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• Apr 1, 2008 12:00 am US/Central
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  Chantix Investigation: From FDA Approval To Market

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Chantix Investigation: From FDA Approval To Market

May 11, 2006: FDA OKs Pfizer Anti-Smoking Pill
A Pfizer drug shown to help more than one in five smokers quit after a year's use received federal approval. Varenicline is only the second nicotine-free smoking cessation drug to gain Food and Drug Administration approval. Pfizer Inc. markets the twice-daily tablet as Chantix. (AP)

Sept. 29, 2006: Anti-Smoking Pill Gets OK In Europe
Pfizer Inc. said Friday that the European Commission has approved anti-smoking pill Champix. The medication, varenicline, received Food and Drug Administration approval as an aid to quitting smoking in May, under the tradename Chantix. (AP)

July 9, 2007: Anti-Smoking Pill May Help Curb Drinking
A single pill appears to hold promise in curbing the urges to both smoke and drink, according to researchers trying to help people overcome addiction by targeting a pleasure center in the brain. The drug, called varenicline, already is sold to help smokers kick the habit. New but preliminary research suggests it could gain a second use in helping heavy drinkers quit, too. (AP)

Sept. 3, 2007: Dallas Musician Killed After Domestic Disturbance
Jeffrey Carter Albrecht, 34, was inebriated Monday when the wife of his girlfriend's neighbor began screaming around 4 a.m. that someone was breaking in, police said. After telling Albrecht to get away, the husband fired his handgun through the door and shot Albrecht in the head, police said. Albrecht had been fighting with his girlfriend. (AP)

Sept. 6, 2007: Parents Of Killed Dallas Musician Talk To CBS 11
No one really knows what set Albrecht off. His parents confirm that he was taking the prescription drug Chantix to quit smoking. The Albrecht's believe the drug mixed with alcohol altered their son's mood.

Sept. 24, 2007: Chantix: Miracle Drug Or Dangerous Problem?
CBS 11 News aired the first of many investigative stories into the anti-smoking drug Chantix, revealing thousands of adverse reaction reports to Chantix in the FDA database.

People from across the country reported aggressive behavior, suicidal thoughts and depression. Click here to read the responses.

Oct. 25, 2007: Drugs Tested On Few Before Released To The Masses 
CBS 11 News reports drug manufacturers and the FDA say they test new drugs on a few people before releasing them to the masses, effectively using the general population as guinea pigs.

Oct. 30, 2007: Report Can't Confirm Killed Musician Used Chantix
Officials at the Dallas County Medical Examiner's Office said they could not test Albrect for Chantix. However, they did find Albrecht's blood alcohol level was above the legal limit at the time of his death.

Nov. 20, 2007: FDA: Chantix May Be Tied To Suicidal Behavior 
The FDA first informed the public about the possibility of serious neuropsychiatric symptoms in what it terms "Early Communication." At that time, information about serious neuropsychiatric symptoms in patients taking Chantix was added to the POST-MARKETING EXPERIENCE section of the prescribing information for Chantix.

Nov. 27, 2007: Suicide Concern Tied To Anti-Smoking Drug In UK
The Medicines and Healthcare products Regulatory Agency, the United Kingdom's version of the U.S. Federal Drug Administration, announced it has received troubling reports from patients using the drug Champix.

Some people reported having suicidal feelings while on the drug and the organization said it is monitoring the drug closely.

Dec. 3, 2007: UK Newspaper Reports Suicide Of Man Taking Chantix
The Bolton News reported 39-year-old Omer Jama, a popular television editor, slashed his wrists just weeks after beginning a course of pills to help him quit smoking.

Dec. 10, 2007: Warnings For Anti-Smoking Pill Linked To Suicide 
Packs of Champix will carry new warnings of links with suicidal thoughts when it hits the Australian market in January 2008. 

Dec. 13, 2007: More Report Adverse Effects After Taking Chantix 
CBS 11 has learned the number of people in the United Kingdom reporting suicidal thoughts while using the drug Champix, which is known as Chantix in U.S., doubled in just 60 days.

Jan. 18, 2007: Pfizer Changes Chantix Label
As FDA's review of the issue progressed, the agency said it appeared increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.

As a result, FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the WARNINGS and PRECAUTIONS sections of the Chantix prescribing information.

In addition, FDA began working with Pfizer to finalize a Medication Guide for patients.

Feb. 1, 2008: FDA: Anti-Smoking Drug May Pose Psychiatric Risks
The FDA sent notice that these sections of the label had been updated at FDA 's request. Also on that day, the FDA released the following alert:

FDA ALERT [2/1/2008]: FDA is issuing this Alert to highlight important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms. Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

Feb. 12, 2008: Magazine Writer's Chantix Experiences Detailed
A writer for New York Magazine says he never believed stories that Dallas musician Carter Albrecht's death could've been blamed on Chantix until he tried the drug himself.

Derek de Koff says he started having strange dreams, then paranoia set in days into taking prescription.

(© MMVIII, CBS Broadcasting Inc. All Rights Reserved.)

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