FDA WARNS OF ALCOHOL INTOLERANCE, SEIZURES WITH VARENICLINE (CHANTIX)

March 11, 2015

Here’s an important alert for patients taking the smoking cessation drug varenicline (CHANTIX).

On March 9, 2015, the Food and Drug Administration (FDA) issued a safety communication warning the public about two additional, serious side effects of varenicline.[1]

The agency presented new data that it had received from Pfizer, CHANTIX’s manufacturer, as well as reports from patients and physicians to the FDA Adverse Event Reporting System (FAERS), of patients experiencing seizures shortly after starting the drug. Most seizures occurred within a month after starting varenicline, and all cases occurred either in patients with no history of seizures or in patients whose seizure disorder had been well controlled.

The FDA also described reports in FAERS and medical articles of patients drinking alcohol while on varenicline who experienced “decreased tolerance to alcohol, increased drunkenness, unusual or aggressive behavior, or … no memory of things that happened.”[2] In none of the 48 cases reported to FAERS was the amount of alcohol consumed excessive for the patient or sufficient to explain the event.

The FDA updated varenicline’s label in September 2014 to include these two side effects. In October 2014, Public Citizen and four other nonprofit consumer advocacy and research groups petitioned the FDA to strengthen varenicline’s existing black-box warning to include the following severe psychiatric and neurological side effects that could potentially harm patients or others: psychotic symptoms, blackouts, convulsions, impaired vision, unexplained hostility, anger and aggression towards others.[3] The petition also asked that the label warn against any use of the drug in patients working in sensitive or hazardous occupations, such as pilots, air traffic controllers, military missile crew members, police, firefighters and emergency medical workers.

What you can do

If you smoke, you should try to quit as soon as possible. While varenicline is effective in helping people quit smoking, it comes with many risks. You should see your doctor to determine a comprehensive quitting strategy, and we recommend that you first try nicotine patches, gums or other forms of nicotine replacement therapy, along with professional counseling to help you quit.

Only if none of these safer strategies work should you consider varenicline, after carefully considering the risks. However, you should never use varenicline if you work as a pilot, air traffic controller, policeman, firefighter or emergency medical worker, or if you work in another occupation where the drug’s side effects could harm you or others.

For more information on our petition, see this month’s issue of Worst Pills, Best Pills News, or visit http://www.citizen.org/hrg2225.

To see the FDA safety communication, visit the following link: http://www.fda.gov/Drugs/DrugSafety/ucm436494.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.

References

[1] Food and Drug Administration. FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking. March 9, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm436494.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed March 10, 2015.

[2] Food and Drug Administration. FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking. March 9, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm436494.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed March 10, 2015.

[3] Public Citizen joins other groups in requesting additional warnings on CHANTIX label. https://www.worstpills.org/member/newsletter.cfm?n_id=950. Worst Pills, Best Pills News. March 2015. Accessed March 10, 2015.