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The Chantix Drug Lawsuit

Varenicline, sold under the brand name Chantix, is used to help smokers quit smoking. Studies indicate that Chantix, when combined with support counseling and behavior modifications, can increase the ability of some users to stop smoking. Unfortunately, some users can also experience an increased risk of cardiovascular events, heart disease, stroke, depression, hostility, and suicidal thoughts.

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What is Chantix?

Marketed by Pfizer, Inc., Chantix is a smoking cessation medication. First approved in 2006, Chantix can help smokers stop smoking by blocking nicotine receptors in the user’s body, thus eliminating or reducing the desire to smoke. Although there have been other smoking cessation treatments, including patches and therapy, Chantix is the first such nicotine receptor partial agonist which has been approved by the Federal Drug Administration (FDA). Unfortunately, within two years, Pfizer received information that Chantix could increase the risk of suicidal thoughts and other psychiatric issues in some users. By 2007, Pfizer decided to display warnings and precautions more predominantly on the packaging. Later in 2009, the FDA required Pfizer to add a Black Box Warning label for Chantix. Pfizer has since added warnings labels which highlight the product’s potential risks of increased serious mental health events, including changes in behavior, depressed mood, hostility, and suicidal thoughts.

What is Chantix used for?

Currently Chantix is only approved for treatment for smoking cessation, but studies are underway to determine if Chantix could be used for alcohol and cocaine addictions.

  • Approved by the FDA for Smoking Cessation.

Chantix Usage and Statistics

Smoking cessation drug Chantix has made millions of dollars for Pfizer. Chantix has also helped thousands of users successfully combat the urge to smoke and was the first smoking cessation drug approved by the Federal Drug Administration (FDA). Unfortunately, despite the success of Chantix, many users have suffered from very severe side-effects from the medication. In fact, within months of the medication’s approval there were troubling reports that the drug could be deadly. According to documents obtained by America Tonight under the Freedom of Information Act, by 2011, Chantix users had suffered an estimated 544 suicides and 1,869 attempted suicides which were all reported to the FDA. Other reports from users indicated that using Chantix could increase the risk for suicidal behaviors, depression, psychosis, and aggression. Oddly, reports indicated that when a user became violent the violence was absolutely unpredictable and senseless and was often committed by individuals who had no history of violence. Pfizer has not been able to replicate the violent side-effects reported to them by Chantix users and maintains that Chantix is a viable and successful treatment option for millions of smokers. To date, the drug has been prescribed to more than 20 million people worldwide.

How Chantix Works

Chantix is an anti-addiction medication which is an alpha-4 beta-2 neuronal nicotinic acetylcholine receptor agonist. Similar to nicotine, varenicline (Chantix) activates a specific receptor for a neurotransmitter called acetylcholine and inhibits the ability of nicotine to bind to and activate the alpha-4 beta-2 receptor. Although the activation is less intense than nicotine, Chantix does seem to reduce the cravings to smoke in a wide number of users and eases withdrawal symptoms.

Side Effects of Chantix

  • Many medical experts are concerned about the side-effects of taking Chantix. Talk to your doctor immediately if you suffer from any of the following side-effects:
  • Hives
  • Difficulty breathing
  • Swelling of your face, lips, tongue, or throat
  • Mood or behavioral changes
  • Anxiety
  • Panic attacks
  • Hallucinations
  • Fear
  • Impulsivity
  • Aggression
  • Restlessness
  • Hostility
  • Depresion
  • Suicidal thoughts
  • Confusion
  • Hyperactivity
  • Chest pain
  • Chest pressure
  • Feeling light-headed or short of breath
  • Sudden numbness
  • Headaches
  • Bruising
  • Unusual bleeding
  • blood in your stool
  • Coughing up blood
  • Fever
  • Sore throat
  • Peeling skin
  • Skin rash
  • Stomach pain
  • Sleep problems
  • Unusual dreams

Chantix Medical Studies

Although smoking has declined significantly in the United States over the last fifty years, reports indicate that nearly 18 of every 100 U.S. adults aged 18 years or older (17.8%) currently smoke cigarettes, accounting for more than 480,000 deaths every year. The good news it there has been significant development in medications and treatment options to help smokers quit smoking. Prior to FDA approval, six clinical trials were conducted for Chantix. The first study investigated the optimum treatment regimen for the drug to prevent successful smoking cessation. The second study compared success rates for claimants under a low-dose and high dose regimen, and the third study examined a flexible dosing strategy. Further studies reviewed long-term abstinence rates following Chantix treatments and investigated the efficacy of the drug on promoting long-term smoking abstinence. In addition to the studies identified above, Pfizer has also conducted studies to determine the multiple-dose pharmacokinetics of varenicline in pediatric patients for efficacy and safety. They have also studied the effects of varenicline in women who have conceived or who are pregnant.

Chantix Black Box Warnings

  • In 2009, the FDA required Pfizer to add a Black Box Warning to Chantix. Pfizer indicates that Chantix can lead to depression, suicide, and suicidal attempts. All patients who are taking Chantix should be under the care of a doctor and should be observed for “neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide.” Pfizer further warns that many of these side-effects can occur in users who prior to the use of Chantix did not have any pre-existing psychiatric illness. Problems can also occur with the discontinuation of the product. If a user experiences any of the above listed side-effects they should immediately contact their doctor and stop taking Chantix. Pfizer advises that although Chantix has successfully helped thousands of smokers quit smoking, the benefits of the product should be carefully weighed against the potential adverse reactions. Pfizer is continuing to investigate reports of violence by Chantix users and must report back to the FDA by 2017. Pfizer has settled an estimated 2,700 Chantix lawsuits to date and has paid users an estimated $300 million dollars in damages.

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