The United States Food and Drug Administration issued a public warning against a drug used to stop smoking due to its risk of seizures. It may also cause complications such as manifestation of aggressive and unusual behavior if taken with alcohol.
Despite efforts from the pharmaceutical giant to revert the decision of the U.S. FDA, they stand firm on their issuance of a public warning. The stop-smoking drug, Chantix, whose sales hit $647 million worldwide last year, $377 million of that in the United States, was dubbed as the culprit for psychiatric troubles its users suffered and might suffer in the future.
Pfizer aims to persuade FDA to remove its boxed warning over their now-flagship product for its efficacy in actually helping smokers quit smoking. In fact, they released a study published in the Journal of the American Medical Association that Chantix was effective in helping subjects stop smoking compared to placebo treatments.
If the FDA resolution will push through, the boxed warning for Chantix would state risks like agitation, depressed mood, suicidal thoughts, seizures and other behavioral changes including its increased risk for an aggressive behavior if taken with alcohol.
According to FiercePharma, "On the positive side for Pfizer, the FDA did add information about several studies that looked at the risk of neuropsychiatric effects with Chantix, including observational studies and Pfizer's analyses of clinical trial data. The studies didn't show an increased risk of neuropsychiatric side effects, the agency points out."
Chantix, known commonly as varenicline, was approved in 2006. FDA now recommends new packaging labels which would include safety warnings when taking the said medicine. According to Medical News Today, Chantix is a widely-used smoking cessation medicine approved for use by the FDA in 2006. The FDA states that in 2013, an estimated 1.2 million patients received a dispensed prescription for Chantix from outpatient retail pharmacies in the US.
Based from the FDA Adverse Event Reporting System (FAERS) database, users reported decreased tolerance to alcohol that made them manifest intoxication, loss of memory and aggressive or uncharacteristic behavior. Furthermore, users who had no previous history of seizures had bouts and attacks while on medication.
"We urge health care professionals and patients to report side effects involving Chantix to the FDA MedWatch program," the FDA recommends.