FDA Votes In Favor Of Removing Side-Effect Warning On Pfizer's Chantix

Pfizer Inc. PFE's Chantix is a prescription medication that helps adults 18 years and older quit smoking. The drug has been linked with reports of mental health problems, risk of suicide, depression and death in users, which prompted the U.S. Food and Drug Administration (FDA) to issue a "black box" warning in 2009.

According to Forbes, a study in 2015 involving over 10,000 participants found "no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression or death."

Related Link: Compounding, Cigarettes And Savings: How Quitting Smoking Can Save Your Retirement's Life

Pfizer went on to lobby the FDA to remove its "black box" warning, but the request was initially denied.

Another clinical which the FDA had a hand in creating, called EAGLES, consisted of 8,144 smokers who were divided into two groups. The first group consisted of individuals with preexisting psychiatric disorders, and the second group consisted of those without any known disorders.

The study found Chantiz to be more effective than other treatments involved in the study and more effective in helping smokers quit. Moreover, the study also found there was no "“significant increase in neuropsychiatric disorder events attributable to varenicline or bupropion relative to nicotine patch or placebo.”

FDA Panel Vote

The FDA voted on Wednesday to remove the warning associated with Pfizer's drug, according to Reuters.

Reuters noted that 10 of 19 independent panelists to the FDA recommended the "black box" warning be removed. Four of the 19 panelists voted to update the language, and five recommended retaining the language as is.

Attached is an image of our BZ Pro headlines regarding the FDA vote as reported by Reuters.

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