Safety advocates seek stronger warnings on Chantix

Posted: Wednesday, October 8, 2014 10:44 am

Associated Press

WASHINGTON (AP) — Public safety advocates are asking the federal government to strengthen warnings on Pfizer's anti-smoking drug Chantix, even as the drugmaker prepares to argue that a bold-letter warning about psychiatric problems should be removed from its medicine's label.

Five advocacy groups petitioned the Food and Drug Administration on Wednesday to expand Chantix's boxed warning, which currently warns of potential side effects like mood changes, depression, hostility and suicidal behavior. The groups say the label should also include risks of blackouts, convulsions and other problems reported in some patients.

The groups urge the FDA to revisit the boxed warning, first added in 2009, arguing that it "substantially underestimated the psychiatric adverse effects and accident risks of Chantix." They also argue that Chantix should be contraindicated for people working in critical or hazardous occupations, like pilots, air traffic controllers, police and military personnel. The petition notes that the Federal Aviation Administration and the Department of Defense already restrict the use of Chantix.

A spokesman for Pfizer Inc. said the company is reviewing the petition.

The move by safety advocates comes just over a week before the FDA meets publicly to review Chantix's risks. Pfizer has conducted several studies showing no link between its drug and suicidal behavior and the FDA added information from those studies to the drug label last month. Company executives say they plan to use next Thursday's FDA advisory panel meeting to argue that the boxed warning is no longer warranted.

The New York-based company paid more than $275 million last year to settle some 2,500 lawsuits alleging Chantix caused various psychiatric problems, injuries and suicides.

The FDA first began investigating potential side effects with Chantix in 2007, the year after it 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 benefit of helping patients quit smoking.

Pfizer's drug works by binding to the same spots in the brain that are activated by nicotine when people smoke. The drug, known chemically as varenicline, blocks nicotine from binding to those spots and prevents the release of "feel-good" brain chemicals that make smoking so addictive.

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.

Pfizer shares slipped 5 cents to $28.74 in morning trading Wednesday. Its shares are down almost 5 percent over the past three months.

http://www.thedailytimes.com/community/safety-advocates-seek-stronger-warnings-on-chantix/article_538493ae-0331-58fe-8fa8-3fa4e4bfd5e0.html

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I must add, I 'had' a beautiful friend, who used this drug several times to quit smoking. It was hard to believe her doctor would prescribe it again, and again, as they say not to use it that way. This most beautiful spirit turned into a psychotic monster, more hostile than anyone I have ever known. Then became hurtful in so many ways, I almost contacted her family. I decided not to. I quit smoking after starting as a kid. It's now been 19 yrs. Not once was I asked how I did it. I even mentioned that to total silence. One thing that is known, is that you must want to quit. No 'medicine' will just do this for you, unless it's Chantix, that actually changes your brain and creates psychotic episodes that I have witnessed. When you use drugs that work in this way, psychotropic drugs, they deposit into your brain, and change the chemistry of the brain. You don't 'pee' them out like other drugs. They stay there. This new behavior was very noticeable, and intolerable. It ended badly. One of the saddest situations that I have ever known.