LAWSUITS NEWS & LEGAL INFORMATION

Chantix Suicide and Side Effects FAQ

What is Chantix?

Chantix (generic name varenicline) is an anti-smoking prescription medicine that treats smoking addiction by blocking the effects of nicotine present in the brain so that the body won't crave nicotine any longer.

Is there a difference between Champix and Chantix?

Except for the name, both medicines have the same active ingredient (varenicline), both are prescribed for smoking cessation, and both are manufactured by Pfizer. However Chantix is available only in the US while Champix is presently approved for sale in Canada and the European Union.

How does Chantix work?

Chantix binds with nicotine receptors in the brain—mimicking a low dose of nicotine for the user. At the same time it blocks nicotine from acting on the receptors, which reduces the satisfaction a smoker receives when smoking a cigarette. Chantix produces an effect that relieves the craving and withdrawal symptoms you can get when you stop smoking.

Are any adverse health effects associated with Chantix?

The FDA received 988 adverse event reports from Chantix users including 224 reports of heart rhythm disturbances. In some reports, the heart rhythm disturbances led to cardiac arrest. 

Most serious adverse health effects that are associated with Chantix involve changes in mood and behavior, including hostility, agitation, depression, suicidal thoughts or actions. The FDA has reported 98 suicides and over 400 attempted suicides in the US alone.

Common side effects include:

• Nausea
• Stomach pain
• Indigestion
• Vomiting
• Constipation
• Weakness and fatigue
• Increase in appetite
• Unpleasant taste in mouth
• Headache
• Insomnia and unpleasant dreams

When was the public warned about Chantix side effects?

In February 2008 the FDA issued a Public Health Advisory alerting health care providers and patients that there is a likely connection between Chantix and severe depression symptoms. The FDA requested that Pfizer, Chantix’s manufacturer, prominently display a safety warning on Chantix’s label detailing the depression risk.

In May 2008, Public Citizen, an advocacy/watchdog group, posted a study online that linked Chantix to loss of consciousness, lapses in alertness, dizziness and muscle spasms. Soon afterward, the Federal Aviation Administration (FAA) banned pilots and air traffic controllers from using Chantix while on the job.

On July 1, 2009, the U.S. Food and Drug Administration (FDA) announced that it is requiring manufacturers to put a black box warning on the prescribing information stating the potential risks, including changes in behavior and mood, hostility, agitation, depression and suicidal thoughts or even suicide.

The Institute for Safe Medication Practices Report linked Chantix side effects-- increased risk of seizure and vision problems in particular--to dozens of automobile accidents, which in turn prompted the Federal Motor Carrier Safety Administration (FMCSA) to prohibit issuing new truck licenses to drivers using Chantix.

Is Chantix safe for me?

Chantix side effects are potentially serious, but they affect a small percentage of consumers. Chantix is likely a safe type of smoking cessation aid, but you should discuss the side effects with your doctor and consider if the benefit outweighs the risks before taking Chantix.

How does Chantix cause depression?

Chantix blocks the brain’s receptors that produce nicotine’s pleasurable effects. Chantix binds itself to the receptors and restricts the receptor’s ability to release dopamine, which is a chemical in the brain that provides sudden and temporary pleasurable feelings. Chantix may also impair the brain’s ability to derive enjoyment from other safe activities. The lack of enjoyment causes depression and suicidal thoughts. Scientists and researchers are currently studying Chantix’s effect on other brain receptors.

Should I take Chantix if I suffer from depression?

Because Chantix alters brain chemistry, it carries a set of risk factors that involve changes in mood and behavior. In February 2008, The FDA announced that it was working with Pfizer to create a Medication Guide for patients describing the increased depression risk.

If you have been diagnosed with depression or any other mental health condition, it is very important to discuss with your doctor whether Chantix is a good fit for you. (See below re: Lawsuit for Lack of Clinical Trials.)

What do Chantix Lawsuits Allege?

There are three main issues regarding Chantix litigation claims.

1. Chantix Lawsuit for Unsafe Drug
   
   Lawsuits allege that Pfizer was negligent because it manufactured and marketed an unsafe drug. The FDA approved Chantix in May 2006 and by the end of the year Chantix was listed among a group of 35 drugs that received more than 100 serious injury reports per calendar quarter. By mid-2007, Chantix was third among all drugs in reported problems and by the end of 2007 Chantix users reported 988 adverse events, more than any other marketed drug. Lawsuits assert that Pfizer should be held strictly liable for manufacturing and marketing this unsafe drug.


2. Chantix Lawsuit for Lack of Clinical Trials
   
   Chantix lawsuits claim that Pfizer did not perform enough clinical trials before it marketed Chantix: during clinical trials, Pfizer did not include individuals with psychiatric history or current psychiatric symptoms. Complaints claim that Chantix was not properly vetted before being released because it was not tested among people with common psychiatric conditions like depression, bipolar disorder and schizophrenia.
   
   Lawsuits allege that if sufficient pre-market testing was performed, Pfizer may have determined that Chantix use was linked to depression and suicide.


3. Chantix Lawsuit for Failure to Warn  
   
   It is alleged that Pfizer did not adequately notify doctors nor warn patients about Chantix’s potential harmful effects.
   
   In November 2007, the FDA notified Pfizer about the potential link between Chantix use and depression, but Pfizer didn't change the Chantix label until six months later. During that delay, thousands of smokers allegedly used Chantix and developed severe side effects.

Can I file a Chantix lawsuit against Pfizer?

If you or someone you love experienced serious side effects, including depressed moods or suicidal thoughts after Chantix use, you may file a lawsuit against Pfizer. Victims can seek compensation for their injuries and file a lawsuit to recover for

• Medical bills
• Loss of income
• Pain and Suffering
• Permanent disability costs