Download CHANTIX (varenicline tartrate )

CHANTIX
(varenicline tartrate )
ROBERT A. SCHWARTZ
Executive Vice President
Managing Attorney - Houston
Attorney in Charge of Mass Tort and Commercial Litigation
Bailey & Galyen
18333 Egret Bay Blvd., Suite 120
Houston, Texas 77058
(281) 335-7744 Main phone
(866) 715-1529 Toll free
(281) 335-5871 Fax
web site: http://www.pinjury.com
e-mail: [email protected]
Licensed in Texas and Missouri
CONFIDENTIAL ATTORNEY WORK PRODUCT
THE SMOKING PROBLEM
According to the Centers for Disease
Control and Prevention (CDC), an
estimated 45 million adults in the United
States smoke cigarettes, and more than 8
million of them have at least one serious
illness caused by smoking.
PFIZER FOUND THE CURE FOR
TOBACCO SMOKING ADDICTIONS
• PFIZER’s new prescription quit smoking
pill:
– CHANTIX (U.S.)
– CHAMPIX (Europe and other nations)
APPROVED TREATMENT
• Approved course of Chantix treatment: 12 weeks
– For the first three days, patients take 0.5 milligram
(mg) once a day,
– followed by 0.5 mg twice a day for the next four
days, and
– then 1 mg twice a day for the remainder of the
treatment period.
Patients who successfully quit smoking during Chantix
treatment may continue with an additional 12 weeks of
treatment that further increases the likelihood of longterm smoking cessation.
FDA Consumer Magazine
July-August 2006
The FDA Approves New Drug for Smoking Cessation
In May 2006, the Food and Drug Administration approved Chantix (varenicline
tartrate) tablets to help cigarette smokers ages 18 and older stop smoking.
The drug received a priority review because of its significant potential benefit to public
health. Chantix was reviewed in six months rather than the regular review time of 10
months, says Curt Rosebraugh, M.D., M.P.H., deputy director of the FDA's Office of
Drug Evaluation II. "Chantix underwent priority review," Rosebraugh says, "because at
the time the application was filed, a preliminary review of the efficacy studies indicated
that smokers treated with Chantix may have a superior rate of smoking cessation
compared to Zyban (bupropion), another currently approved product for smoking
cessation."
Chantix acts at sites in the brain affected by nicotine and may help those who wish to
give up smoking in two ways: by providing some nicotine effects to ease the
withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they
resume smoking. Rosebraugh says, "If someone slips up, they would probably not
have the reinforcement that they would normally get from smoking a cigarette."
QUESTION:
IS IT SAFE AND EFFECTIVE?
PFIZER SAYS:
• The effectiveness of Chantix in smoking cessation was demonstrated in six
clinical trials, which included a total of 3,659 chronic cigarette smokers
who were treated with varenicline. Five of the six studies were
randomized, controlled clinical trials in which Chantix was shown to
be superior to placebo in helping people quit smoking. These smokers
had previously averaged 21 cigarettes a day for about 25 years.
•
In two of the five placebo-controlled studies, Chantix-treated patients
were also more successful in giving up smoking than patients treated with
Zyban. "Both studies had very similar results with approximately 44
percent of people taking Chantix having stopped smoking at the end
of 12 weeks, compared with 17 percent of people who were taking
placebo and 30 percent of people taking bupropion," Curt Rosebraugh,
M.D., M.P.H., deputy director of the FDA's Office of Drug Evaluation II says.
"Researchers followed study participants in both studies for a year
and found that approximately 22 percent of people taking Chantix, 16
percent of people taking bupropion, and 10 percent of people taking
placebo were still smoke-free at the end of the year.
THE REAL STORY
ON PFIZER’S STUDIES
• A closer look at three comparable studies using
1mg of Chantix twice daily published in July and
August 2006:
• Gonzales
– 21.9%* of Chantix users were still not smoking at one year.
• Oncken
– 22.4%* Chantix users were still not smoking at one year.
• Jorenby
– 23%* Chantix users were still not smoking at one year.
– That's an average one-year rate of 22% still not
smoking after a year, or, a relapse rate of 78%.
A 78% RELAPSE RATE DOES NOT SUPPORT
EFFICACY.
*these rates were achieved under highly artificial clinic study conditions.
SIDE AFFECTS AND ADVERSE
REACTIONS
• Pfizer's patient information insert lists only five
"common" side effects: nausea, followed by changes
in dreaming, constipation, gas, and vomiting.
• Pfizer’s separate insert for doctors lists* different
adverse reactions: suicidal thoughts, aggression,
and neurological and psychiatric disorders.
• In Europe, where the drug is known as Champix, the
United Kingdom’s Commission on Human Medicines
(similar to the FDA) lists Champix on its new drugs
under intensive surveillance and discussed a potential
signal of a risk of "suicidal thoughts and behaviors"
associated with this pill.
*in 1-millimeter size print smaller than used in this note
PFIZER’S CHANTIX WEBPAGE
FOR DOCTORS
• PSYCHIATRIC DISORDERS
– Frequent: Anxiety, Depression, Emotional disorder,
Irritability, Restlessness.
– Infrequent: Aggression, Agitation, Disorientation,
Dissociation, Libido decreased, Mood swings,
Thinking abnormal.
– Rare: Bradyphrenia, Euphoric mood, Hallucination,
Psychotic disorder, Suicidal ideation
PFIZER’S CHANTIX WEBPAGE
FOR CONSUMERS
Side Effects and Safety
• What are the possible side effects of
CHANTIX?
– The most common side effects of CHANTIX include:
– Nausea, sleep disturbance (trouble sleeping,
changes in dreaming) constipation, gas, vomiting.
• Tell your doctor about side effects that bother
you or that do not go away.
• These are not all the side effects of CHANTIX.
Ask your doctor or pharmacist for more
information.
IS IT OR ISN’T IT SAFE?
• Pfizer says YES:
– Chantix is safe and
– There is no causal association between Chantix and
violence.
• Getting it’s safety information from Pfizer,
the FDA says YES:
– Chantix is safe and effective when used according to
the product's label.
• September, 2007, Washington D.C. political
watchdog group Public Citizen put Chantix on its
worst pill list.
CONCLUSION
CHANTIX IS NEITHER SAFE
OR EFFECTIVE