FDA reviews psychiatric side effects of Chantix

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.

3 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

FDA: studies do not tie Chantix to mental problems

Oct 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.

FDA adds heart warning to Pfizer anti-smoking pill

Jun 16, 2011

(AP) -- Federal health regulators are warning doctors and patients that Pfizer's anti-smoking drug Chantix may slightly increase the risk of heart attack and other cardiovascular problems.

FDA: New warning needed for Chantix

Feb 03, 2008

The U.S. Food and Drug Administration Friday called for increased awareness of the health risks of the smoking cessation drug varenicline.

FDA requires Chantix, Zyban to have warning

Jul 01, 2009

(AP) -- The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency's strongest safety warning over side effects including depression and suicidal thoughts.

Recommended for you

FDA OKs Cubist antibiotic for serious infections

Dec 20, 2014

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

User 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.