The lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Chantix lawsuit against Pfizer as a result of their failure to adequately warn about the risk of suicide and aggressive behavior.

Since our law firm started handling these cases in late 2007, Pfizer has made a number of changes to the drug label and to the warnings that accompany their direct-to-consumer television advertisements. While the current warnings are not as outrageous as those featured in this parody (no you will not get “Jazz Hands”), the Saturday Night Live “commercial” does highlight the outrageous risk that is associated with this prescription medication.

Chantix (varenicline tartrate) is a Pfizer drug that was approved in May 2006 to aid people trying to quit smoking. The drug is not a nicotine replacement product, but rather acts on the brain to diminish the desire to smoke. However, it appears that Pfizer failed to adequately research or study their medication before introducing it and failed to properly warn about the risk of serious and potentially life-threatening Chantix problems.

Setting aside the humor of the SNL Chantix “commercial”, the problems with Chantix are very real and have impacted hundreds of people throughout the United States. The drug has regularly been one of the medications with the most adverse event reports to the FDA’s MedWatch reporting system and it has been linked to more than 400 reported incidence of violence over a five year period, which is more than double the number of instances linked to any other drug on the market in the U.S.

LAWSUITS FOR PROBLEMS WITH CHANTIX

The Chantix lawyers at Saiontz & Kirk, P.A. are continuing to review potential claims involving death or serious injury that may have been caused by the use of the stop smoking drug. To review a potential claim for yourself, a friend or family member, request a free consultation and case evaluation.

>>MORE INFORMATION: Chantix Heart Attack and Stroke Lawsuits

The Chantix lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits on behalf of users of this prescription medication throughout the United States. For several years, our lawyers have been representing individuals and families who are pursuing Chantix suicide lawsuits over the psychiatric side effects of the medication, which were not adequately disclosed to many users. Evidence is now mounting in support of lawsuits for heart attacks and strokes from Chantix as well.

According to a report published this week by the Canadian Medical Association Journal, smokers who took Chantix face a 72% increased risk of suffering a serious cardiovascular event, including a heart attack or stroke, when compared to smokers who were given a placebo.

These findings come only three weeks after the FDA warned that individuals with pre-existing cardiovascular disease may face an increased risk of heart problems and required Pfizer to update the warnings about the potential Chantix heart side effects. However, this study suggests that even individuals without pre-existing heart disease may face an substantial increased risk of problems.

The study looked at 700 smokers who participated in a number of clinical trials and found much higher rates of heart attacks and other cardiovascular events among smokers who took Chantix, as compared to those who took a placebo. One in 28 Chantix users had serious cardiovascular events, even though they had no history of cardiovascular disease or any other heart problems.

Although consumers turn to Chantix to help them quit smoking and improve their health, it appears that the drug may actually increase the risk of heart attacks, strokes and other heart problems people are trying to avoid by quitting.

We have been writing on this blog for some time that the side effects of Chantix outweigh the minimal benefits provided in helping people stop smoking. Two of the researchers involved in this new study found the findings troubling enough to agree that the FDA should now seriously consider issuing a Chantix recall.

Chantix is already the drug linked to the most reported adverse events of any drug on the market. Last month, France pulled the plug on the drug due to the risk of violence and suicide from Chantix, revoking government reimbursements for citizens who decided to risk taking it.

CHANTIX HEART ATTACK AND STROKE LAWSUIT

As a result of Pfizer’s failure to adequately study their drug and warn about the findings of this pre-existing clinical data earlier, individuals who have suffered serious heart problems after Chantix use may be entitled to financial compensation through a Chantix lawsuit for a stroke, heart attack or other cardiovascular event.

The attorneys at Saiontz & Kirk, P.A. provide free consultations and claim evaluations for individuals who suspect that they or a family member may have a claim. All Chantix stroke and heart attack lawsuits are pursued under a contingency fee, which means that there are no attorney fees unless we are successful obtaining compensation for your injury.

>>REQUEST A FREE CHANTIX STROKE OR HEART ATTACK CLAIM EVALUATION<<

>>CONTACT OUR LAWYERS ABOUT CHANTIX HEART PROBLEMS<<

In a drug safety communication issued on Thursday, the FDA indicated that new warnings about the risk of heart problems will be added to the Chantix label and medication guide. According to the federal regulators, individuals with pre-existing cardiovascular disease may face an increased risk of various cardiovascular events, such as:

• Heart Attack
• Angina Pectoris
• Coronary Revascularization
• Peripheral Vascular Disease

The FDA issued the warning after reviewing data from a clinical trial involving 700 smokers, half of whom were given Chantix instead of a placebo to help them quit smoking. Researchers found that 2% of the users of Chantix suffered a heart attack within a year, twice as many as smokers given a placebo, among the other heart problems.

In addition to updating the warning label, Pfizer has been required to conduct a large, combined meta-analaysis of clinical trial data that has been available to them for some time to further evaluate the risk of heart problems from Chantix.

The Institute for Safe Medicine Practices first raised concerns about heart attacks with Chantix use about three years ago. The group identified about 224 reports of Chantix heart problems among adverse events reported to the FDA between May 2006 and December 2007, the first 18 months the drug was on the market. This included reports classified as cardiac rhythm disturbances, heart attacks and other cardiac problems.

The FDA indicates that they are continuing to review and evaluate the risk of Chantix heart side effects and will provide further information in the future. In the meantime, they have asked doctors to weigh the benefits of Chantix in helping people quit smoking against the potential risk of heart problems when deciding whether to use the drug among smokers with cardiovascular disease.

CHANTIX HEART LAWSUITS

When Chantix was first introduced in 2006, the drug maker had high hopes that the medication would become a huge blockbuster. However, concerns about health problems from Chantix have already limited the use of the medication, making it a moderate-sized seller with about $800 million in sales. Concerns about the Chantix heart attack risk is likely to further deteriorate the number of users who will choose to turn to the prescription medication over other methods to help them stop smoking.

Nearly every user of Chantix is looking to quit smoking to improve their health and reduce the risk of heart problems. However, Pfizer failed to adequately warn that Chantix side effects may actually raise the risk of heart attacks for some of these people. As a result compensation may be available through a Chantix lawsuit.

To review a potential claim for a heart attack or other heart problem that occurred after using Chantix, request a free consultation and claim evaluation with our Chantix lawyers.

>>MORE INFORMATION: Chantix Suicide Side Effects

On this blog, we have been calling for a recall of Chantix for a long time due to the increased risk of suicide, suicide attempt, hostility, aggression, depression and psychosis. In addition, prior studies have suggested that the drug may be no better than other treatment options to help people stop smoking.

Last month, the Institute for Safe Medication Practices (ISMP) released a report (PDF) on adverse drug side effects reported to the FDA in the second-quarter of 2010.

Chantix has now caused more than 8,500 reports involving serious injuries, with a steady stream that exceeds most other prescription medications. According to the report, in the second quarter of 2010 alone there were 130 possible cases of Chantix clinical depression, 112 possible cases of hostility-aggression from Chantix and 70 cases of Chantix psychosis and reports by people who say the drug made them lose touch with reality.

ISMP indicated that these case reports continue to exceed the number reported with the most powerful antipsychotic and antidepressant medications, which are used in much more vulnerable groups of patients with mental disorders.

After observing that these Chantix problems continue to be reported, despite the FDA having deployed most of its regulatory tools short of a Chantix recall, ISMP concluded:

The evidence shows that the numerous regulatory actions from the FDA and other restrictions have not succeeded in achieving substantially safer use of (Chantix) varenicline beyond a possible effect in reducing dispensed prescriptions. A major reassessment of this drug’s place, if any, in a program of treatment to assist in smoking cessation is needed.

CHANTIX RECALL LAWSUITS

The Chantix lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Chantix suicide lawsuit or other injury claim from the medication. Despite information that should have led the drug maker to recall Chantix long ago, the medication has been marketed as a safe method of helping people quit smoking.

If you, a friend or family member have suffered a serious injury or death from Chantix, compensation may be available through an individual Chantix lawsuit. To review a potential claim, request a free consultation and case evaluation.

>>INFORMATION: Chantix Lawsuit Evaluations

All federal Chantix lawsuits have been consolidated for pretrial litigation in the U.S. District Court for the Northern District of Alabama before Judge Inge P. Johnson as part of an MDL, or multidistrict litigation. While each case in the MDL remains an individual claim, discovery and other pretrial proceedings are managed in a manner similar to what most people would associate with a Chantix class action lawsuit.

There are currently about 1,200 lawsuits included in the federal Chantix litigation according to a recent report by The Birmingham News. The number of Chantix lawsuit filings is ultimately expected to exceed 2,000, with about 60% of the cases involving a suicide or suicide attempt.

According to a scheduling order issued in October, the first depositions of Pfizer employees will begin in the first quarter of 2011 and the first Chantix trials in the MDL are unlikely to begin until the second half of 2012.

If a Chantix settlement agreement or other resolution for the litigation is not reached after a handful of bellwether trials are heard in the MDL, Judge Johnson then may consider remanding hundreds of individual Chantix suits to federal district courts throughout the United States for trial.

CHANTIX LAWSUIT LAWYERS

The attorneys at Saiontz & Kirk, P.A. are continuing to review new claims on behalf of individuals who committed suicide on Chantix or who suffered a severe and permanent injury from a Chantix suicide attempt. To review a claim and determine whether you, a friend or family member may be eligible to pursue compensation through the Chantix litigation, request a free consultation and claim evaluation.

>>MORE INFORMATION: Chantix Suicide Side Effects

According to a report released earlier this month by Fairwarning.org, it appears that some FDA drug reviewers raised questions about the testing of Chantix before it was approved in 2006. At least one reviewer indicated at the time that without testing of the stop-smoking drug on individuals with mental illness, clinical trials conducted by Pfizer did not represent the true target population of the drug.

Back in March 2008, we posted a blog detailing how the risk of Chantix problems was not fully reviewed before the medication was approved, as individual with a psychiatric history or current psychiatric symptoms were excluded from clinical trials. This means that the drug was not properly evaluated among people with conditions such as depression, bipolar disorder and schizophrenia, which a number of smokers experience.

A large number of smokers battle with problems like depression and anxiety, the added pressure to quit smoking, and the physical and emotional effects of nicotine withdrawal, are likely to aggravate such problems. On top of that, Chantix plays with the brain’s neurochemistry, shutting down its ability to derive pleasure from nicotine, and kicking the brain’s production of dopamine into overdrive. Dopamine is linked to the reward system in the brain, and controls motivation and the psychological high we get when we do things that we enjoy.

If Pfizer had properly evaluated their medication and warned about the risks associated with use, hundreds of Chantix suicides and other violent acts may have been prevented.

According to a new study published this month in the medical journal PLoS ONE, Chantix has been linked to more reported incidence of violence than any other prescription drug over the five year period ending in 2009, with many of the reports involving suicides or suicide attempts.

CHANTIX SUICIDE LAWSUIT

The Chantix lawyers at Saiontz & Kirk, P.A. have been pursuing claims for suicides and suicide attempts with Chantix for the past three years. Individuals who have suffered a severe injury or died as a result of a suicide while using this medication may be entitled to financial compensation through a Chantix suicide lawsuit as a result of Pfizer’s failure to warn about the risk of problems.

To review a potential claim on behalf of yourself, a friend or family member, request a free consultation and claim evaluation.

>>INFORMATION: Chantix Violence Lawsuit

For more than 2 1/2 years, our Chantix lawyers have been representing individuals and families severely injured or killed as a result of this popular prescription medication. While Chantix is designed to help people stop smoking, it has been linked to hundreds or reports of serious injuries or deaths among users and those close to them.

In addition to increasing the risk of suicidal thoughts and suicide with Chantix, users have found that the smoking cessation drug has caused them to lash out at the nearest person in an “uncontrollable rage,” which can result in serious or fatal injuries for both users and their friends or family.

In a report published July 20 online by The Annals of Phamacotherapy, researchers confirmed that there is an association between thoughts and acts of aggression or violence and Chantix. After reviewing adverse event reports from the FDA MedWatch database and other case reports, researchers concluded:

“The clear temporal relationship, lack of prior history of this behavior, and unusual nature of these events strengthens the acumulating scientific evidence that (Chantix) is associated with thoughts and acts of aggression/violence. We recommend that physicians and pharmacists ensure that all patients are informed of possible psychiatric symptoms of (Chantix), including violent and aggressive thoughts. All patients should be advised to contact a health-care provider immediately if these symptoms occur and (Cantix) should be discontinued without delay.”

Researchers say they found some key characteristics that appear to be common to Chantix violent behavior

• Incidents are usually inexplicable and unprovoked.
• The Chantix user attacks anyone nearby.
• There is no prior indication of similar behavior.
• Violence occurs shortly after beginning to take Chantix
• The violent urges go away 93% of the time when Chantix is stopped

Despite the clear association between Chantix and violent behavior, Pfizer continues to defend their blockbuster medication and claims that there is no scientific evidence that Chantix has caused incidents of violent behavior. Although new warnings were added to the medication about the risk of suicide and other psychiatric side effects, not enough is being done to warn consumers and physicians about the risk of violent or aggressive behaviors with Chantix, which can have a devastating impact on their user and their family.

CHANTIX VIOLENCE LAWSUITS

Individual Chantix violence lawsuits as well as potential Chantix class action suits are being reviewed as a result of Chantix side effects and Pfizer’s failure to warn consumers and properly investigate problems associated with their medication.

If you, a friend or family member has suffered serious physical injury or death as a result of Chantix aggressive behavior, compensation may be available through an individual Chantix lawsuit. Contact our Chantix attorneys to request a free consultation and claim evaluation.

>>INFORMATION: Chantix Suicide Lawsuit

A report last month in the Journal of the American Medical Association (JAMA) indicated that the FDA was aware of at least 90 reports of Chantix suicides and 188 suicide attempts as of July. This is up from a documented 19 suicides and 15 suicide attempts between May 2006 and November 2007, when the first warnings were added to the medication.

Chantix (varenicline) was approved by the FDA in 2006 as a prescription medication to help people stop smoking, and it has proven to be effective. However, while most people look to stop smoking so that they can improve their health and prolong their life, side effects of Chantix have been associated with a disturbing risk of suicidal thoughts and behavior.

Rather than recalling Chantix, the FDA announced earlier this year that Pfizer will be required to add a “black box” warning to inform users and the medical community that users may experience an increased risk of psychiatric side effects, which can include sever and fatal injuries from suicide attempts, aggressive behavior and other behavioral changes.

Allowing the drug to remain on the market with increased warnings is designed to give smokers an opportunity to weigh the risk against the benefits. However, given alternative methods that are available to help people quit smoking, it does not seem that the benefits could outweigh the risk of damage that Chantix behavior changes can have on a user and their family, raising the question of why a Chantix recall has not yet been issued.

CHANTIX SUICIDE LAWYERS

The attorneys at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing a Chantix suicide lawsuit for severe or fatal injuries suffered. Pfizer failed to adequately research the Chantix problems before introducing and heavily marketing their drug to users. Potential cases are also being reviewed for users who have suffered severe physical injury from sudden abnormal behavior, accidents or falls caused by seizures or blackouts, new on-set diabetes from Chantix and for individuals who have developed rare skin reactions known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis.

To speak with a Chantix lawyer and have a potential claim reviewed to determine if compensation may be available for yourself or your family, request a free consultation and claim evaluation.

>>PRIOR POST (6/11/2008): Chantix Stevens-Johnson Syndrome Side Effects
Added to Lawsuit Investigations

Stevens-Johnson Syndrome, commonly referred to as SJS, is a rare skin reaction that can occur as a side effect of several medications. It results in severe rashes and blistering of the skin and mouth, where the skin literally burns from the inside out. It often requires treatment in a hospital intensive care unit (ICU) or burn care unit, and it can result in death. If the top layer of the skin detaches from the lower layers and lesions cover more than 30% of the body, SJS is often diagnosed as Toxic Epidermal Necrolysis (TEN) or Lyell’s Syndrome.

Concerns about potential Chantix and Stevens-Johnson Syndrome arose after an independent report by the Institute for Safe Medication Practices examined FDA adverse event reports involving Chantix from the 4th quarter of 2007. Several users of the stop smoking drug reported suffering severe and debilitating skin reactions consistent with Stevens-Johnson Syndrome.

Last month, the potential Chantix SJS skin reactions were noted on a quarterly report by the FDA of drugs they were investigating for potential health risks that emerged between October 2008 and December 2008. The FDA indicated that Chantix was showing potential signals for “serious skin reactions,” as well as other problems.

According to a press release issued by Pfizer on July 1, 2009, in addition to the boxed warning about behavior changes and suicidal tendencies, the following new information was added to the Warnings and Precautions sections of the Chantix warning label:

Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

CHANTIX STEVENS-JOHNSON SYNDROME (SJS) LAWSUITS

The Chantix lawyers at Saiontz & Kirk, P.A. are reviewing potential Stevens-Syndrome lawsuits for individuals who have been diagnosed with the severe skin reaction, which could involve symptoms like:

• Rash, blisters or red spots on the skin
• Blisters in the mouth, eyes, ears, nose or genital area
• Swelling of the eyelids
• Fever or flu-like symptoms

Potential Chantix lawsuits are also being reviewed for suicides and suicide attempts, new on-set diabetes and catastrophic injuries from a fall or accident caused by seizures, black-outs, vision disturbances or other sudden problems.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

>>FDA ANNOUNCEMENT: Zyban and Chantix Black Box Warning

For over 18 months, the lawyers at Saiontz & Kirk, P.A. have been investigating potential Chantix suicide lawsuits, alleging that Pfizer failed to adequately warn about these problems. After receiving hundreds of reports involving users who suffered severe or fatal injuries from a suicide attempt on Chantix, the FDA is finally requiring Pfizer to take stronger steps to ensure that people are aware of the risk.

The FDA first indicated that they were reviewing the side effects of Chantix in November 2007. In response, Pfizer updated the drug’s label, but provided vague and confusing indications about a connection between Chantix and suicide, suicidal thoughts and other changes in behavior. Since that time the drug maker has made several other updates to the warning label, but the FDA’s actions yesterday make it clear that Pfizer has not done enough to protect the public from the Chantix dangers.

While we have suggested before that a Chantix recall may be necessary, since the risk of suicides and other life-threatening side effects seems to outweigh the minimal benefits that the drug provides over other methods that people can use to stop smoking, Chantix will remain on the market. The FDA suggested that with the stronger warnings, consumers and their doctors will be able to weigh the risk of Chantix side effects against the benefits.

In addition to Chantix, the warning will also be placed on Zyban, another prescription drug for smoking cessation. According to an FDA statement released Wednesday:

The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

CHANTIX SUICIDE ATTORNEYS

Pfizer’s failure to properly research their medication and warn about the Chantix suicide problems when they first placed the drug on the market in 2006, prevented consumers and health care providers from making an informed decision about whether to take the drug. In addition, many consumers who suffered severe or fatal injuries in a suicide or suicide attempt could have contacted their doctors or sought help if they had been notified that the drug may be responsible for their sudden changes in behavior.

The Chantix attorneys at Saiontz & Kirk, P.A. are continuing to review potential cases for individuals throughout the United States. In addition to cases for injuries or death caused by a suicide or suicide attempt on Chantix, lawsuits are also being investigated for new on-onset diabetes from Chantix, serious skin reactions like Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis and accidents or falls caused by seizures, blackouts or other sudden problems.

If you, a friend or family member have a potential Chantix lawsuit, contact our attorneys and request a free consultation and claim evaluation.