FDA Adds Alcohol, Seizure Warnings to Quit-Smoking Pill

Ingram Publishing/Thinkstock(WASHINGTON) — The U.S. Food and Drug Administration on Monday announced the addition of alcohol and seizure warnings on the quit-smoking drug Chantix.

According to an FDA safety announcement, the drug could limit patients’ ability to tolerate alcohol. Other patients suffered seizures, including some who had no history of seizures.

As a result of those findings, the FDA updated the warnings and precautions on Chantix labels to warn about the risks. The FDA says that most cases involving seizures occurred within the first month of starting the drug, and that anyone who has a seizure while taking Chantix should stop taking the medicine and seek medical help immediately.

The FDA previously released statements on the possible neuropsychiatric side effects of Chantix in both 2009 and 2011. Pfizer, the company that manufactures Chantix, is conducting a clinical safety trial to investigate the risks and results from the FDA’s study. Results of Pfizer’s trial are expected in late 2015.

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