FDA Adds Alcohol and Seizure Warnings to Pfizer's Quit-Smoking Pill

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the Renal and Urology News take:

The FDA has updated the label of the quit-smoking drug Chantix (varenicline) following reports of adverse events.

Clinicians should inform patients that some people taking Chantix have experienced seizures, typically within the first month of use. Before prescribing the medication, physicians need to evaluate a patient’s history and risk of seizures. Tell patients that a seizure requires immediate medical attention and discontinuation of the smoking cessation medication.

Chantix also may interact with alcohol. Some patients have reported increased intoxication, sometimes with aggressive behavior or amnesia. While on the medication, patients should limit their alcohol intake until they know how the drug affects their tolerance.

Chantix already has a black box warning for potential psychiatric effects. The FDA also encourages patients to notify their doctors if they develop agitation, hostility, aggressive behavior, depressed mood, or unusual changes in behavior or thinking, or if they develop suicidal ideation. Pfizer is conducting a post-marketing study, due out later this year, that may clarify the risks.

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In the latest bit of drama surrounding the Chantix quit-smoking pill, the FDA has issued a new safety alert.
In the latest bit of drama surrounding the Chantix quit-smoking pill, the FDA has issued a new safety alert warning consumers about a risk of seizures and to cut back on drinking alcohol while taking the Pfizer drug. The agency also updated the product labeling to note that studies submitted by Pfizer detailing a low risk of psychiatric side effects had limitations. 

However, a Black Box warning, which is the most serious safety alert that can appear on product labeling, was not removed…

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