FDA reviews psychiatric side effects of Chantix

April 25, 2014 by Matthew Perrone

The U.S. Food and Drug Administration announced Friday it will convene a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer's anti-smoking drug Chantix.

The agency said in a federal notice it will convene its panel of psychiatric drug experts to discuss the pill's risks and how to best manage them.

Since 2009 Chantix has carried the government's strongest safety warning—a "black box" label—because of links to hostility, agitation, depression and . The warning was added after the FDA received dozens of reports of suicide and hundreds of reports of among patients taking the smoking-cessation drug.

At that time, the FDA also required Pfizer to conduct additional studies to determine the extent of the side effects.

A spokeswoman for Pfizer said Friday that the company recently submitted new data to the FDA comparing the drug's psychiatric safety to placebo and other anti-smoking techniques.

The FDA first began investigating potential with Chantix in 2007, the year after the twice-a-day pill hit the market.

The drug's labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes. Doctors are advised to weigh the drug's risks against its potential benefits in helping patients quit smoking.

Chantix had global sales of $648 million last year. That was down about 26 percent from the drug's peak sales of $883 million in 2007, its first full year on the market.

Shares of Pfizer Inc. fell 6 cents to $30.65 in morning trading.

Explore further: FDA: studies do not tie Chantix to mental problems

Related Stories

FDA: studies do not tie Chantix to mental problems

October 24, 2011

(AP) -- Federal health officials said Monday that Pfizer's anti-smoking drug Chantix did not increase psychiatric problems like depression and suicidal thoughts in two studies, though the findings are not definitive.

Stop-smoking drug Chantix may carry heart risks, FDA warns

December 13, 2012

(HealthDay)—People who take the prescription quit-smoking drug Chantix may be at higher risk for cardiovascular problems, and doctors should weigh the risks of the drug against it benefits, the U.S. Food and Drug Administration ...

Recommended for you

Researchers identify source of opioids' side effects

January 17, 2017

A commercially available drug may help drastically reduce two side effects of opioid painkillers—a growing tolerance and a paradoxical increased sensitivity to pain—without affecting the drugs' ability to reduce pain, ...

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.