incidence of suicidal ideation and/or behavior in patients taking Chantix versus a placebo.
The warnings and precautions section also includes updates on alcohol use and seizures.
Patients are now instructed to reduce the amount of alcohol they consume until they know how Chantix affects their alcohol tolerance, according to drug maker Pfizer.
The label also advised that Chantix should be used with caution by patients with a history of seizures “or other factors that can lower the seizure threshold.”
Pfizer will be discussing the changes with an FDA advisory committee on October 16, according to the company. They also plan to ask the agency to remove the “black box” warning on the Chantix label.
A black box warning is FDA’s strongest medication-related safety warning and highlights major risks. According to the FDA, “drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information... Drugs that have such boxed warnings are not permitted to have reminder ads."
FDA announced July 1, 2009 that it would require Chantix to carry a black-box warning.
More than 10 million smokers in the United States have been prescribed Chantix. It was approved for use by FDA in May 2006.