>>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.

In 2007, Congress enacted legislation that requires the FDA to release a list of drugs identified through the Adverse Event Reporting System (AERS), which show potential signs of serious health risks. The FDA releases the list about every three months, and the most recent list released on June 4, 2009, identified 19 different drugs or class of medications.

For the period between October 2008 and December 2008, potential skin problems or Stevens-Johnson Syndrome were identified in association with the use of Chantix, Detrol, Provigil, Nuvigil and hydrochlorothiazide in combination products.

Stevens-Johnson Syndrome, commonly referred to as SJS, is a potentially life-threatening skin condition where the skin burns from the inside out. It is almost always associated with adverse drug reactions, and can lead to severe scarring, disfigurement, blindness, organ failure, breathing disorders and death.

When the skin lesions associated with SJS cover more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis, or TEN.

Chantix (varenicline) is a well-known stop-smoking drug manufactured by Pfizer, which is indicated on the list as showing potential signals for “serious skin reactions” as well as several other potential problems. Chantix Stevens-Johnson syndrome reports were first identified early last year in an independent report by the Institute for Safe Medication Practices.

Detrol (tolterodine) is another Pfizer medication, which is prescribed to treat overactive bladders and incontinence. The FDA specifically indicated that the drug has been linked to cases of Stevens-Johnson syndrome and that they are continuing to evaluate the issue to determine the need for any regulatory action.

Provigil (modafinil) was originally identified as having possible connections to SJS and TEN in 2007, after the FDA received six cases of severe skin reactions that included SJS, TRN, and other conditions. Nuvigil (armodafanil) was not mentioned with it at the time, but the FDA put the two drugs together on the potential risks list due to their similarities.

Provigil and Nuvigil already include warnings about potentially severe skin reactions, but FDA says that it is investigating whether more action needs to be taken. Provigil and Nuvigil are used to treat excessive sleepiness due to narcolepsy, sleep apnea or shift work sleep disorder.

The list also notes that the FDA is investigating Hydrochlorothiazide, a diuretic, in combination with other drugs, as a potential cause of skin reactions, but did not specifically identify Stevens-Johnson Syndrome as a concern. The FDA indicates that they are evaluating whether the current labeling is adequate for the various combination products that contain hydrochlorothiazide.

Inclusion of a drug on the list does not mean that it has serious health risks, just that the FDA is investigating possible risks. The FDA will release individual warnings, notices, or labeling requirements once investigations of the potential risks are completed.

STEVENS-JOHNSON SYNDROME LAWYER

The dangerous drug lawyers at Saiontz & Kirk, P.A. investigate potential Stevens-Johnson Syndrome lawsuits throughout the United States. Free consultations are provided to help determine if compensation may be available as a result of a manufacturer’s failure to warn about this serious and potentially life-threatening side effect.

If you, a friend or family member have suffered from Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) after taking a prescription medication, request a free claim evaluation.

>>INFORMATION: Chantix Side Effects

Chantix (varenicline tartrate) is an effective smoking-cessation aid, but it has been found to come at a cost that many consider unacceptable.

Side effects of Chantix have been associated with reports of suicides, suicide attempts, unusual behavior, new on-set diabetes, accidents caused by seizures or black-outs and a possible risk of a severe skin reaction known as Stevens-Johnson Syndrome.

Health Canada, which is the drug regulatory agency in Canada, recently issued a press release for those considering taking the Canadian version of Chantix, marketed as Champix. The government reminded potential users that there are a number of options available to help people quit smoking, both with and without prescriptions.

For those that do decide to use Chantix, Health Canada has made the following recommendations which would also apply to users in the United States:

• Patients, families and friends should be aware of any unusual thoughts, feelings or behaviors, especially those related to depression, agression or self-harm, and the drug should be immediately stopped if there are such concerns.
• Patients should notify their doctor if they have experienced depression or other mental health problems before taking Chantix, as these symptoms may worsen while taking the drug.
• Patients should not drive a car or operate hazardous machinery until they are reasonably certain that Chantix side effects do not adversely affect them

CHANTIX ATTORNEYS

The Chantix attorneys at Saiontz & Kirk, P.A. are investigating potential lawsuits on behalf of individuals who committed suicide, attempted suicide, were diagnosed with diabetes for the first time after taking the drug, suffered severe and debilitating injury from an accident or fall caused by a sudden blackout or seizure, and those who have developed a rare skin reaction known as Stevens-Johnson Syndrome.

To review a potential case about Chantix problems experienced by yourself, a friend or family member, request a free consultation and claim evaluation.

During the third quarter of this year, Pfizer reported sales of $96 million in the United States, which is a 50% drop from the same quarter in 2007, before information about the risk of Chantix suicides was added to the drug’s warning label.

Chantix is a relatively new drug, which received FDA approval in 2006 as a prescription treatment to help people quit smoking. Towards the end of last year, less than two years after it was first introduced by Pfizer, concerns began to emerge about the side effects of Chantix, when a number of adverse events were reported about users committing suicide, having suicidal thoughts and unusual aggressive behavior.

Pfizer first added this information to the warning label in November 2007, and the FDA mandated a “black box” warning in May 2008 about the suicide risk. Concerns have also emerged about the possibility of new-onset diabetes associated with Chantix.
 
According to an independent report from the non-profit Institute for Same Medication Practices, within two years of its approval, Chantix was associated with more adverse event reports than any other medication, including drugs like fentanyl, oxycodone and other drugs used for serious illnesses.

CHANTIX SIDE EFFECT LAWSUITS

The Chantix lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing lawsuits as a result of serious and fatal injuries associated with the use of Chantix. While many drugs carry dangerous side effects, Pfizer failed to disclose the risks of using Chantix, and continue to provide inadequate warning.

If information about the dangers of Chantix had been adequately disclosed, most individuals who are looking to quit smoking to improve their health and prolong their life, would have elected to take other drugs. This is clearly evidenced by the sharp fall in sales, and the continued reluctance of doctors and patients to choose this drug.

If you, a friend or family member have committed suicide, suffered a severe injury from a suicide attempt or been diagnosed with diabetes, request a free Chantix lawsuit evaluation.

>>INFORMATION: Chantix Suicide Side Effects

According to FDA regulations, pharmaceutical companies are required to disclose possible side effects concerning their medications in advertisements and promotional material. This is required so that doctors and consumers can make an informed decision about whether they are willing to accept the potential risks to obtain the benefits of the medication. However, the FDA does not require information about dangers of a product if the advertisement does not specifically name the drug.

In recent weeks, Pfizer has devised a direct-to-consumer advertising campaign for their stop smoking drug Chantix, which is designed to increase sales of the drug by directing consumers to a specific website called MyTimeToQuit.com.

Neither the commercial or the website mentions the name “Chantix” specifically, but clearly both are designed to encourage consumers to talk to their doctors about drug treatments available to stop smoking. The website indicates that they should “learn more” about prescription treatment options, providing a direct link to the Chantix website. However, neither the commercial or the website talk about the potential side effects associated with the prescription treatment, which could increase the risk of suicide, suicidal thoughts or unusual aggressive behavior.

As a result of the serious side effects of Chantix, the FDA has required Pfizer to add stronger warnings to the label about the possible risk of suicide, suicidal thoughts and behavior changes that could result in severe injuries. These warnings were designed to make sure that Chantix users understand that pyschiatric problems can be caused by Chantix.

Despite the intent of these warnings, Pfizer is clearly formulating their advertising campaign around a message that fails to provide information about the negatives associated with the use of Chantix to help people stop smoking. Their executives must believe that they will generate more sales with these ads, than if they ran branded Chantix advertisements which properly informed people of the risks that come with their prescription treatment.

CHANTIX SIDE EFFECT LAWSUITS

There are substantial health benefits associated with quitting smoking. However, there are many safer alternatives to Chantix available to help people stop smoking, and if they are properly informed about the risk of psychological side effects, many smokers would likely choose not to use Chantix.

The Chantix lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits throughout the United States for users who have suffered severe or fatal injuries from a suicide, suicide attempt or unusual behavior. Potential cases are also being investigate for other side effects associated with Chantix, including new on-set diabetes, accidents caused by seizures or sudden blackouts, and a rare skin disorder known as Stevens Johnson Syndrome.

If you, a friend or family member have experienced problems with Chantix, request a free consultation and claim evaluation.

>>INFORMATION: Chantix Side Effects

Concerns about the dangers of Chantix for truck drivers and pilots first surfaced in May 2008. A report by a non-profit group which summarized adverse event reports associated with Chantix, led the Federal Aviation Administration (FAA) to ban Chantix for pilots and air traffic controllers. Around the same time, the FMCSA indicated that doctors should not consider applicants medically fit for a commercial motor vehicle license if they are taking Chantix, as it could increase the risk of a serious accident.

Chantix side effects have been associated with an increased risk of neuropsychiatric symptoms, which could increase the risk of suicide, suicide attempts, agitation, depression and unusual aggressive behavior. In addition, a number of severe injuries have been suffered in traffic accidents caused by Chantix users who suffered problems such as sudden seizures, blackouts, severe muscle spasms, vision problems and hallucinations while driving.

According to an article published on the website for Land Line Magazine, a business magazine for professional truckers, Federal Motor Carrier Safety Administration officials continue to suggest that doctors should not certify truckers who are taking Chantix, as it can impact their ability to safely operate a tractor trailer. However, the regulators have not issued an outright Chantix ban for drivers, and indicate that they do not name any specific medications in FMCSA regulations.

CHANTIX ATTORNEYS

The Chantix attorneys at Saiontz & Kirk, P.A. represent individuals who have suffered severe and fatal injuries caused by side effects of Chantix. Lawsuits are being investigated throughout the United States and there are no fees or expenses unless a recovery is obtained. To review a potential case, request a free consultation and claim evaluation.

>>INFORMATION: Chantix Lawsuits

The study, which was funded by Pfizer, the maker of Chantix, is published in the current issue of the medical journal Thorax. This is the first-ever direct comparison of GlaxoSmithKline’s NicoDerm CQ Clear Patch with Pfizer’s Chantix (varenicline tartrate). The 52-week study involved 746 participants who were randomly administered either Chantix for 12 weeks or NicoDerm for 10 weeks.

The primary endpoint of the study was confirmed abstinence from smoking during the last four weeks of treatment, with secondary endpoints at 24 weeks and one year. While Chantix did beat NicoDerm 55.9% to 43.2% during the last four weeks of treatment, the researchers found that there was no statistically significant different in the quit rates caused by the drugs at six months and one year. Most people look to a medication or treatment to help them quit smoking permanently, so the long-term quit rates are extremely relevant when evaluating the overall benefits of the drug.

Chantix, which was recently approved by the FDA in 2006, has been associated with a number of serious and potentially life threatening side effects, including suicides, suicidal thoughts, depression and sudden violent behavior. Other research has also identified an association between Chantix and diabetes, sudden seizures or blackouts and a potential increased risk of a severe skin reaction known as Stevens Johnson Syndrome.

Prior to the publication of this latest study in Thorax, many users were already indicating that they would not have used Chantix if they had been adequately informed by Pfizer about the side effects. Chantix being no more effective than NicoDerm, an older and safer product, certainly would have impacted the choices made by hundreds of other people looking to quit smoking.

CHANTIX ATTORNEYS

The attorneys at Saiontz & Kirk, P.A. represent individuals throughout the Untied States who are pursuing potential Chantix lawsuits. Cases are being pursued for individuals who died or suffered severe physical injury as a result of a suicide or suicide attempt, as they were not properly warned about this confirmed side effect of Chantix. Potential cases are also being evaluated for users who developed new-onset diabetes, Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, or who suffered a severe injury in an accident or fall caused by a seizure of blackout.

If you, a friend or family member believe you may have a Chantix case, request a free consultation and claim evaluation.

>>INFORMATION: Stevens Johnson Syndrome (SJS) Lawsuits

Stevens Johnson Syndrome, also known as SJS, is a rare but serious medical condition which is caused by an allergic reaction to several different drugs. It causes inflammation of the skin and mucous membranes, literally causing the skin to burn from the inside out. It often requires treatment in a hospital burn unit, and it is fatal in many cases.

The Children’s Motrin lawsuit was filed in the Los Angeles Supreme Court, claiming that Johnson & Johnson failed to warn about the potential Stevens Johnson Syndrome side effects. The young girl was blinded by the development of blisters and sever swelling of the eyelids. However, following a six week trial, the jury found that insufficient evidence was presented to directly link Children’s Motrin to the injury.

While many medications have been associated with SJS, some of the most commonly associated drugs are antibiotics, such as penicillin and sulfas, anti-inflammatory pain medications, such as Bextra and Celebrex, and anti-convulsants, such as Trileptal, Carbatrol, Tegretol and Equetro. SJS has also been associated with the anti-sleep medication Provigil, and the anti-smoking drug Chantix.

STEVENS JOHNSON SYNDROME ATTORNEYS

The product liability attorneys at Saiontz & Kirk, P.A. investigate potential Stevens Johnson Syndrome lawsuits throughout the United States for individuals who have developed this devastating and life-threatening condition. Many medications which could cause Stevens Johnson Syndrome, or a similar skin reaction known as Toxic Epidermal Necrolysis Syndrome (TENS), do not contain adequate warnings about the potential side effect.

If you, a friend or family member have been diagnosed with Stevens Johnson Syndrome or Toxic Epidermal Necrolysis Syndrome, request a free consultation and claim evaluation.

>>INFORMATION: Chantix Side Effects

According to a new study published in the Canadian Medical Association Journal, six different nicotine-replacement therapies, including Chantix, Zyban and Nicotine nasal sprays, patches, tablets and gum, are more than twice as effective at helping people quit smoking for at least six months to a year. The Canadian researchers compared 69 clinical trials involving more than 33,000 people, which demonstrated that the therapies are more effective than placebos, or no smoking-cessation treatment at all.

Although Chantix was found to help people quit smoking, other safer alternatives, such as Nicotine nasal spray were found to be near equally as effective, and Zyban (also known as Wellbutrin), the Nicotine patch and Nicotine tablets were found to be only marginally less effective. These other effective nicotine-replacement therapies do not have the same risks associated with them, which further highlights the importance of providing adequate warnings about the potential problems that could be caused by Chantix.

Over the past year, concerns have grown about the safety of Chantix and the impact the drug has on the brain. Chantix side effects have been linked to a number of psychological problems and other health concerns, which could result in death or serious physical injury. Since the stop-smoking drug was approved in May 2006, the FDA has received hundreds of reports of suicides, suicide attempts, cases of sudden psychosis, hostility or aggression. Earlier this year, the FDA required Pfizer, the maker of Chantix, to add warnings about the risk of these psychological side effects so that smokers can make an informed decision before starting the therapy.

In a related study published in the same issue of the Canadian journal, researchers surveyed smokers to ask whether they were interested in receiving free nicotine-replacement therapy and whether they would use them. According to 825 smokers, 60% indicated that they would be interested in receiving one of the products designed to help them quit smoking, and 94% of those said that they would use to try to quit smoking for good. However, if these same individuals had been informed that Chantix has been linked to an increased risk of suicides, suicidal thoughts and death, how many of these smokers would voluntarily choose to try Chantix, as opposed to one of the other available effective therapies.

CHANTIX SIDE EFFECT LAWSUITS

The Chantix lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who suffered severe physical injury or death as a result of a suicide or suicide attempt while taking Chantix. These users were not provided adequate warnings about the side effects of Chantix, which likely would have led them to choose a different smoking-cessation treatment to help them quit smoking. Potential Chantix lawsuits are also being investigated for users who developed new on-set diabetes, Stevens-Johnson Syndrome or who suffered a severe injury in an accident caused by a sudden seizure or other medical problem which could have been caused by the drug.

If you, a friend or family member have a potential case, request a free consultation and claim evaluation.

>>INFORMATION: Chantix Lawsuits

The Institute for Safe Medication Practices is a non-profit group that monitors FDA adverse event reports on a quarterly basis. During the 4th quarter of 2007, the FDA received 988 adverse event reports involving serious injuries associated with Chantix, which is more than any other medication during the time period.

This raised serious concerns, since the median average for 769 different drugs who had adverse events reported to the FDA during the quarter, was only 5 reports of serious injuries per drug. In addition, only 35 other drugs had more than 100 adverse events reported, and they included drugs like fentanyl, interferon beta, oxycodone, etanercept and other drugs intended for serious illnesses, where the benefits are weighed against known risks typically contained in “black box” warnings.

Based on the way Chantix side effects alter the function of neuroreceptors in the brain, which are responsible for performing many functions throughout the body, the adverse events reported could be caused by the drug. Potential Chantix lawsuits are now being evaluated for:

• Suicide or Suicide Attempt resulting in death or severe physical injury
• Diabetes diagnosis for the first time
• Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis Syndrom (TENS), which are severe skin reactions caused as a medication side effect
• Accidents and Falls resulting in severe physical injury that were caused by seizures, black outs, vision disturbances or other sudden medical problems

If you, a friend or family member have suffered problems which could be associated with Chantix side effects, compensation may be available through a Chantix lawsuit. Review the legal rights which may be available by requesting a free consultation and claim evaluation.

Researchers from the Institute for Safe Medication Practices reviewed reports of Chantix side effects received by the FDA between May 2006 and December 2007. Over the 20 month period, the regulatory agency received reports of:

• 227 Suicides or Suicide Attempts
• 297 Cases of Possible Psychosis
• 525 Reports of Hostility or Aggression
• 173 Accidental Injuries, including road accidents and falls

Some of the other problems noted include reports of heart rhythm disturbances, heart attacks, seizures and diabetes. The numbers presented in the report likely represent only a small fraction of the true number of Chantix problems, as it is generally held that adverse events reported to the FDA only represent about 1% to 10% of all occurrences.

The independent report provides strong evidence that the risks associated with Chantix treatment have been underestimated. When Pfizer introduced Chantix they were not providing any warning to users or the medical community about the potential psychiatric side effects, including an increased risk of suicidal thoughts or behavior. In November 2007, vague information was first added to the label about potential psychiatric side effects. However, the warnings were deminished by conflicting and confusing language.

In January 2008, the label was updated again to include more detailed information about Chantix side effects, such as suicidal thoughts, severe changes in mood and aggressive behavior. The FDA also required Pfizer to develop a medication guide for individuals filling the prescription to include information highlighting the warnings about psychiatric symptoms and the possible risk of suicide on Chantix.

In response to the Institute for Safe Medication Practices’ report, Pfizer issued a statement last week indicating that they believe the current warnings accurately reflect Chantix’s safety profile. However, many experts disagree and feel that stronger warnings should be placed in a “black box” prominently displayed on the label.

The health concerns outlined by the Institute’s report also prompted the Federal Aviation Administration (FAA) to issue a Chantix ban for all pilots and air traffic controllers. Approximately 150 pilots and 30 air traffic controllers who are currently taking the drug will no longer be able to use it because of concerns surrounding the erratic, suicidal and homicidal behavior outlined in the report.

CHANTIX SIDE EFFECT LAWSUITS

The Chantix lawyers at Saiontz & Kirk, P.A. are investigating potential lawsuits on behalf of clients who have suffered severe physical injury or death from a suicide or suicide attempt. If you, a friend or family member have experienced Chantix side effects, request a free consultation and claim evaluation.

>>INFORMATION: Side Effects of Chantix

Reports of suicide and erratic behavior associated with the use of Chantix began to surface late last year. Following an FDA early communication in November 2007 about possible Chantix suicide side effects, Pfizer added vague information to the drug’s label about changes in behavior.

In January 2008, Pfizer updated the label again to feature additional information about suicides and changes in behavior in a more prominent location. The FDA has also indicated that following a review of data, “it appears increasingly likley that there may be an association between Chantix and serious neuropsychiatric symptoms.”

According to a report by Mike Huckman at cnbc.com, Pfizer has worked with the FDA to come up with new ad copy for a re-launched “awareness” campaign to help increase sales of the drug. Unlike prior campaigns, the Chantix ads now indicate that users should notify their doctors if they experience, or their family members observe, changes in behavior, agitation, depressed mood, suicidal thinking or suicidal behavior. Potential users are also now being urged to tell their doctors about any history of depression or mental health problems before requesting a prescription for Chantix.

CHANTIX LAWSUITS

Despite the new warnings and advertisements, Pfizer still faces a large number of potential Chantix lawsuits which are being pursued on behalf of individuals who committed suicide or suffered severe physical injury as a result of a suicide attempt. As a result of Pfizer’s failure to provide adequate warnings about the side effects of Chantix, users were unaware that sudden changes in behavior may be related to the drug. If this information had been disclosed, many serious and fatal injuries may have been avoided.

If you, a friend or family member have suffered severe physical injury or death as a result of the psychiatric side effects of Chantex, request a free consultation and claim evaluation.